ISO 14000 Series - ISO 14001:2004

ISO 14001 Standard & Environmental Issues

2010-06-28T06:36:00.001-07:00

ISO 14001 Standard & Environmental Issues

ISO 14001 is a systematic tool that enables an organization in any market sector to focus on their situation, identify the relevant environmental issues and to lessen their impact to their benefit and the environment. It is part of a global response to the recognition that we are damaging the environment in which we all live. The cause and effect of the foremost world environmental issues, which are all due to mankind, are generally too vast and too intangible for us to grasp and so the slightly cliché expression ‘think global, act local’ is very relevant. Once the EMS is implemented and to become registered to ISO 14001, the external auditor will assess your EMS in two separate stages, on site. The first stage to understand your business activities and determine formal readiness for assessment and the second to check practical compliance with ISO 14001. After registration he will return at regular intervals every year to verify continual improvement and regulatory compliance, against your set objectives and your EMS. The external auditor should be seen as a wise friend, not a policeman. He should certainly explain his findings and assist the company to find ISO 14001 registration is not a cure for all environmental problems but I hope I’ve demonstrated that it is a worthwhile, if not essential business initiative that could enable your management to better manage your business, gain commercial advantage and minimize its environmental impact.

The ISO 9001 & ISO 14001 Standards and the environment

2010-05-09T06:59:00.001-07:00

The ISO 9001 & ISO 14001 Standards and the environment

In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.

On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total more
than 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.

They also serve in a number of countries as the technical basis for environmental regulations.

ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in

1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.

ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.

This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.

Today, delegations of business and government experts from 55 countries have participate actively within TC 207,

and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.

This national consensus is derived from a process of consultation with interested parties.

From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.

The Environment For A Healthy Business In ISO 14001 Standards

2010-04-10T15:45:00.001-07:00

The Environment For A Healthy Business In ISO 14001 Standards

Growing scrutiny toward industry’s effects on the environment has made conformance with ISO 14001:2004 – a voluntary, internationally recognized Environmental Management Systems(EMS) standard – more important than ever. As more companies pursue ISO 14001 certification to demonstrate environmental commitment to their customers, shareholders and government agencies, many are discovering the benefits of partnering with Intertek. As one of the first accredited certification bodies, Intertek offers expertise, experience and know-how that no one else can deliver. Your certified EMS can help you reap the benefits of:

Improved overall performance
Your ISO 14001 certified EMS can help make your business more efficient and productive. Lower energy and raw materials use, reductions in waste and pollution, and mitigated risks of accidents and emergency situations translate into greater profitability and productivity.

Expanded market access
Your company’s environmental credibility and commitment to quality are established from day one. It will take less time to demonstrate the effectiveness of your EMS and earn your prospective customers’ trust and confidence, and you’ll enjoy access to markets you might not otherwise penetrate.

Improved corporate image
Your certification demonstrates your company’s commitment to environmental responsibility, fostering improved relationships with the community, shareholders, and governmental and environmental organizations.

Enhanced competitiveness
While helping you to operate more efficiently and profitably, your ISO 14001 certified EMS can instill additional confidence in shareholders, investors, insurers and your customers – making your business the clear choice in a highly competitive market.
Plus, you can maximize your human and financial resources by using your existing Quality Management System (QMS) as a basis for your EMS, taking advantage of the synergies between ISO 9001 and ISO 14001.

The ISO 9001 & ISO 14001 Standards and the environment

2010-04-10T15:43:00.000-07:00

The ISO 9001 & ISO 14001 Standards and the environment

In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.

They also serve in a number of countries as the technical basis for environmental regulations.

1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.

Today, delegations of business and government experts from 55 countries have participate actively within TC 207,

This national consensus is derived from a process of consultation with interested parties.

Quality Management System Requirements

2010-04-05T05:51:00.000-07:00

Quality Management System Requirements
The ISO 9001:2008 standard is meant to be generic and applicable to all kinds of organizations. Therefore, organizations from both the public and private sectors, including non-governmental organizations can benefit from the ISO 9001 quality management system model, regardless of whether they are small, medium or large organizations. The immediate benefit that can be realized from the implementation of ISO 9001 is the collective alignment of the activities of internal processes that are focused towards the enhancement of customer satisfaction which will result in many other benefits, whether internal or external. The magnitude of these benefits are determined by how effective the processes are in achieving its objectives.

What is ISO 14000 Standards?

2010-01-16T22:31:00.000-08:00

What Is ISO 14000 Standards?

ISO 14000 is primarily concerned with Environmental Management. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.

Improving the environmental performance of corporations is one way of limiting environmental damage. Environmental management systems (EMSs), such as ISO 14001, provide a framework for organizations that wish to effectively manage their environmental affairs. Implementing an EMS that conforms to the ISO 14001 standard may help businesses integrate environmental values into their operations.

An EMS can be described as a program of continuous environmental improvement that follows a defined sequence of steps drawn from established project management practice and routinely applied in business management. In simple terms these steps are as follows:
• Review the environmental consequences of the operations.
• Define a set of policies and objectives for environmental performance.
• Establish an action plan to achieve the objectives.
• Monitor performance against these objectives.
• Report the results appropriately.
• Review the system and the outcomes and strive for continuous improvement.
Not every system will present these steps in exactly the same way, but the basic principles are clear and easily understandable.

The ISO 14000 series is a series of standards for different aspects of environmental management. A number of these standards relating to environmental management systems have been adopted formally by the members of the ISO, while others are in different stages of preparation.

ISO 14001 ENVIRONMENTAL MANAGEMENT SYSTEM AUDIT

2009-11-14T19:15:00.000-08:00

ISO 14001 Standards - Environmental Management System

ISO 9001 Standards – Document Repository

2009-09-21T06:02:00.002-07:00

Useful Aids to Implement ISO 9001 Standards

2009-09-21T06:02:00.001-07:00

Useful Aids To Implement ISO 9001 Standards

Many companies implement ISO 9001 without using all the available tools. As a result, some companies may not fully optimize their implementation. This issue could be manifested as confusion over terms, misunderstanding about requirements, and perplexity concerning intention.
ISO, the International Organization for Standardization, based in Geneva Switzerland issues thousands of standards, but we limit our scope to ISO 9001:2008 and its immediate “family”.
This includes ISO 9000:2005 and ISO 9004:20002. ISO 9001 is a general industry standard for quality management, but ISO also issues industry specific standards. Many of these standards, such as ISO 13485 for medical devices, are based on ISO 9001 and can also utilize these available tools.

In addition to the information discussed below, ISO also issues standards related to specific activities that may arises in a quality management system. The following lists these supporting documents.

Automotive ISO/TS 16949:2002
Education IWA 2:2007
Energy PC 242, ISO 50001
Food safety ISO 22000:2005
Information security ISO/IEC 27001:2005
Health care IWA 1:2005
Local government IWA 4:2005
Medical devices ISO 13485:2003
Petroleum and gas ISO 29001:2003
Ship recycling ISO/PAS 30000:2008
Supply chain security ISO 28000:2007

Process Approach In ISO 9001 Standards Posted by everise | iso 9001 standard | Thursday

2009-09-21T06:01:00.000-07:00

Process Approach In ISO 9001 Standards

The process approach was introduced into ISO 9001 with the year 2000 version of the standards.
Prior versions used an element approach. The document Guidance on the concept and use of the process approach for management systems describes to process approach and offers an implementation paradigm.
1. Identification of processes of the organization
1.1. Define the purpose of the organization
1.2. Define the policies and objectives of the organization
1.3. Determine the processes in the organization
1.4. Determine the sequence of the processes
1.5. Define process ownership
1.6. Define process documentation
2. Planning of a process
2.1. Define the activities within the process
2.2. Define the monitoring and measurement requirements
2.3. Define the resources needed

2.4. Verify the process and its activities against its planned objectives
3. Implementation and measurement of the process
4. Analysis of the process
5. Corrective action and improvement of the process Implementation
This document explains the process used to evaluate changes to the 2008 version. In particular, it explains the revision process and illustrates the impact vs. benefit analysis used to evaluate potential changes.
In addition to the guidance documents, ISO maintains a web site with “official interpretations” of ISO 9001. Currently, these interpretations only include ISO 9001:2000, but, because the changes to the 2008 version were limited, they are valuable.
Consider a common question. An organization needs a documented procedure for preventive action (8.5.3), and must keep records of the results of preventive action (8.5.3.d). One of the interpretation requests asks, “Does sub-clause 8.5.3 a) require organizations to demonstrate, with objective evidence in the form of records, that they have undertaken actions to determine the existence of ‘potential nonconformities and their causes’?” The answer is “No”.
Auditing Practices
The ISO 9001 Auditing Practices Group maintains a website9 with guidance and information on auditing ISO 9001 quality management systems. It is an informal group of quality management system (QMS) experts, auditors, and practitioners drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).
The website, primarily aimed at QMS auditors, consultants, and quality practitioners, is an online source of papers and presentations on auditing a QMS and reflect the process based approach.
The website contains almost forty guidance documents with practical advice ranging from “How to audit top management processes” to “The role and value of the audit checklist”.

Quality Planning

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Whenever the term “product” is used within the ISO 9001 standard, it refers to both tangible goods and intangible services. The ISO 9001 standard is meant to be generic which means that it is suitable for all kinds of organization, whether commercial or otherwise. The purpose of the quality management system model that is being propagated by the standard is the fulfillment of customer requeirements and expectations in order to induce high levels of customer satisfaction. An unsatisfied customer is essentially a customer whose requirements or needs, and expectations of the level of services being granted upon him/her have not been met. We are all customers because we buy products all the time. So we know what it means to be a dissatisfied customer. The common reaction is to never to go back to that seller and look for other alternatives. A successful organization is one which understands what it takes to meet customer requirements in order to satisfy their needs and expectations. A specific process is thus necessary to resolve any customer complaint or dispute. This process should be geared towards satisfying the customer’s needs and expectations. The parameters of this process should be referenced from the terms of the sale and purchase. This is why it is necessary to review the customer’s requirements before committing to the sales contract. It is necessary that the customer understands what he/she is paying for and it is equally necessary for the organization to understand what it is supposed to deliver. When your organization has these processes in place, then the only thing to do next is to continually measure the effectiveness and subsequently take actions to continually improve the whole process.

ISO 9001 Standards Software

2009-09-21T05:59:00.002-07:00

ISO 9001 Standards Software

Companies that need quality management systems realize that products like ISO 9001 software are important tools to insure their product safety, consistency and profitability. Using ISO 9001 software can help guarantee that any company can monitor productivity, customer satisfaction and product quality with reports that contain solid information.

This information is now vital to management in order for maximum efficiency in any industry. This is why ISO 9001 software is vital to any sized company. Continuous improvement means continuous profitability. Here are just a few reasons why:

o Companies increase sales because of better performance, quality, and delivery. This propels you ahead of your competition.

o ISO 9001 software helps retain employees and attract more highly qualified employees because they are assured of a controlled and consistent work environment.

o The experience of a more professional workplace boosts employee morale.

o Reduced operating costs dramatically increase your company’s productivity, leading to higher profitability.

o Customer satisfaction and higher profitability expand your market share and demand for your consistently higher product quality.

o When you’re compliant or certified to the appropriate standard, the businesses that work with you know that quality objectives, continuous improvement, and customer satisfaction are your goals.

Many companies require that their suppliers are ISO 9001 compliant; therefore, once you’re certified, your opportunities increase. ISO 9001 software has be utilized and has developed experience of helping manufacturing, service, and distribution organizations to be more efficient and more profitable through continuous improvement programs. We help you to implement the time-tested methods of continuous improvement to measure performance, analyze data, and apply the appropriate process changes. This includes using ISO 9001 software.

ISO 9001 software also offers a suite of modules to enable you to manage the document management and ISO 9001 Compliance Management process. These modules enable complete transparent system measurement with targeted action items ensuring all persons are notified of tasks and carry them out in a prompt and efficient manner. ISO 9001 software provides training in there software and also bring extensive experience in implementing the ISO 9001 software in various environments.

ISO 14001 And The Environment

2009-09-21T05:59:00.001-07:00

In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.

They also serve in a number of countries as the technical basis for environmental regulations.

1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.

Today, delegations of business and government experts from 55 countries have participate actively within TC 207,

This national consensus is derived from a process of consultation with interested parties.

ISO 9000 and ISO 14000 in plain language Posted by everise | iso 14001 | Friday 11 September 2009 3:21

2009-09-21T05:58:00.002-07:00

Both “ISO 9000” and “ISO 14000” are actually families of standards which are referred to under these generic titles for convenience. Both families consist of standards and guidelines relating to management systems, and related supporting standards on terminology and specific tools, such as auditing (the process of checking that the management system
conforms to the standard).

ISO 9000 is primarily concerned with “quality management“. In the everyday context, like “beauty”, everyone may have his or her idea of what “quality” is. But, in the ISO 9000 context, the standardized definition of quality refers to all those features of a product (or service) which are required by the customer. “Quality management” means what the organization does to ensure that its products or services satisfy the customer’s quality requirements and comply with any regulations
applicable to those products or services.

ISO 14000 is primarily concerned with “environmental management”. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.

In addition, both ISO 9000 and ISO 14000 require organizations that implement them to improve their performance continually in, respectively, quality and environmental management.

Both ISO 9000 and ISO 14000 concern the way an organization goes about its work, and not directly the result of this work. In other words, they both concern processes, and not products – at least, not directly. Nevertheless, the way in which the organization manages its processes is obviously going to affect its final product.

In the case of ISO 9000, the efficient and effective management of processes is, for example, going to affect whether or not everything has been done to ensure that the product satisfies the customer’s quality requirements. In the case of ISO 14000, the efficient and effective management of processes is going to affect whether or not everything has been done to ensure a product will have the least harmful impact on the environment, at any stage in its life cycle, either by pollution, or by depleting natural resources.

However, neither ISO 9000 nor ISO 14000 are product standards. The management system standards in these families state requirements for what the organization must do to manage processes influencing quality (ISO 9000) or the processes influencing the impact of the organization’s activities on the environment (ISO 14000). In both cases, the philosophy is that management system requirements are generic. No matter what the organization is or does, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features which are spelled out in the relevant ISO 9000 or ISO 14000 standards.

ISO 9000 and ISO 14000 in plain language

2009-09-21T05:58:00.001-07:00

ISO 14000 is primarily concerned with “environmental management”. In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities.

In addition, both ISO 9000 and ISO 14000 require organizations that implement them to improve their performance continually in, respectively, quality and environmental management.

ISO 9001 Standards In General

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ISO 9001 Standards In General

The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by
— its business environment, changes in that environment, or risks associated with that environment,
— its varying needs,
— its particular objectives,
— the products it provides,
— the processes it employs,
— its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
The quality management system requirements specified in this International Standard are complementary to requirements for products. Information marked “NOTE” is for guidance in understanding or clarifying the
associated requirement.
This International Standard can be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer, statutory and regulatory requirements applicable to the
product, and the organization’s own requirements.
The quality management principles stated in ISO 9000 and ISO 9004 have been taken into consideration during the development of this International Standard.

ISO 9001 – Compatibility with other management systems

2009-09-21T05:56:00.002-07:00

ISO 9001 – Compatibility with other management systems

ISO 9001 and ISO 9004 are quality management system standards which have been designed to complement each other, but can also be used independently.
ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, for certification, or for contractual purposes. It focuses on the effectiveness of the quality
management system in meeting customer requirements.
ISO 9004 gives guidance on a wider range of objectives of a quality management system than does ISO 9001, particularly for the continual improvement of an organizations overall performance and efficiency, as well as its effectiveness. ISO 9004 is recommended as a guide for organizations whose top management wishes to move beyond the requirements of ISO 9001, in pursuit of continual improvement of performance. However, it is not intended for certification or for contractual purposes.

During the development of this International Standard, due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community.
This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, financial
management or risk management. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for
an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard.

Certification In ISO 9001 Standards Posted by everise | iso 9001 standard | Sunday

2009-09-21T05:56:00.001-07:00

Certification In ISO 9001 Standards

Certification involves an independent assessment of your quality system to confirm that it meets the requirements of ISO 9001. You will need to design, document and implement your own quality system. The system will need to cover all the requirements of the ISO 9001 standard. Many certification bodies will not conduct a formal assessment until the system has been operating for at least three months. Your quality system cannot be audited until you have generated documentary evidence to show that you are meeting the standard. To find a certification body with relevant experience in your sector and accreditation from the United Kingdom Accreditation Service (UKAS). Certification by a non-UKAS accredited body is likely to lead to credibility problems with your customers. Arrange a visit from the certification body’s auditors. UKAS prohibits auditors from acting as consultants. They will not tell you how to meet the standard but can offer advice. They will seek objective evidence that you are complying with each of the clauses of the ISO 9001 standard. The auditors will tell you of any shortcomings in your system. If you satisfy the standard, the auditors put your name forward for certification. You will be required to correct these problems within a specified timeframe. You can also be certificated if the auditors only identify a small number of ‘minor’ problems. Once you are certificated, you can display the certification body’s logo, and if the body is UKAS-accredited, the UKAS ‘tick and crown’ symbol (consult UKAS about exceptions to this rule). If the auditors identify more serious ‘major’ problems, you will be required to correct these before certification. These surveillance visits normally take place twice a year at agreed dates. All certification bodies are required to revisit registered companies to ensure they still meet the requirements of the standard. You will be given time to deal with any minor or major problems which are identified before any action is taken to withdraw your certificate.

Costs and resources Of ISO 9001 Standards

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Costs and resources Of ISO 9001 Standards

The largest cost of ISO 9001 is the involvement of company

employees. The ‘ownership’ created by involving employees in designing the quality system maximises the chances of them accepting it. Reducing this cost by minimising employee involvement is a false economy. The next largest cost will be for designing and developing the system. This needs to be led by someone with experience in this particular field. You may have someone within your own organisation who has carried out this role, perhaps with a former employer. Your Business Link may offer free or subsidised advice and training, and will be able to provide names of approved consultants. Grants for work in this area tend to be directed through Business Links. Different areas have different grants, which depend on local conditions. A typical grant may cover up to 50 per cent of the cost of an approved consultant. Certification fees are around £800 for the smallest companies. Overall costs depend upon company size and the number of locations involved. Ask certification bodies for quotes for initial audits and surveillance visits. Many will give an all-inclusive price, including surveillance visits for three years. Typically, special rates will depend on how long the assessment is likely to take and what the company’s turnover is. Ask your certification body if it offers special rates for small companies. The standard requires that companies have trained internal auditors to conduct audits on the system. An internal audit can provide an effective means of monitoring the system and identifying areas for improvement. For further details, contact the International Register of Certificated Auditors.

ISO 9000 family of standards and SMEs

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ISO 9000 family of standards and SMEs

The ISO 9000 quality management system is generic in nature and applicable to all companies, regardless of the type and size of the business, including small and medium enterprises (SMEs), and they are applicable to all categories of products, whether hardware, software, processed materials or services. ISO 9001:2008 specifies what is required to be done by an organization but does not indicate how it should be done, thus giving the enterprise a lot of flexibility to run its business.

It is simple to use, clear in language and easily understandable. The new standard is also appropriate for small companies, as it does not demand the type of paper bureaucracy needed for the implementation of the 1994 version. Only six documented procedures are now required and need for other procedures/documents can be decided by the company. Companies will, however, be required to provide objective evidence that the QMS has been effectively implemented. A small company may find it appropriate to include the description of its entire QMS within a single Quality Manual, including all the documented procedures required by the standard.

The process-based approach given in the new standard will tend to ensure that systems are documented and implemented in a manner that suits a SME’s own way of doing business. This approach makes it easier for SMEs to implement, instead of just taking over an artificial structure of QMS imposed from outside. It will also be easier for SMEs managed by their owners to demonstrate “top management commitment” towards QMS. Furthermore, in a SME, it is easier to ensure effective internal communication, better utilization of resources, people clearly understanding their roles and responsibilities, etc.

The new standard has included a provision for deciding on the applicability of

certain product realization processes included in section 7 of the standard. For example, if the SME has no responsibility for the design and development of the product it provides, the SME may say so, giving the reasoning behind it, in the Quality Manual; the certification body, being satisfied that this corresponds, would then award it certification to ISO 9001:2008. Similarly, other product realization processes such as purchasing, product identification and traceability, control of measuring devices may also be excluded if these are not applicable for the type of products or services being provided by the company.

It is also possible that SMEs may not have adequate in-house expertise or there may be other constraints to perform all processes on their own. In such cases, the new standard also permits the outsourcing of any of the QMS processes, providing the company has control over such processes. The nature of this control will depend on the nature of the outsourced or subcontracted processes and the risk involved. For example, the design and development process may be subcontracted to an expert or a specialized agency, inspection/verification of goods purchased may be subcontracted to an inspection agency, internal audit of QMS can be outsourced, etc. However, overall responsibility for ensuring control on all outsourced processes as per requirements of the standard would remain with the company’s management.

Management Principles Of ISO 9001 Standards

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Management Principles Of ISO 9001 Standards

ISO 9000 is based on eight management principles:

• Customer focus, resulting in meeting customer requirements and striving to exceed them;

• Leadership, aiming to create an internal environment in which people are fully involved;

• Involvement of people who are the essence of an organization;

• Process approach, resulting in improved efficiency to obtain desired results;

• System approach to management, leading to improved effectiveness and efficiency through identification, understanding and management of interrelated processes;

• Continual improvement, which becomes a permanent objective of the organization;

• Factual approach to decision-making, based on the analysis of data and information; and

• Mutually beneficial supplier relationships, based on an understanding of their interdependence.

ISO 9000 encourages the adoption of the process approach to manage an organization. There are five main areas considered for the revised process model in ISO 9000:

• Quality management system

• Management responsibility

• Resource management

• Product realization

• Measurement, analysis and improvement.

Costs Of Setting Up A Quality Management System

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Costs Of Setting Up A Quality Management System

Common implementation costs that companies incur can be broken down into direct and indirect costs.

The direct costs include, inter alia, the following:

• hiring consultants or external trainers, if required;

• sending personnel for external training;

• acquiring relevant national and international standards of the ISO 9000 family and other related books and publications; and

• acquiring additional equipment, instruments and other resources as identified by the company.

The indirect costs include, inter alia, the following:

• time spent by the management and other staff in developing the system;

• reorganization of the processes, including improvements in the house-keeping, if required;

• external calibration charges for equipment to ensure national and/or international measurement traceability;

• organizing in-house training;

• time spent by internal auditors for periodic internal audits;

• corrective actions, including revision of manuals and procedures, if required; and

• expenditure on word-processing, stationery and other consumables required for the preparation of manuals and documenting procedures, etc.

Some factors can help to lower the above costs. They include:

• having people in the company already conversant with QMS requirements;

• having documented system-related activities such as work instructions, quality plans, procedures, etc. already in place;

• using consultants only for specific activities like gap analysis, training of

auditors, pre-assessment audits, etc., and having in-house staff oversee the remaining activities.

On the other hand, there are factors that can mean higher implementation costs for the company. For example, if your company carries out activities at different locations, or if your company is involved in product design and development, this may increase costs.

Benefits Of Obtaining ISO 9000 Certification

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Benefits Of Obtaining ISO 9000 Certification

Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-à-vis the outside world.

Internal benefits to the company include:

• improved customer focus and process orientation within the company;

• improved management commitment and decision-making;

• better working conditions for employees;

• increased motivation of employees;

• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,

• continual improvement of the quality management system.

The following external benefits are generated:

• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;

• an improved image of the company;

• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;

• more confidence that the company’s products meet relevant regulatory

requirements;

• better objective evidence to defend product liability charges if such are brought by customers.

Refer http://www.iso9001-standard.us/ for more information.

Implementing A Quality Management System

2009-09-21T05:51:00.002-07:00

Implementing A Quality Management System

An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:

1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.

At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).

2. Obtain information about the ISO 9000 family

The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.

Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;

3. Appoint a consultant, if necessary

If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.

Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.

4. Awareness and training

Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.

The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.

5. Gap analysis

Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.

6. Product realization processes

Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.

The processes covered by this clause include:

• Customer-related processes

• Design and development

• Purchasing

• Production and service provision

• Control of measuring and monitoring devices

Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.

7. Staffing

Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.

8. Planning a time frame

Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and

7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.

9. Draft a Quality Manual

In your Quality Manual;

• Include how the QMS applies to the products, processes, locations and departments of the organization;

• Exclude any requirement with justification for doing so as decided in step 6

above;

• Refer to or include documented procedures for QMS;

• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and

• Draft the quality policy and quality objectives for the organization.

The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.

The effective date of implementation should also be decided.

10. Carry out internal audits

During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.

11. Apply for certification

On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.

12. Conduct periodic evaluations

After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.

ISO 9001 Standards – Management Review

2009-09-21T05:51:00.001-07:00

ISO 9001 Standards – Management Review

Review the quality management system at planned intervals to:- Assess possible opportunities for improvementEnsure a suitable, adequate, and effective system

- Evaluate the need for any changes to the system

- Consider the need for changes to the quality policy and objectives

Maintain records of the management reviews.

Inputs for management review must include information on:

- Results of audits

- Customer feedback

- Process performance and product conformity

- Status of preventive and corrective actions

- Follow-up actions from earlier reviews

- Changes that could affect the quality management system

- Recommendations for improvement

Outputs from the management review must include any decisions and actions related to:

- Improvement of the effectiveness of the quality management system and its processes

- Improvement of product related to customer requirements

- Resource needs

ISO 9001 Standards – Design and Development

2009-09-21T05:50:00.000-07:00

ISO 9001 Standards - Design and Development

Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions

- Stages of design and development

- Appropriate review, verification, and validation activities for each stage

- Responsibility and authority for design and development

The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.

NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.

Determine product requirement inputs and maintain records. The inputs must include:

- Functional and performance requirements

- Applicable statutory and regulatory requirements

- Applicable information derived from similar designs

- Requirements essential for design and development

Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.

Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:

- Meet design and development input requirements

- Provide information for purchasing, production, and service

- Contain or reference product acceptance criteria

- Define essential characteristics for safe and proper use

- Be approved before their release

Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:

- Evaluate the ability of the results to meet requirements

- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.

ISO 9001 Standards – Control of Measuring and Monitoring Equipment

2009-09-21T05:49:00.000-07:00

ISO 9001 Standards - Control of Measuring and Monitoring Equipment

Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
Where necessary to ensure valid results:

- Calibrate and/or verify the measuring equipment at specified intervals or prior to use

- Calibrate the equipment to national or international standards (or record other basis)

- Adjust or re-adjust as necessary

- Identify the measuring equipment in order to determine its calibration status

- Safeguard them from improper adjustments

- Protect them from damage and deterioration

Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.

Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).

NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.

For More Information Please Visit http://www.iso9001-standard.us/

ISO 14001:2004 Standards Contents Posted by everise | iso 14001 | Sunday 13 Septem

2009-09-21T05:48:00.002-07:00

ISO 14001:2004 Standards

ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.

The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.

ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.

Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.

Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).

Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.

ISO 14000 is a series of voluntary standards and guideline reference documents.

The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.

Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).

Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.

ISO 14000 is a series of voluntary standards and guideline reference documents.

ISO 14000 is an Environmental Management System (EMS) who’s purpose is:

· A management commitment to pollution prevention.

· An understanding of the environmental impacts (reducing) of an organization’s activities.

A commitment (pollution prevention) to employees, neighbors and customers

ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.

The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.

ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.

Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.

The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).

The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.

The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.

As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.

In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.

The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:

· implement, maintain and improve an environmental management system

· assure itself of its conformance with its stated environmental policy

· demonstrate such conformance to others

· seek certification/registration of its environmental management system by an external organization

· make a self-determination and self-declaration of conformance with this international standard.

All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.

ISO 9001 Standards New Blogs

2009-09-21T05:48:00.001-07:00

Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:

http://iso14000standards.blogspot.com/

http://iso-9001-standards.blogspot.com/

http://iso14001environmentmanagementsystem.blogspot.com/

http://iso9001qualitymanagementsystem.blogspot.com/

http://iso9001qualitymanual.blogspot.com/

http://iso9000standards.blogspot.com/

http://iso9001-standards.blogspot.com/

http://iso14001standards.blogspot.com/

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System Posted by everise | ISO Quality Management System | Sunday 20 September 2009 4:

2009-09-21T05:47:00.001-07:00

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System (QMS)

- An Romania Perspective

The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.

Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.

The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.

Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.

Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.

ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.

The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.

Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.

The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.

ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.

The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.

The documentation of QMS involves:

1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)

2. Management Responsibility

3. Resource Management

4. Product Realisation

5. Measurements, Analysis and Improvement

A well managed quality system will have impact on:

1. customer loyalty and repeat business

2. market share

3. operational efficiencies

4. flexibility and ability to respond to market opportunities

5. effective and efficient use of resources

6. cost reductions

7. competitive advantages

ISO 9001 Standards – Documented Procedures

2009-09-21T05:46:00.002-07:00

ISO 9001 Standards – Documented Procedures

The standard requires the management system documentation to include documented procedures required by ISO 9001 Standards.

ISO 9000 defines a procedure as a specified way to carry out an activity or a process. This definition is ambiguous because an activity is on a different scale than a process. Process outputs are dependent upon many factors of which activities are but one. An activity is the smallest unit of work. Several activities accomplish a task and several tasks reflect the stages in a process but there is more to a process than a series of tasks. This definition also esults in a belief that procedures are documented processes but this too is inaccurate. Procedures tell us how to proceed don‘t need to produce any others. The specific procedures required are:

(a) A documented procedure for document control

(b) A documented procedure for the control of records

(d) A documented procedure for nonconformity control

(e) A documented procedure for corrective action

(f) A documented procedure for preventive action

These areas all have something in common. They are what the authors of the early drafts of ISO 9000 :2008 referred to as system procedures ? they apply to the whole system and are not product, process or customer specific although it is not uncommon for customers to specify requirements that would impact these areas. Why procedures for these aspects are required and not for other aspects of the management system is unclear but it seems that the authors of ISO 9000 felt these were not processes ? a conclusion I find difficult to justify.

They are certainly not business processes but could be work processes. However, there is another message that this requirement conveys. It is that procedures are not required for each clause of the standard. Previously, countless organizations produced a manual of 20 procedures to match the 20 elements of ISO 9001. Some limited their procedures to the 26 procedures cited by the standard and others produced as many as were necessary to respond to the requirements.

Document control is a work process or a number of work processes because the inputs pass through a number of stages each adding value to result in the achievement of defined objectives. These are the acquisition, approval, publication, distribution, storage, maintenance, improvement, and disposal stages. These are not tasks but processes that achieve defined objectives and involve both physical, financial and human resources. Within these processes are tasks, each of which may require documented procedures as they are initiated.

Control of records is also a work process similar to document control. There are the preparation, storage, access, maintenance and disposal stages. This is not one uninterrupted flow but a life cycle. There is not one task but several performed at different times for different reasons.

Auditing is certainly a process with a defined objective. Without the provision of competent personnel and a suitable environment, audits will not achieve their objectives no matter how many times the procedure is implemented.

Nonconformity control like records control is a work process for the same reasons. The sequence of tasks is not in the form of an uninterrupted sequence. The sequence of stages may be identification, documentation, segregation, review, remedial action and disposal but this is not a continuous sequence. There are breaks and different procedures may apply at each stage depending on what it is that is nonconforming.

There is little merit in having one corrective action procedure when the source of problems that require corrective action is so varied. One Corrective Action Form might be appropriate but its application will be so varied that it is questionable whether one size fits all. Presenting top management with a nonconformity report because it has been detected that the organization charts are not promptly updated following a change, will not motivate them into action. Corrective action forms part of every process rather than being a separate process. It is unreasonable to force all actions aimed at preventing the recurrence of problems through one process. Many problems are prevented from recurring not by following a procedure, but by the designer, the producer, supplier, manager remembering they had a problem last time and doing it differently the next ? i.e. they learn from their mistakes. No forms filled in, no procedures followed ? just people using their initiative ? this is why corrective action is part of every process operation.

Preventive action remains one of the most misunderstood requirements of ISO 9001 because it is mistaken for corrective action but more on this. There is even less justification for one preventive action procedure because the source of potential problems is so varied. Preventive actions are taken in design, in planning, in training and in maintenance under the name of FMEA, Reliability Prediction, Quality Planning, Production Planning, Logistic Planning, Staff Development, Equipment Maintenance ? preventive actions are built into these processes and similar to corrective action are part of every process design.

Five Steps to Implementing ISO 14001:2004

2009-09-19T07:53:00.000-07:00

ISO 14001 provides a logical, common-sense approach for businesses to adopt. To start it is recommended to carry out an environmental review of the business and the Annex to the Standard provides guidance on the approach required. The Standard then requires a management system to be developed that addresses the key environmental issues that were identified by the review as being relevant to the business, through a rational programme of control and continual improvement.
There are five key steps to ISO 14001 EMS implementation, and subsequent operation which are clearly laid out in just three pages of text.
The five key steps are:
1. Environmental Policy
2. Planning
3. Implementation and Operation
4. Checking and Corrective Action
5. Management Review

Step 1. Environmental Policy
The company or organisation must write an environmental policy statement which is relevant to the business activities and approved by top management. Their full commitment is essential if environmental management is to work. The ISO 14001 Standard clearly sets out what to cover in the policy. Often a one page document is sufficient.
Produce a first issue and expect to amend it several times before assessment and registration as knowledge grows in the company.

Step 2. Planning
Plan what the EMS is to address.
Environmental aspects First make lists of the environmental aspects (issues) that are relevant
to the business. The environmental review mentioned earlier should provide most of this information and the Annex to ISO 14001 provides guidance on the format for doing this.
Consider the inputs, outputs and processes/activities of the business in relation to;
a) emissions to air
b) releases to water
c) waste management
d) contamination of land
e) use of raw materials and natural resources
f) other local environmental and community issues

Consider both site (direct) and offsite (ie. indirect) aspects that you control or have influence over (such as suppliers) and in relation to normal operations, shut-down and start-up conditions and reasonably foreseeable and emergencies situations.
A simple written procedure is then required to determine which of the aspects identified are really or probably significant (important) and training needs, outline the key stages of the project and dates that will lead to the target achievement).
Gradually apply environmental management programme thinking to such things as the introduction of new products, new or improved processes and other key activities of the business. In particular, ensure existing projects become environmental management projects
where there is a significant environmental impact involved, so that the EMS becomes company wide. This is a frequent oversight found during ISO 14001 assessments. The EMS must cover the whole business – like a net thrown over the whole business and for example including such things as engineering and maintenance

Step 3. Implementation and Operation
Structure and responsibility
Appoint one or more people, depending on the size of the business, to have authority and responsibility for implementing and maintaining the EMS and provide sufficient resources. (It’s worth monitoring costs carefully and benchmarking these against key consumption figures so
that improvements delivered by the EMS become apparent).
Training, awareness and competence
Implement a procedure to provide environmental training appropriate to identified needs for management, the general workforce, project teams and key plant operators. This can have far reaching benefits on employee motivation. The workforce is usually very supportive of moves to achieve genuine environmental improvement. Every company has its share of cynics but even some of these can be won over with time. Training will vary from a general briefing for the
workforce to detailed environmental auditor training.
Communication
Implement procedures to establish a system of internal and external communication to receive environmental information and respond to it and to circulate new information to people that need to know. This will include: new legislation, information from suppliers, customers and
neighbours and communications both with employees and for employees about progress with the EMS. This process can often generate worthwhile ideas from employees themselves for future
environmental improvements.
Environmental management system documentation The EMS itself needs to be documented with a manual, procedures and work instructions but keep it brief and simple. The Standard
clearly states where procedures are required. Eleven system procedures are required to maintain the EMS, plus operating work instructions but if you already have ISO 9000, this will cover most of six of the procedures required and a quality system can certainly be expanded to cover ISO 14001 as well. Cross reference the EMS manual to other environmental and quality documents to link the EMS and to integrate it with existing business practices.
Operational control
Implement additional operating procedures (work instructions) to control the identified significant (important) aspects of production processes and other activities. Some of these will already exist but may need a ‘bit of polish’. Don’t forget significant aspects that relate to goods and services from suppliers and contractors.
Emergency preparedness and response
Implement procedures to address reasonably foreseeable emergencies and to minimise their impact should they occur. (eg. Fire, major spillages of hazardous materials, explosion risks etc.)

Step 4. Checking and Corrective Action
Monitoring and measurement
Implement procedures to monitor and measure the progress of projects against the targets which have been set, the performance of processes against the written criteria using calibrated equipment (verify monitoring records) and regularly check (audit) the company’s compliance with legislation that has been identified as relevant to your business. The most effective way of doing this is through regular progress meetings.
Nonconformance and corrective and preventive action
Implement procedures to enable appropriate corrective and subsequent preventive action to be taken where breaches of the EMS occur (eg. process control problems, delays in project process, noncompliance with legislation, incidents etc.).
Records
Implement procedures to keep records generated by the environmental management system. The Annex to the Standard suggests those that are likely to be required.
Environmental management system audit
Implement a procedure to carry out audits of each part of the EMS and company activities and operations to verify both compliance with the EMS and with ISO 14001. Audit results must be reported to top management . A typical audit cycle is one year but more critical activities will require auditing more frequently.

Step 5. Management Review
At regular intervals (typically annual), top management must conduct through meetings and record minutes of a review of the EMS, to determine that it is still appropriate and effective or to make changes where necessary. Top management will need to consider audit results, project progress, changing circumstances and the requirement of ISO 14001 for continual improvement, through setting and achieving further environmental targets.

ISO 14001 And The Environment

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The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO’s portfolio – but enviroment-related standardization is far from being a new departure for ISO.
In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.
On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total morethan 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.
They also serve in a number of countries as the technical basis for environmental regulations.
ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in
1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.
ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.
This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.
Today, delegations of business and government experts from 55 countries have participate actively within TC 207,
and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.
This national consensus is derived from a process of consultation with interested parties.
From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.

ISO 14001:2004 Standards Contents

2009-09-19T07:47:00.000-07:00

ISO 14001:2004 Standards
ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.

Assessing the Corporate Impact of ISO 14000 Certification

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Assessing the Corporate Impact of ISO 14000 Certification

The 1990s have indeed been a period of change. This has seen a change from a perspective that
emphasized trade-offs (you can have only one of the following quality) to a paradigm that stresses
simultaneity (you can simultaneously achieve lower costs and higher quality and shorter lead times).
This has also become a period when more and more managers are expected to become increasingly environmentally conscious. Being environmentally responsible is no longer viewed as something that is primarily done for publicity sake or to avoid prosecution. Rather it is seen as a matter of good business.
An indication of the increasing importance of the environment is the recent emergence of the ISO 14000 environmental standard. There are several features that make this new standard noteworthy.
First, it builds on the success of ISO 9000, and its variants (e.g., QS 9000).
Second, ISO 14000 is an international standard. It is hoped that it will replace the numerous and often conflicting standards found in various countries. Third, ISO 14000 shifts attention from the outcome (reduced pollution) to processes. However, being a new standard, the introduction of ISO 14000 has raised a number of questions, namely:
1. What is the status of environmental management systems in most American plants and how are they perceived by management?
2. How are the predispositions of management towards ISO 14000 influenced by factors such as pastexperience with ISO 9000, corporate orientation towards environmental responsibility, industrial factors, importance of international trade to corporate performance and the functional positions of the respondents?
3. To what extent do the respondents see a relationship between ISO 14000 registration and success and improved market, or corporate performance?
4. How effective is ISO 14000 relative to the other alternatives available for improving environmental performance?

These and other questions formed the focus of a recently completed two-stage study into the status of ISO 14000 certification in the United States. The first phase consisted of a large-scale survey (consisting of some 16 pages) that were sent out to managers in various functions across the United States. This phase generated a database of 1,510 respondents. In the second phase, the researchers examined detailed case studies of eight plants shorter lead times, lower costs or higher? experience with ISO 14000. These plants were drawn from five categories:
ISO 14000 not being consider/only do it if mandated;
Assessing suitability of ISO 14000;
Planning for ISO 14000/Pursuing ISO 14000 Certification;
Implementing ISO 14000/Pilot Plants in North America; and,
Successfully certified in ISO 14000.

Implications for the Purchasing Professional
To date, the purchasing professions have played a relatively minor role in the ISO 14000-certification process. For the most part, interest in certification has been confined to within the firm. However, this certification process can and does present the purchasing professional with certain opportunities to improve both environmental and strategic performance not only within the firm but also within the supply chain. The results point out the need for purchasing professionals to take a more active role within the ISO 14000-certification process. They must start looking for and exploiting previously overlooked opportunities.
ISO 14000-certification represents a growth in opportunities.
In short, this study shows that there is much more action than hype about the ISO 14000 environmental standards. The early results are in and the evidence, while not complete, indicates that ISO 14000-certification does work. It does achieve the twin objectives of reduced pollution and improved corporate performance.

Environmental Aspects (ISO 14001:2004, 4.3.1)

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The requirement of 4.3.1 of ISO 14001 is to establish and maintain procedures
1) for identifying the environmental aspects of the organization’s activities, products, and services that it can control and those that it can influence and
2) for determining which of those aspects have or can have a significant impact on the environment. Understanding the requirement of this element of ISO 14001 is central to understanding the concept of an environmental management system.

1 .A single manufacturing facility has potentially hundreds of environmental aspects. How far must it go in identifying its environmental aspects to satisfy the terms of the requirement? ISO 14001 specifies that the organization is to identify those aspects that it can control and those that it can influence and that it must also take into account planned or new developments and new or modified activities, products, and services. These stipulations in the requirements, without actually drawing boundaries on how far the organization must go in identifying environmental aspects, at least establish some categories of aspect that must be considered. Beyond this principle, each organization must identify its aspects comprehensively enough so as to not fail to identify a significant aspect or a legal requirement. An objection to comprehensive identification of aspects is that the organization may become so immersed in aspects identification that it loses sight of the end objective of the procedure, which is to determine significance.
2. Significant impact is not a stand-alone term in ?4.3.1.
It is accompanied by the phrase impact on the environment_ and environment_ is a defined term (see definition of environment, ?3.5). Significant aspects, then, are those environmental aspects that have or can have significant impacts on air, water, land, natural resources, flora, fauna, and humans. The organization determines, using its own criteria, what magnitude of impact on these seven environmental receptors constitutes a significant impact. Whether an aspect is regulated is not intended to be a factor in determining significance.
3. Proper execution of the environmental aspects procedure is important, in part, because it lifts environmental management out of the regulatory compliance mode and into the mode of systematically identifying environmental aspects and impacts and considering their consequences for the environment, irrespective of regulation. The organization that rigorously applies the environmental aspects procedure discovers many opportunities to improve environmental performance that regulation does not address, including:
• Use of energy
• Consumption of materials
• Environmental impacts of employee activities
•Environmental impacts of products and by-products post-manufacture, including distribution, use, reuse, and disposal
• Environmental impacts of services
• Unregulated waste streams such as carbon dioxide
Aspects vs. Impacts – Environmental aspects and environmental impacts differ by definition from one another in that an aspect is an element of an organization’s activities, products or services that can interact (emphasis added) with the environment_ while an impact is any change (emphasis added) to the environment_ resulting from an organization’s environmental aspects._ An aspect, then, is a precursor to an impact and an impact occurs when the aspect interacts with and changes the environment.
When identifying its aspects and impacts, the organization may find that there are more than one potential impacts associated with any given aspect. For example, an environmental aspect of a coal-fired power generation facility is stack emissions containing sulfur dioxide, nitrogen oxides, mercury, and carbon. These emissions change the environment and become impacts by contaminating plants, soil, and surface waters; contributing to the formation of ground-level ozone; causing or exacerbating heart and lung disease in humans; entering the aquatic food chain and impairing reproductive, immune, and endocrine systems; and contributing to the increase in atmospheric carbon dioxide leading to global warming. One aspect, stack emissions, then can generate at least five impacts.
Other organizations, applying benefit/cost analyses to their corrective actions, may discover that creation of a beneficial impact provides a greater environmental benefit than elimination of an adverse impact.
The introduction of the beneficial environmental impact concept into the ISO 14001 Terms and Definitions suggests that it was considered by some of the ISO 14001:1996 drafters as a placeholder for the future possibility of offsetting adverse impacts with beneficial and, on balance, achieving an environmentally neutral organization.
Control and Influence – The environmental aspects procedure requires the organization to identify those environmental aspects that it can control and those that it can influence._ Circumstances where control and influence are considered separately can occur where the environmental aspects of products or services are concerned. Some examples illustrate the case:
1. No control, no influence – When an organization manufactures a product, such as lumber, and sells it to a customer that can use the product in any way that it wishes, the organization has no control over the environmental aspects of the product’s use. The customer could use the product benignly as in the manufacture of a table or to damage the environment by burning the lumber and releasing its carbon into the atmosphere. In this case, the organization would not be expected to have either control or influence over the environmental aspects of the product.
2. Control, no influence – When an organization’s environmental aspect is the use of electric power generated from coal, it may be able to control its use of electric power by using less, by buying from a different, less environmentally damaging source, or by generating its own power. Rarely, however, does the organization have influence over the power generator to an extent that it could influence it to reduce the environmental impacts of power production.
3. Influence, no control – When an organization manufactures a product, such as an automobile, which is sold to the customer without restrictions on its use, the organization may be said to have no control over the environmental aspects of the product’s use. The organization may, however, be able to assert influence with the inclusion of owner’s manuals containing instructions for low impact use of the product.
4. Control and influence – When an organization buys a product built to its specifications, it has control over the products’ environmental aspects in the sense that it can determine the environmental aspects of the product. In this case, control also includes influence.
Significant Impacts – ISO 14001 does not provide guidance as to what constitutes a significant impact on the environment_, leaving that determination to the organization.
Many organizations ignore the qualifying phrase, impact on the environment_, and add additional criteria to what they determine to be significant impacts. For example, many organizations decide that aspects that are the subject of regulation, irrespective of impact to the environment, or that can cause damage to business reputation, are significant. Legal requirements, however, are identified in ?4.3.2 and legal requirements and business requirements are specifically considered when the organization establishes its objectives and targets (?4.3.3). Adding criteria that are not relevant to impact on the environment in the determination of significance distorts the outcome of procedures for environmental aspects and objectives and targets by giving these criteria undue weight in the determination of significance. For example, an environmental aspect that is significant only because its disclosure might affect the organization’s reputation is best dealt with in the Public Relations Department rather than as an environmental aspect.
Determination of significance is a yes or no question, not a determination of relative value. It is possible, therefore, that the execution of the environmental aspects procedure will result in the determination that the organization has no significant aspects. While the organization may elect to rank its aspects from most significant to least significant, that does not necessarily mean that any rise to the level of significant impact on the environment.
Where the impact occurs can be material to determination of significance. For example, a coal-fired power plant’s air emissions can interact with the environment; these emissions are clearly environmental aspects. Whether they significantly impact the environment may depend upon where the interaction with the environment occurs.
Part of the importance of establishing significance lies in the fact that the potentially significant environmental impacts become a focus of Objectives and Targets (?4.3.3), Competence (?4.4.2), Operational Controls (?4.4.6), and Monitoring and Measurement (?4.5.1) requirements.
An organization that determines that aspects are significant because of regulation or business reputation increases the amount of work it must do in these areas.
ISO 14001 does not require the organization to establish objectives and targets for each significant environmental aspect. On the one hand, the absence of a requirement to set objectives and targets for all significant aspects gives organizations latitude to conform to the requirements of ISO 14001 while not presently dealing, for example, with the significant environmental aspects of products. On the other, a requirement to establish objectives and targets for all identified significant aspects could easily overwhelm an organization having many significant aspects. Without this latitude, organizations might choose to ignore the existence of significant aspects that they believe are insurmountable or even decide not to implement ISO 14001. As it is, many organizations choose to deny the existence of significant aspects about which they feel they can do nothing.

Emergency Preparedness and Response In ISO 14001

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Emergency Preparedness and Response In ISO 14001
Under the Emergency Preparedness and Response requirement of ISO 14001:2004 (§4.4.7), the organization is required to establish procedures for identifying the potential for and responding to emergency situations and accidents that can have an impact on the environment.
Identification of Potential Emergency and Accident Situations – Experience indicates that organizations infrequently have a preexisting procedure for identifying potential emergency and accident situations.The norm is to establish emergency and accident responses for a variety of emergency and accident situations irrespective of the potential for their occurrence. But ISO 14001 is specific about requiring a procedure to identify the potential for emergency situations and accidents. Adhering to the requirement of the procedure is a valuable exercise that helps organizations identify weaknesses in their own emergency planning and to plan for that which is most likely to occur.Because many environmental impacts of an emergency or accident situation are secondary in nature, it appears that all potential emergency or accident situations need to be identified before a determination of environmental impacts can be made. An organization that attempts to identify potential emergency or accident situations based on a review of its environmental aspects would likely miss the environmental impact potential of, say, an automobile accident.
There are five steps implied by the emergency preparedness and response requirement:
1) Identify the potential for emergency situations and accidents of all kinds;2) Paying particular attention to the potential environmental impacts of accidents and emergency situations, identify how the organization can prevent and mitigate associated adverse environmental impacts;3) Determine how the organization and its employees should respond to emergency situations and accidents;4) Periodically simulate emergency situations to test response capabilities; and,5) Review and revise procedures based on experience derived from actual and simulated emergency situations and accidents.
Accident and Emergency Situation Identification – In order to identify potential for and responding to emergency situations and accidents, the organization should develop a procedure for systematically identifying accident and emergency situations, evaluating their probability of occurrence, their likely consequences, and their severity.Organizations often engage risk management specialists to assist in the identification of potential emergency or accident situations that could lead to human injury, environmental damage, or economic loss. While many checklists are available to facilitate this kind of evaluation, there is virtually no substitute for physical evaluation of facilities by knowledgeable personnel, whether employees or outside professionals.
Emergency Response Procedures – The organization is required to develop procedures for responding to emergency situations and accidents when they occur. Typically, response procedures include identifying public emergency response agencies and their capabilities, identifying individuals within the organization who are trained and able to provide assistance in emergencies, establishing an emergency communications network, and providing emergency lighting, signage, and equipment. Because Emergency Response Procedures are based on identified potential emergency situations and accidents specific to the organization, the emergency response plan will be unique for each organization.
Periodic Testing – The value of conducting emergency response exercises lies not only with simulating situations that could occur but also in identifying flaws in the response plan. Practice drills can be the most effective test of the system to give employees, emergency response personnel, and management the opportunity to walk through the plan and gain familiarity with its procedures. While a full-dress response exercise is valuable, testing of procedures can be effectively done on much smaller scales and still provide the benefits of testing. Above all, the organization should not let the impracticality of a full-dress exercise keep it from testing sub elements of the emergency response plan.
Review and Revise – ISO 14001 calls for continual improvement of the EMS. Periodically reviewing and revising emergency response plans based on the experience gained from the occurrence of emergency situations or accidents or in testing response plans is an example of continual improvement.
Written Response Plans – Many written emergency response plans are too cumbersome to be of value in an emergency situation – their value depends entirely upon previous training of persons who will be called upon to execute them. Yet, many organizations fail to provide the emergency response training necessary to make the plans functional.Keeping in mind that even the simplest, most direct emergency response plan requires training for effective implementation, an alternative for organizations to consider is establishment of abbreviated, readily available Immediate Response Directions established for each kind of potential emergency situation or accident. Such an emergency response plan might consist of a laminated card prepared for each potential emergency situation or accident and providing specific responsibilities and associated actions for employees and visitors, supervisors, emergency coordinators, and emergency director

Nonconformity, Corrective Action and Preventive Action in ISO 14001 EMS

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The intent of §4.5.3 is that the organization put in place procedures for 1) identifying actual and potential nonconformities to EMS requirements, 2) taking appropriate corrective or preventive action, and 3) reviewing the effectiveness of corrective or preventive actions taken.The nonconformity requirement of ISO 14001:1996 was a passive requirement in that it was only triggered when a nonconformity came to the attention of the organization through one of the other EMS procedures, such as the EMS audit or management review. ISO 14001:2004, however, requires that the organization establish and maintain procedures to identify actual or potential nonconformities, determine their causes, take action to avoid recurrence or occurrence, record results, and review effectiveness of corrective or preventive actions.
How the organization goes about identifying actual or potential nonconformities is up to it to determine. From the standpoint of registration auditors, it would seem that they would want to see a specific procedure requiring members of the organization to conduct some kind of periodic checklist driven, walk-through inspection for nonconformities. In addition, the procedure should allow for submission of nonconformities by any member of the organization. Actual nonconformities are usually fairly evident and relatively easy to investigate because there is a tangible occurrence with which to deal. The organization should also want to evaluate minor instances of nonconformity that, while not significant in and of themselves, if they occurred under different circumstances, could lead to a significant deviation from the EMS. Such “near misses” could be identified by the occurrence of a sudden, unexpected event, a failure to achieve an objective or target, or a deviation from the Environmental Policy.Potential nonconformities are more difficult to identify and correct. Here, application of Failure Mode and Effects Analysis would be appropriate for organizations having that capability.
When investigating nonconformities, organizations should focus on identifying underlying root causes, not just the immediate manifestation of the problem. If a chemical storage drum leaks, the organization should take action, first, to mitigate the damage and, then, to determine why the leak occurred; e.g., improper or negligent handling, mechanical failure, or lack of a leak detection system. Corrective or preventive actions should then focus on eliminating the cause through training, communication of procedures, use of leak-resistant drums, or installation of a leak detection system.
Other ISO 14001 sections, principally Emergency Preparedness and Response, Internal Audit, and Management Review, are tools that the organization implements in order to help identify instances of actual or potential nonconformity. The underlying principle of these sections is that the identification of nonconformities should be made by the organization through diligent application of these tools, not from the occurrence of an environmental event, a customer or community complaint, or investigation by a regulatory authority. While §4.5.3 does not specifically mention disciplinary action, in many cases disciplinary action or the threat of disciplinary action is appropriate to prevention of future nonconformities. Many organizations have written codes of conduct that give employees notice that deviations from the codes will not be tolerated and that prescribed penalties can result for infractions. These codes can be expanded to include penalties for deviations from the EMS. If so, penalties should be commensurate with the violation itself and should acknowledge the nature of the environmental damage, the degree of negligence, prior conduct, and the forthrightness of the employee being disciplined. Any such code and its remedies should be administered fairly and consistently and should have as its objective correction and prevention of EMS nonconformities, not punishment of employees.Finally, identification, investigation, and correction of nonconformities leads to the need to revise documented procedures.

Quality Management: understanding Quality Management

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Quality Management may be defined as the process through which organizations apply statistical process control mechanisms in order to improve the quality and standards of goods and services that are manufactured. Closely related to Quality Management is tqm, also known as total quality management. This is basically a management strategy that is applied in businesses in order to create awareness of high quality in most organizational processes. Quality Management features three main components including quality assurance, quality improvement and quality control. Quality management is focused not only on the quality of products and services but also on continuous improvement of quality standards.
Most methods that are now being used for Quality Management, quality system and quality manufacturing system take into consideration the need for high quality as an essential attribute in services and products that are manufactured by companies and organizations. Quality Management usually involves the successful improvement of quality of services and products. This is usually done through quality training processes where one can also acquire lessons on quality process and process management. One tool that is used for ensuring auditing quality in Quality Management is the MasterControlQAAD(TM) software. Besides using tools to carry out Quality Management successfully, one can also consider applying project management. This will help ensure continuous quality improvement.
The other way through which organizations can improve quality of process and service output is by using six sigma. This is basically a business management strategy that helps identify and remove defects and variations in the manufacturing process. It also helps guarantee Quality Management. It works by using a set of high quality business management and overall management methods to ensure quality and guarantee Quality Management. Most products and services to which Quality Management is applied are certified with iso certificates. Some of the iso certificates that guarantee that a product or service has undertaken Quality Management, change management and process improvement is iso 9001.
iso 9001 and iso 14001:2004 set down specific guidelines for environmental management systems and Quality Management. Other guidelines can be found in other generic process management philosophies such as the lean management that follows iso 9000 quality improvement standards aimed at guaranteeing total quality to its quality systems. The other mode through which organizations guarantee Quality Management is by use of a quality plan that meets iso 14000 and iso 14001 iso certification requirements. The other iso certification that guarantees product quality in Quality Management include iso 9001 2000.
In order to meet supplier quality in Quality Management systems, there are several iso training sessions that are offered. These meet iso standards. An organization that is in need of Quality Management for its products and services may also consider using a quality manual for its day to day Quality Management plans. Such a manual will usually have guidelines for iso quality. However, when applying the guidelines in the manual, regard must be had to quality audit measures aimed at guaranteeing Quality Management for the organization. Quality Management also involves knowledge of as9100 and iso 13485 that are commonly applicable in supplier management.
Quality Management programs that are iso certified help offer quality policy to existing iso 9001 certifications and quality management system that meet iso 9000 and ts16949 requirements. Quality companies that are aimed at ensuring Quality Management for the products and services that they manufacture also use quality management software that guarantees managing quality. In order to enhance Quality Management, the software guarantees quality procedures through its high rate of functionality. Besides such software, an organization can adopt quality assurance training and also offer quality consulting to its members in order to guarantee Quality Management to its products and services.
There are also several quality project management plans, which meet iso standards such as iso 9002 that are available today. Such plans are usually developed with a view to developing flexible, affordable and scalable management solutions to companies that seek to uphold Quality Management for their products and services. Such plans feature quality management systems that offer quality control management and quality assurance management through quality a management plan. Other quality objectives that can be obtained through iso 9001 training thus meeting iso 9000 certification use project management skills to improve Quality Management for the manufactured products and services.

ISO 14001 ENVIRONMENTAL POLICY

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The Environmental Policy statement required under ISO 14001 is the keystone upon which the entire environmental management system is constructed. It is not a public relations document that is posted on the conference room wall or handed out to potentially impacted stakeholder groups. The Environmental Policy is the central focus of the environmental management system. It must contain and clearly communicate the following for the organization:
· Mission and core values with respect to the environment, and· Commitments to control and improve environmental performance withrespect to significant environmental aspects of the organization’s products,services and/or activities.
The commitment to control and improve environmental performance with respect to the environment leads to the development of Environmental Objectives and Targets (4.3.3).Once those items have been delineated the rest of the environmental management system is devoted to accomplishing the objectives and targets which fulfil the EnvironmentalPolicy. ISO 14001 requires that a coherent and cogent Environmental Policy be developed and implemented.

ISO 14001 ENVIRONMENTAL MANAGEMENT PROGRAMME

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In order to be in conformance with this provision of ISO 14001 an organization must be able to demonstrate four specific points. First, it must demonstrate that it has established management programs for achieving the Environmental Objectives and Targets. Second, it must demonstrate that it has assigned responsibility at each appropriate level of the organization in order to achieve the Environmental Objectives and Targets. Third, the organization must specify the time frames and the mechanisms needed to achieve the Environmental Objectives and Targets. Fourth, under the principle of continual improvement, the organization must modify its environmental management program for “changed” conditions if they occur.
In general a program designed to achieve the desired endpoint must support every objective and subsequent target. Responsibility for management and leadership must also be assigned where it is necessary and appropriate to complete the task. Timeframes should be clearly outlined within the management program. If additional technology, equipment, staffing, etc. are needed to accomplish the tasks, then these “mechanisms” must be supplied. Continual improvement is referenced within this section of ISO 14001 in order to reinforce its importance within the standard.

ISO 14001 ENVIRONMENTAL MANAGEMENT SYSTEM AUDIT

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In order to be in conformance with this provision of ISO 14001 an organization must be able to answer the overall question: “How does the organization conduct environmental audits of the EMS?”. In order to answer that question four specific tasks must be addressed under the Management System Audit section of the standard.
First, the organization must develop a program and related procedures that define an audit plan of the environmental management system. In addition the program must define frequency of the audit process. Second, the procedures must specify the methodology of the audit process, including the qualifications of the auditors. Third, the audit reports must be submitted to top management. Fourth, the audit reports must provide recommendations directed at correcting any reported nonconformance that was discovered in the audit process.
The audit process discussed in this section of the standard is directed at internal audits. The standard is silent on the frequency issue. Generally accepted practice with a mature ISO 14001 system is a total audit of the system once a year. In the implementation phase of an environmental management system a more frequent audit process might be appropriate. In addition any part of the environmental management system that has been previously determined to be in nonconformance should be audited with an increased frequency. The methodology of the audit process required by the standard requires two distinct steps:
A. determine whether the environmental management system conforms to the requirements of ISO 14001, andB. that the system has been managed as described in the Environmental Policy statement, the Environmental Objectives and Targets, and the related work descriptions and procedures.
It is critical that an audit report that relates a nonconformance be forwarded to top management promptly. The internal audit staff must be competent with respect to the requirements of ISO 14001.

ISO 14001 ENVIRONMENTAL ASPECTS

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The key to a successful registration for conformance with ISO 14001 is to accurately determine the organization’s Environmental Aspects and Impacts, arrive at which are the most significant and therefore require the most attention. Two definitions should be reviewed at this point.
Environmental AspectElement of an organization’s activities, products or services that can interact with the environment.
NOTE — A significant environmental aspect is an environmental aspect that has or can have a significant environmental impact.”
and
Environmental ImpactAny change to the environment, whether adverse or beneficial, wholly or partially resulting from an organization’s activities, products or services.”
There are three distinct requirements contained within this section of ISO 14001.
First, the organization shall identify the environmental aspects of its activities, products and/or services. In other words the organization must understand how it interacts with the environment.
Second, the organization shall identify the specific environmental aspects that can be controlled, and over which it can be expected to have influence.
Third, arrive at a list of significant environmental aspects based upon the individual environmental impact of each environmental aspect. The importance of this third step cannot be underestimated.
The final list of significant environmental aspects will provide the basis for the Environmental Policy statement, and the Environmental Objective(s) and Targets. In other words the list of significant environmental aspects drives the entire content and scope of the operational portion of the environmental management system.

Understanding the ISO 14001 Standard

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ISO 14001 is an international voluntary standard that specifies the minimum elements for an environmental management system. It was published in 1996 by the International Organization for Standardization and is being taken up by organizations throughout the world at varying speeds.
The above is accepted as true by most people who are aware of the standard. Beyond these simple facts, however, there are many misconceptions about ISO 14001. For instance:
ISO 14001 will be a requirement for all companies.As with ISO 9000, conformance to ISO 14001 may become a condition of doing business in certain countries, regions or markets. This process already has begun in some industrial sectors, such as the automotive and electronics markets. However, there are still a tremendous number of companies in business today that do not conform to ISO 9000, even though that standard is now 13 years old. Thus it is too early to tell how widely ISO 14001 will be required in the future.
Implementing ISO 14001 means getting a registration.Many suppliers choose to demonstrate conformance to ISO 14001 through third-party certification. Some customers may require this. However, the standard itself considers a company’s self-declaration of conformance as an acceptable alternative. Further, some companies simply use the ISO 14001 model for internal purposes as a means to enhance their environmental performance.
ISO 14001 is just paperwork and won’t really help my company.ISO 14001 is like many things in life – you get out of it what you put into it. The way a company implements the standard determines what benefits it receives. Many companies that have implemented ISO 14001 report a variety of benefits, including improved environmental performance, greater operating efficiency, cost reduction, improved employee awareness and enhanced public image, among others.
Implementing ISO 14001 means throwing out our current environmental programs.ISO 14001 criteria specify “what to do,” not “how to do it.” Implementation approaches vary widely. There is no reason to think that your existing approach to environmental management must be put aside to satisfy ISO 14001.

ISO 14001:2004 Document Control System

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Documents required by the environmental management system and by this international standard shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements given in 4.5.4 (Control of Records).
The organization shall establish, implement, and maintain a procedure(s) to
a) approve documents for adequacy prior to issue;
b) review and update as necessary and re-approve documents;
c) ensure that changes and the current revision status of documents are identified;
d) ensure that relevant versions of applicable documents are available at points of use;
e) ensure that documents remain legible and readily identifiable;
f) ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the environmental management system are identified and their distribution controlled; and
g) prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose. [ISO 14001, 4.4.5]

THE REQUIREMENTS OF ISO 14001:2004 WITH RESPECT TO LEGAL COMPLIANCE

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ISO 14001:2004 requires an organization to make a “commitment” in its environmental policy to comply with applicable legal requirements that relate to its environmental aspects. The organization shall establish, implement and maintain a procedure(s) for periodically evaluating compliance with applicable legal requirements that is consistent with realising this commitment.
The specific clauses of ISO 14001:2004, which are most important with respect to legal compliance are the following EMS elements:
1) public environmental policy commitment to legal compliance (sub-clause 4.2);
2) identification and having access to applicable legal requirements and other requirements related to its environmental aspects (sub-clause 4.3.2 a));
3) how those legal requirements apply to the organisation’s environmental aspects (sub-clause 4.3.2 b));
4) objectives/targets/programs (sub-clause 4.3.3)
5) how legal obligations are routinely managed and monitored (sub-clauses 4.4.6 and 4.5.1);
6) evaluation of legal compliance (sub-clause 4.5.2);
7) corrective and preventive actions where necessary (sub-clause 4.5.3);
8) internal audit (sub-clause 4.5.5); and
9) management review (sub-clause 4.6).

Implementing ISO 14001

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ISO 14001 is an internationally recognised standard that provides a framework for a strategic approach to corporate environmental management. This standard gives organisations the means to identify and control their environmental impacts, improve performance and achieve their objectives and targets. The standard is independently audited, giving it great strength and integrity.
Due to its widespread adoption (e.g. Barclays, Credit Suisse and UBS in the financial sector), it now acts as a common reference for communication about environmental issues. ISO 14001 provides assurance to stakeholders on environmental claims and helps organisations meet requirements laid down by clients and investors.
Adoption of ISO 14001 is being driven by stakeholder concerns as well as the significant benefits on offer to adopters. Few companies are now exempt from government, client and investor demands for accountability and improved environmental performance. With brand and reputation on the line, it is a risky strategy to ignore these concerns.
However, choosing how to act is not a straightforward decision. Companies that rushed to announce their green credentials without independent verification and transparency fell foul of greenwash accusations and suffered perhaps more damage to their reputation than had they not acted in the first place. In response to this, many companies are now choosing to implement internationally recognised and independently audited environmental management systems such as ISO 14001.
The benefits of implementing ISO 14001 are extensive:
It immediately enhances corporate reputation and sends a clear signal of commitment to corporate responsibility. Accusations of greenwash are prevented by the transparent and robust approach of the standard.
Proactive environmental management increases attractiveness to investors, especially for Socially Responsible Investment (SRI), an area already accounting for £9 billion investment per year in the UK alone.
ISO 14001 accreditation may also bring financial benefits through increased market share. Firms can differentiate themselves from competitors as responsible companies as well as securing the rewards of first mover advantage in new markets. In addition, many buyers are now implementing sustainable procurement codes and stipulating conditions in Requests for Information (RFIs) where suppliers are required to have environmental credentials. Gaining ISO 14001 accreditation ensures access to environmentally demanding but high reward markets.
Financial benefits are not limited to increased investment and sales. Implementation of an EMS may produce significant cost savings that actually negate the initial outlay. With energy and waste prices rising sharply, environmental responsibility can produce a win:win opportunity.
Perhaps the most significant benefit for many will be the positive effect on attracting and retaining staff. With intense competition for the best staff, corporate responsibility is becoming a key criterion against which employers are judged.
Finally, responsible environmental management is quickly becoming a necessary condition for business, a socially accepted norm of behaviour. Those who fail to follow these norms risk damage to their reputation and the possibility of their social licence to operate being revoked.
A standard as thorough and robust as ISO 14001 has an equally thorough implementation process with extensive requirements for procedures and auditable document trails. Implementation follows the Plan-Do-Check-Review cycle and key required procedures are detailed in the diagram below. Implementation will entail the creation of at least 20 procedures and supporting documents. The procedures are all company-specific and must be tailored to suit individual operations. It is this level of detail that gives the standard such strength and integrity.

The ISO 14000 Challenge

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The building blocks of an environmental management system is an understanding of aspects and impacts.
Implementing ISO 14001 begins with identifying how an organisation’s business activities impact on the environment.
Many organisations believe they are already aware of the significant aspects and impacts of their operations.
The process of implementing ISO 14001 may uncover significant impacts not previously identified and allows for a consistent approach to analysis.
Generally this analysis is done department by department or centre by centre.
It is best if it is a team approach that involves the employees who do the activity. An employee’s
familiarity with a task is essential for both the identification of the environmental impacts of business activities and the determination or implementation of control measures.
An aspect is any element of an organisation’s activities, products or services that can interact with the environment.
An impact is the change caused to the environment.
Impacts may occur during normal and abnormal operating conditions, such as accidents and
emergencies.
Aspects can often be isolated by analysing the inputs and outputs of an activity.
EVALUATION OF IMPACTS
Once the impacts have been determined they have to be evaluated.
Criteria for evaluation include environmental concerns such as the severity of the impact, and business concerns such as potential regulatory and legal exposure, the probability of the impact occurring, the cost of changing the impact and effect on public image.
This type of evaluation highlights the significant impacts. These, in turn, determine the significant aspects. Once the significant aspects have been determined, targets and objectives can be set.

What Is an Environment Management System (EMS) ?

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An EMS can be described as a program of continuous environmental improvement that follows a defined sequence of steps drawn from established project management practice and routinely applied in business
management. In simple terms these steps are as follows:
• Review the environmental consequences of the operations.
• Define a set of policies and objectives for environmental performance.
• Establish an action plan to achieve the objectives.
• Monitor performance against these objectives.
• Report the results appropriately.
• Review the system and the outcomes and strive for continuous improvement.
Not every system will present these steps in exactly the same way, but the basic principles are clear and easily understandable.
The ISO 14000 series is a series of standards for different aspects of environmental management. A number of these standards relating to environmental management systems have been adopted formally by
the members of the ISO, while others are in different stages of preparation.
The standards that have been adopted are (as of early 1997):
ISO 14001-1996 Environmental management systems:
specification with guidance for use
ISO 14004-1996 Environmental management systems:
general guidelines on principles, systems, and supporting techniques
ISO 14010-1996 Guidelines for environmental auditing:
general principles of environmental auditing
ISO 14011-1996 Guidelines for environmental auditing:
audit procedures; auditing of environmental management systems.
ISO 14012-1996 Guidelines for environmental auditing:
qualification criteria for environmental auditors Standards currently available as draft international standards:
ISO 14021 Environmental labels and declarations:
self-declaration environmental claims; guidelines and definition and usage of terms.
ISO 14040 Environmental management: life cycle assessment; principles and framework
ISO 14050 Environmental management: vocabulary More than half a dozen others in this series have been drafted and are under discussion.

ISO 14001 STANDARD

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ISO 14001 is in fact a series of international standards on environmental management. It provides a framework for the development of an [url=htttp://www.iso9001store.com/]environmental management system[/url] and the supporting audit programme.
The ISO 14001 series emerged primarily as a result of the Uruguay round of the GATT negotiations and the Rio Summit on the Environment held in 1992. While GATT concentrates on the need to reduce non-tariff barriers to trade, the Rio Summit generated a commitment to protection of the environment across the world.
After the rapid acceptance of ISO 9000, and the increase of environmental standards around the world, the International Standards Organisation (ISO) assessed the need for international environmental management standards. They formed the Strategic Advisory Group on the Environment (SAGE) in 1991, to consider whether such standards could serve to:
Promote a common approach to environmental management similar to quality management;Enhance organizations’ ability to attain and measure improvements in environmental performance; andFacilitate trade and remove trade barriers.In 1992, SAGE’s recommendations created a new committee, TC 207, for international environmental management standards. This committee and its sub-committees included representatives from industry, standards organizations, government and environmental organizations from many countries. What developed was a series of ISO14000 standards designed to cover:
-environmental management systems-environmental auditing-environmental performance evaluation-environmental labelling-life-cycle assessment-environmental aspects in product standards
ISO 14001 was first published as a standard in 1996 and it specifies the actual requirements for an environmental management system. It applies to those environmental aspects over which an organization has control and where it can be expected to have an influence.
ISO 14001 is often seen as the corner-stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System and is the only ISO 14000 standard against which it is currently possible to be certified by an external certification body. However, it does not in itself state specific environmental performance criteria.

IS0 14001 HISTORICAL DEVELOPMENT

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Firstly ISO 14000 environment system standards was prepared in June of 1992 year in Rio at world apex and this standard brooks decisions of this world apex and Rio contract principles. After 1 year, ISO established one technique committee which is yielded by 50 different country representatives to prepare international environment management system in 1993 year. ISO 14001 environment management system standard was issued in September of 1996 year with works of this committee. ISO 14001 standard is used as voluntary now but ISO 14001 will be burden by coercions of societies, international organizations, states in the future. Levels which environment management system passed are the following briefly:
= Europe community countries issued I action plan in 1973 year (to practice protecting preventions of environment )= BS 7750 Standard in 1992= Rio Declaration in 1992 year= ISO/TC 207. Environmental management technique committee was established in 1993 year to develop ISO 14000 family standards= TS 9719 standard (environment management system – General features) in 1994 year= ISO 14001 standard in 1996 year= ISO 14001 current version in April of 2005 Nisan 2005
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How ISO 14000 works

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ISO 14001:2004 does not specify levels of environmental performance. If it specified levels of environmental performance, they would have to be specific to each business activity and this would require a specific EMS standard for each business. That is not the intention.
ISO has many other standards dealing with specific environmental issues. The intention of ISO 14001:2004 is to provide a framework for a holistic, strategic approach to the organization’s environmental policy, plans and actions.
ISO 14001:2004 gives the generic requirements for an environmental management system. The underlying philosophy is that whatever the organization’s activity, the requirements of an effective EMS are the same.
This has the effect of establishing a common reference for communicating about environmental management issues between organizations and their customers, regulators, the public and other stakeholders.
Because ISO 14001:2004 does not lay down levels of environmental performance, the standard can to be implemented by a wide variety of organizations, whatever their current level of environmental maturity. However, a commitment to compliance with applicable environmental legislation and regulations is required, along with a commitment to continual improvement – for which the EMS provides the framework.

What is ISO 14000?

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ISO 14000 is a series of international standards that have been developed to incorporate environmental aspects into business operations and product standards. ISO 14001 is a specific standard in the series for a management system that incorporates a set of interrelated elements designed to minimize an organization’s impact on the environment. Similar to the ISO 9001 Quality Management System (QMS), ISO 14001 defines the implementation of an Environmental Management System (EMS). In addition, ISO14001 incorporates the QMS ISO 9001 management system philosophy, terminology, and requirement structure, providing system compatibility.
What Does ISO 14001 Require?
Originally issued in 1996 and later revised in 2004, the ISO 14001 EMS standard is intended to address the identification, evaluation, and continual improvement of an organization’s activities, products, or services that interact with the environment. The ISO 14001 methodology is a systematic approach for continually improving environmental management through identification and evaluation of aspects and impacts, development of objectives and measurable targets, implementation of programs, and on-going monitoring and review.

Emergency Preparedness and Response In ISO 14001

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