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.
Wednesday, September 30, 2009
Quality Planning
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.
ESTABLISHING THE INITIAL STATE OF THE QMS For SME
Establishing The Initial State of The ISO 9001 QMS For SME
The implementation of an ISO 9001 conformant system must recognize that it is but a step in a long-term development of a continually improving QMS. Unfortunately, it is often the case that ISO 9001 is taken as a means to an end, where the implementation of a QMS is not the primary objective, rather certification is. As a result, SMEs may end up with stacks of documentation waiting to be processed that adds no value, but cost.
According to the requirements of ISO 9001, an organization must develop only six documented procedures: (1) control of documents, (2) control of quality records, (3) internal audits, (4) control of non-conformities, (5) corrective action, and (6) preventative action. A quality manual and several records are also required. The development of other procedures, work instructions, and
other documents is largely at the discretion of the organization. From the very beginning of the process, it is therefore essential that SMEs establish a balanced view between a short-term focus (marketing/sales) and a long-term focus (achieving company-wide quality awareness through TQM). ISO documentation should be considered as an enabler along that way and SMEs must guard against the creation of unnecessary documentation.
However, even when such a view is adopted, many SMEs struggle to move from their initial state to a fully functional ISO 9001 QMS. Over the last several years, we have been involved in ISO 9001 implementation projects in seven different SMEs. The SMEs have ranged in size from approximately 20 employees to 500 employees. The SMEs have been drawn from a variety of sectors in Virginia, including manufacturing, distribution, and services. Based on our experience, we developed a schematic of initial states of an organization in terms of the existence and functionality of the ISO 9001 QMS . Throughout this paper, existence is equated with the documentation required by the standard while functionality is equated with an effectively operated QMS that leads to increased customer satisfaction and continuous improvement of business results.
A successful QMS must be fully functional and appropriately documented. With that in mind, there are four main states in which SMEs can be located in the beginning of the implementation process:
1. Complete Death: No documentation, no functioning.
This is the state in which there is no indication of the existence and functionality of the QMS. No documentation exists and no processes are in place to help ensure the quality of the product.
Relatively few companies will find themselves in this situation.
2. Informally Alive: No documentation, some level of functioning.
Many SMEs exhibit an organic structure characterized by an absence of standardization and the prevalence of loose and informal working relationships. SMEs operating in this state are more likely to rely on people rather than a system. In such situations, key personnel may resist documentation for two key reasons “(1) documentation is considered a waste of time and (2) documentation of processes and procedures makes the individual less dependable” [2]. SMEs in this state perform some or all of the processes required by ISO 9001 and the QMS may function fairly well. However, they are not willing and ready to document those processes unless there is a cultural change lead by top management.
3. Formally Death: Some level of documentation, no functioning.
SMEs categorized in this state have documented processes and procedures at some degree, however, the documents are generally not followed and do not necessarily reflect the actual manner in which the organization undertakes its operations and management. This situation highlights the fact that the mere existence of documentation does not necessarily lead to a functional QMS. Moreover, such a situation may help perpetuate the view that ISO 9001 is a way for SMEs to market their products and services but that implementation of the standard requires stacks of documents that offer no value.
4. Formally Alive: Some level of documentation, some level of functioning.
Each SME considered in this state, achieves a unique combination of the existence and functionality of processes and procedures that may or may not be required by ISO 9001. This situation is closest to the desired state of full functionality (100%) of the ISO 9001 QMS and full documentation (100%) of this functionality.
The implementation of an ISO 9001 conformant system must recognize that it is but a step in a long-term development of a continually improving QMS. Unfortunately, it is often the case that ISO 9001 is taken as a means to an end, where the implementation of a QMS is not the primary objective, rather certification is. As a result, SMEs may end up with stacks of documentation waiting to be processed that adds no value, but cost.
According to the requirements of ISO 9001, an organization must develop only six documented procedures: (1) control of documents, (2) control of quality records, (3) internal audits, (4) control of non-conformities, (5) corrective action, and (6) preventative action. A quality manual and several records are also required. The development of other procedures, work instructions, and
other documents is largely at the discretion of the organization. From the very beginning of the process, it is therefore essential that SMEs establish a balanced view between a short-term focus (marketing/sales) and a long-term focus (achieving company-wide quality awareness through TQM). ISO documentation should be considered as an enabler along that way and SMEs must guard against the creation of unnecessary documentation.
However, even when such a view is adopted, many SMEs struggle to move from their initial state to a fully functional ISO 9001 QMS. Over the last several years, we have been involved in ISO 9001 implementation projects in seven different SMEs. The SMEs have ranged in size from approximately 20 employees to 500 employees. The SMEs have been drawn from a variety of sectors in Virginia, including manufacturing, distribution, and services. Based on our experience, we developed a schematic of initial states of an organization in terms of the existence and functionality of the ISO 9001 QMS . Throughout this paper, existence is equated with the documentation required by the standard while functionality is equated with an effectively operated QMS that leads to increased customer satisfaction and continuous improvement of business results.
A successful QMS must be fully functional and appropriately documented. With that in mind, there are four main states in which SMEs can be located in the beginning of the implementation process:
1. Complete Death: No documentation, no functioning.
This is the state in which there is no indication of the existence and functionality of the QMS. No documentation exists and no processes are in place to help ensure the quality of the product.
Relatively few companies will find themselves in this situation.
2. Informally Alive: No documentation, some level of functioning.
Many SMEs exhibit an organic structure characterized by an absence of standardization and the prevalence of loose and informal working relationships. SMEs operating in this state are more likely to rely on people rather than a system. In such situations, key personnel may resist documentation for two key reasons “(1) documentation is considered a waste of time and (2) documentation of processes and procedures makes the individual less dependable” [2]. SMEs in this state perform some or all of the processes required by ISO 9001 and the QMS may function fairly well. However, they are not willing and ready to document those processes unless there is a cultural change lead by top management.
3. Formally Death: Some level of documentation, no functioning.
SMEs categorized in this state have documented processes and procedures at some degree, however, the documents are generally not followed and do not necessarily reflect the actual manner in which the organization undertakes its operations and management. This situation highlights the fact that the mere existence of documentation does not necessarily lead to a functional QMS. Moreover, such a situation may help perpetuate the view that ISO 9001 is a way for SMEs to market their products and services but that implementation of the standard requires stacks of documents that offer no value.
4. Formally Alive: Some level of documentation, some level of functioning.
Each SME considered in this state, achieves a unique combination of the existence and functionality of processes and procedures that may or may not be required by ISO 9001. This situation is closest to the desired state of full functionality (100%) of the ISO 9001 QMS and full documentation (100%) of this functionality.
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The Benefits To Integrate ISO 14001:2004 and ISO 9001:2008
Reduce the time and cost of implementing the new specification by acquiring a concise, yet thorough understanding the scope of ISO 14001:2004 and key terms.
Avoid spinning your wheels by learning precisely which modifications and additions to ISO 14001:2004 require your attention for compliance with ISO 9001:2008.
Get a quick handle, through hands-on activities, on the environmental aspects of ISO 14001:2004, including how to:- Develop an environmental policy statement appropriate for your company- Integrate processes for identifying environmental aspects and impacts- Identify environmental objectives, set related targets, and establish programs for achieving results- Integrate environmental responsibilities and authorities into a management system- Outline an environmental awareness and training program- Establish environmental metrics and indicators for monitoring performance- Integrate requirements on non-conformance and corrective and preventive actions into your existing system- Understand the purpose and scope of the environmental management review- Integrate document control requirements of ISO 14001:2004 into your current system- Identify those operations that need to be controlled under EMS and identify emergency operations and contingencies that must be considered as part of EMS
Get off to a running start by learning to use a versatile prioritization matrix to identify and prioritize significant environmental aspects and impacts.
Optimize understanding and retention with the Plexus Learning Model- Multiple learning channels through lecture, coaching, group activities, innovative learning exercises and case studies.- Hands-on insights. Lecturing is minimized so learning is maximized.- Learn by doing. Connect the lessons learned to your real world by using your current circumstances as examples for activities.
Reduce the time and cost of implementing the new specification by acquiring a concise, yet thorough understanding the scope of ISO 14001:2004 and key terms.
Avoid spinning your wheels by learning precisely which modifications and additions to ISO 14001:2004 require your attention for compliance with ISO 9001:2008.
Get a quick handle, through hands-on activities, on the environmental aspects of ISO 14001:2004, including how to:- Develop an environmental policy statement appropriate for your company- Integrate processes for identifying environmental aspects and impacts- Identify environmental objectives, set related targets, and establish programs for achieving results- Integrate environmental responsibilities and authorities into a management system- Outline an environmental awareness and training program- Establish environmental metrics and indicators for monitoring performance- Integrate requirements on non-conformance and corrective and preventive actions into your existing system- Understand the purpose and scope of the environmental management review- Integrate document control requirements of ISO 14001:2004 into your current system- Identify those operations that need to be controlled under EMS and identify emergency operations and contingencies that must be considered as part of EMS
Get off to a running start by learning to use a versatile prioritization matrix to identify and prioritize significant environmental aspects and impacts.
Optimize understanding and retention with the Plexus Learning Model- Multiple learning channels through lecture, coaching, group activities, innovative learning exercises and case studies.- Hands-on insights. Lecturing is minimized so learning is maximized.- Learn by doing. Connect the lessons learned to your real world by using your current circumstances as examples for activities.
SUMMARY OF CHANGES TO ISO 14001:2004
SUMMARY OF CHANGES TO ISO 14001:2004
ISO 14001:2004 aims to clarify the 1996 edition and align it more closely with the ISO 9001:2000 standard. Some clauses have not been modified for content but have been rewritten to align ISO 14001:2004 with the format, wording, and layout of ISO 9001:2000 and to enhance the compatibility between the two standards.
References in Annex A of the standard are aligned with the numbering in the standard for ease of use. Annex B of the standard identifies similarities and associations between ISO 9001:2000 and ISO 14001:2004.
An important change in wording throughout the revised standard appears in requirements that previously stated that an organisation shall “establish and maintain”; these have now been changed to “establish, implement and maintain”.
Throughout the standard the word “personnel” in the original standard is replaced with “persons working for or on behalf of the organisation” in the revised standard. This is included to ensure that external contractors and applicable suppliers are included under the requirements of certain clauses.
In developing, implementing and maintaining the organisation’s EMS, significant environmental aspects, applicable legal requirements and other requirements to which the organisation subscribes must be considered, and management must ensure the availability of resources.
There are additional paragraphs in the introduction, which generally cover:
• the aim of the ISO 14001:2004 standard is to enhance compatibility with ISO 9001:2000;
• alignment is improved between clause references and supporting Annexes. For example, 4.3.3 and A.3.3 both deal with objectives, targets and programme(s), and 4.5.5 and A.5.5 both deal with internal audit;
• an explanation of the Plan-Do-Check-Act (PDCA) model used in ISO 9001:2000;
• the use of the process approach is promoted in alignment with ISO 9001:2000;
• possible alignment and integration with other management systems is reviewed.
ISO 14001:2004 aims to clarify the 1996 edition and align it more closely with the ISO 9001:2000 standard. Some clauses have not been modified for content but have been rewritten to align ISO 14001:2004 with the format, wording, and layout of ISO 9001:2000 and to enhance the compatibility between the two standards.
References in Annex A of the standard are aligned with the numbering in the standard for ease of use. Annex B of the standard identifies similarities and associations between ISO 9001:2000 and ISO 14001:2004.
An important change in wording throughout the revised standard appears in requirements that previously stated that an organisation shall “establish and maintain”; these have now been changed to “establish, implement and maintain”.
Throughout the standard the word “personnel” in the original standard is replaced with “persons working for or on behalf of the organisation” in the revised standard. This is included to ensure that external contractors and applicable suppliers are included under the requirements of certain clauses.
In developing, implementing and maintaining the organisation’s EMS, significant environmental aspects, applicable legal requirements and other requirements to which the organisation subscribes must be considered, and management must ensure the availability of resources.
There are additional paragraphs in the introduction, which generally cover:
• the aim of the ISO 14001:2004 standard is to enhance compatibility with ISO 9001:2000;
• alignment is improved between clause references and supporting Annexes. For example, 4.3.3 and A.3.3 both deal with objectives, targets and programme(s), and 4.5.5 and A.5.5 both deal with internal audit;
• an explanation of the Plan-Do-Check-Act (PDCA) model used in ISO 9001:2000;
• the use of the process approach is promoted in alignment with ISO 9001:2000;
• possible alignment and integration with other management systems is reviewed.
Change In ISO 14001:2004 – Documentation
Change In ISO 14001:2004 – Documentation
This clause has been updated to align it with ISO 19001:2004, but has not changed in intent. The listed EMS documentation now includes:
• the environmental policy,
• objectives and targets,
• a description of the scope of the EMS,
• a description of the main elements of the EMS and their interaction and reference to related documents, documents and records
• required by the standard, • documents and records determined by the organisation as necessary to ensure the effective planning, operation and control of processes that relate to the significant environmental aspects.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
The revised standard requires documents required by the EMS and the standard to be controlled documents.
Note that “document” is included in the definitions, and includes its supporting medium which can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof.
This clause has been updated to align it with ISO 19001:2004, but has not changed in intent. The listed EMS documentation now includes:
• the environmental policy,
• objectives and targets,
• a description of the scope of the EMS,
• a description of the main elements of the EMS and their interaction and reference to related documents, documents and records
• required by the standard, • documents and records determined by the organisation as necessary to ensure the effective planning, operation and control of processes that relate to the significant environmental aspects.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
The revised standard requires documents required by the EMS and the standard to be controlled documents.
Note that “document” is included in the definitions, and includes its supporting medium which can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof.
ISO 14001:2004 Evaluation of compliance
ISO 14001:2004 Evaluation of compliance
This clause has been separated from 4.5.1 and includes two sub-clauses, as well as clarification and an addition to the ISO 14001:1996 standard. Included in Clause 4.5.1 of ISO 14001:1996 was a requirement for the organisation to periodically evaluate compliance with relevant (now applicable) environmental legislation and regulations. This requirement has been retained in Clause 4.5.2.1 of the revised standard. In Clause 4.5.2.2, ISO 14001:2004 includes evaluation of compliance with other requirements to which the organisation subscribes, which was not specifically required by ISO 14001:1996. This clarification also includes a requirement for records of periodic evaluations of compliance to be kept.
The UK-based Institute of Environmental Management and Assessment (IEMA) has published an opinion that this means that compliance against each and every piece of legislation / regulation relating to an organisation’s environmental aspects will need to be evaluated before it can be considered to be in conformity with ISO 14001: 2004; it will not be acceptable for organisations to claim that the periodic evaluation will be covered by their internal EMS audit program at some future date.
This has always been one of the most difficult issues in ISO 14001:2004, and organisations will need to review and revise their compliance procedures to ensure that they meet these new requirements.
This clause has been separated from 4.5.1 and includes two sub-clauses, as well as clarification and an addition to the ISO 14001:1996 standard. Included in Clause 4.5.1 of ISO 14001:1996 was a requirement for the organisation to periodically evaluate compliance with relevant (now applicable) environmental legislation and regulations. This requirement has been retained in Clause 4.5.2.1 of the revised standard. In Clause 4.5.2.2, ISO 14001:2004 includes evaluation of compliance with other requirements to which the organisation subscribes, which was not specifically required by ISO 14001:1996. This clarification also includes a requirement for records of periodic evaluations of compliance to be kept.
The UK-based Institute of Environmental Management and Assessment (IEMA) has published an opinion that this means that compliance against each and every piece of legislation / regulation relating to an organisation’s environmental aspects will need to be evaluated before it can be considered to be in conformity with ISO 14001: 2004; it will not be acceptable for organisations to claim that the periodic evaluation will be covered by their internal EMS audit program at some future date.
This has always been one of the most difficult issues in ISO 14001:2004, and organisations will need to review and revise their compliance procedures to ensure that they meet these new requirements.
IMPLEMENTATION GUIDANCE FOR ISO 9001:2008
IMPLEMENTATION GUIDANCE FOR ISO 9001:2008
This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.
While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.
Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.
A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
- the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
- feedback from the ISO/TC 176/Working Group on “Interpretations”
- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:
1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.
- Maintains consistency with ISO 9000 family of standards.
- Improves translatability.
This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.
While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.
Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.
A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
- the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
- feedback from the ISO/TC 176/Working Group on “Interpretations”
- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:
1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.
- Maintains consistency with ISO 9000 family of standards.
- Improves translatability.
Monday, September 14, 2009
Concept of quality – historical background
Concept Of Quality – Historical Background
The concept of quality as we think of it now first emerged out of the Industrial Revolution. Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet ‘quality criteria’. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. In the late 1800s pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor established Quality Departments to oversee the quality of production and rectifying of errors, and Ford emphasized standardization of design and component standards to ensure a standard product was produced. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to ‘catch’ defects. Application of statistical control came later as a result of World War production methods. Quality management systems are the outgrowth of work done by W. Edwards Deming, a statistician, after whom the Deming Prize for quality is named.
Quality, as a profession and the managerial process associated with the quality function, was introduced during the second-half of the 20th century, and has evolved since then. Over this period, few other disciplines have seen as many changes as the quality profession.
The quality profession grew from simple control, to engineering, to systems engineering. Quality control activities were predominant in the 1940s, 950s, and 1960s. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Like medicine, accounting, and engineering, quality has achieved status as a recognized profession.
The concept of quality as we think of it now first emerged out of the Industrial Revolution. Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet ‘quality criteria’. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. In the late 1800s pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor established Quality Departments to oversee the quality of production and rectifying of errors, and Ford emphasized standardization of design and component standards to ensure a standard product was produced. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to ‘catch’ defects. Application of statistical control came later as a result of World War production methods. Quality management systems are the outgrowth of work done by W. Edwards Deming, a statistician, after whom the Deming Prize for quality is named.
Quality, as a profession and the managerial process associated with the quality function, was introduced during the second-half of the 20th century, and has evolved since then. Over this period, few other disciplines have seen as many changes as the quality profession.
The quality profession grew from simple control, to engineering, to systems engineering. Quality control activities were predominant in the 1940s, 950s, and 1960s. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Like medicine, accounting, and engineering, quality has achieved status as a recognized profession.
Wednesday, September 9, 2009
Conducting An Initial Environmental Review For EMS
Conducting An Initial Environmental Review in ISO 14001 EMS
An initial environmental review covers all the aspects of an EMS. As a result of this review the organization knows its strengths and weaknesses, risks and opportunities regarding the current status of its EMS. The gap between the requirements of the EMS standard and the actual status of the organization shows which aspects the organization should focus its efforts on to improve the system. This leads directly to the development of an environmental management program that should fill the gaps.The Environmental review should focus on three key areas:- Examination of existing environmental management practices and procedures- Identification of significant environmental impacts and their priority- Identification of legal and regulatory requirements1. Examination of Existing Environmental Management Practices andProceduresThe methodology for assessing existing environmental management practices and procedures is proposed here using a questionnaire. The review team fills out this questionnaire by interviewing appropriate people, by analyzing existing documents and procedures dealing with environmental issues and by collecting information about environmental aspects of the organization’s operations, products and services.By conducting the initial environmental review, an organization-specific profile of strengths and weaknesses can be drawn up. Because the score in each EMS area shows the effort needed in terms of financial and human resources,the organization knows where to focus its efforts when building up an EMS and where the largest effort is needed.
2. Identification of Significant Environmental Aspects and their PriorityAn environmental policy requires top management to set priorities regarding environmental aspects. An initial review clearly shows where to set priorities regarding the EMS itself. But, it does not help to set priorities among different environmental problems. Many top managers feel pressure to do something for the environment and thus embark on some form of ?Eenvironmental activism?E often containing many isolated activities, but no clear direction. One way to solve this problem is to develop a so called ?Environmental exposure portfolio?EThe first step of this portfolio analysis is to assess the exposure and therefore the importance of different environmental aspects for an organization’s overall performance.The appropriate perspective and priorities of the environmental policy will differ depending on this preliminary analysis. The analysis should be conducted from the perspective of the stakeholders of the organization, their needs and their importance for the success of the organization. The degree of exposure to different environmental aspects should guide the involvement and perspective of an organization when implementing an EMS. Evaluating exposure to environmental aspects is important, because this exposure is likely to influence the organization’s success sooner or later, either through new legislation, public or consumer perception and behavior or otherwise.The analysis of the expected exposure of an organization to different environmental problems and the weight given to these aspects by various stakeholders enables management to focus on environmental issues that are a high priority to the organization. This is represented in the quadrant in the upper right corner of the environmental exposure portfolio. However, the two quadrants on the left must also be observed, although less vigorously. Issues with low public priority, to which the firm contributes heavily become a problem as soon as the perception of the stakeholders and the public environmental policy changes (the quadrant in the upper left corner of the portfolio). That this can happen very rapidly is obvious, for example from Shell`s ?Brent Spar?Edumping case (detailed information about this case is available from Shell or Greenpeace at their respective WWW-sites). Investments in new production technology, products and services can increase the environmental impact of the organization when not anticipated early enough. In this case, a problem ranked in the lower right corner of the portfolio would shift to the field with the highest priority. Problems ranked in the lower left corner are of no priority. No measures should be taken here.
3. Identification of Legal and Regulatory RequirementsThe identification of legal and regulatory requirements assesses two levels of an organization:- production-related environmental regulations- product- and service-related environmental regulationsThe former addresses the production department while the latter addresses the marketingand R&D departments. Basically, three questions must be answered:- Which are the relevant environmental regulations? (= target)- Is the current situation in the organization known? (= actual)- Does the organization comply with relevant regulations? (=gap)The methodology used here is a questionnaire. To obtain information about environmental regulations the following information sources can be used:- governmental authorities- industry associations- daily newspaper- university publications (law departments)
An initial environmental review covers all the aspects of an EMS. As a result of this review the organization knows its strengths and weaknesses, risks and opportunities regarding the current status of its EMS. The gap between the requirements of the EMS standard and the actual status of the organization shows which aspects the organization should focus its efforts on to improve the system. This leads directly to the development of an environmental management program that should fill the gaps.The Environmental review should focus on three key areas:- Examination of existing environmental management practices and procedures- Identification of significant environmental impacts and their priority- Identification of legal and regulatory requirements1. Examination of Existing Environmental Management Practices andProceduresThe methodology for assessing existing environmental management practices and procedures is proposed here using a questionnaire. The review team fills out this questionnaire by interviewing appropriate people, by analyzing existing documents and procedures dealing with environmental issues and by collecting information about environmental aspects of the organization’s operations, products and services.By conducting the initial environmental review, an organization-specific profile of strengths and weaknesses can be drawn up. Because the score in each EMS area shows the effort needed in terms of financial and human resources,the organization knows where to focus its efforts when building up an EMS and where the largest effort is needed.
2. Identification of Significant Environmental Aspects and their PriorityAn environmental policy requires top management to set priorities regarding environmental aspects. An initial review clearly shows where to set priorities regarding the EMS itself. But, it does not help to set priorities among different environmental problems. Many top managers feel pressure to do something for the environment and thus embark on some form of ?Eenvironmental activism?E often containing many isolated activities, but no clear direction. One way to solve this problem is to develop a so called ?Environmental exposure portfolio?EThe first step of this portfolio analysis is to assess the exposure and therefore the importance of different environmental aspects for an organization’s overall performance.The appropriate perspective and priorities of the environmental policy will differ depending on this preliminary analysis. The analysis should be conducted from the perspective of the stakeholders of the organization, their needs and their importance for the success of the organization. The degree of exposure to different environmental aspects should guide the involvement and perspective of an organization when implementing an EMS. Evaluating exposure to environmental aspects is important, because this exposure is likely to influence the organization’s success sooner or later, either through new legislation, public or consumer perception and behavior or otherwise.The analysis of the expected exposure of an organization to different environmental problems and the weight given to these aspects by various stakeholders enables management to focus on environmental issues that are a high priority to the organization. This is represented in the quadrant in the upper right corner of the environmental exposure portfolio. However, the two quadrants on the left must also be observed, although less vigorously. Issues with low public priority, to which the firm contributes heavily become a problem as soon as the perception of the stakeholders and the public environmental policy changes (the quadrant in the upper left corner of the portfolio). That this can happen very rapidly is obvious, for example from Shell`s ?Brent Spar?Edumping case (detailed information about this case is available from Shell or Greenpeace at their respective WWW-sites). Investments in new production technology, products and services can increase the environmental impact of the organization when not anticipated early enough. In this case, a problem ranked in the lower right corner of the portfolio would shift to the field with the highest priority. Problems ranked in the lower left corner are of no priority. No measures should be taken here.
3. Identification of Legal and Regulatory RequirementsThe identification of legal and regulatory requirements assesses two levels of an organization:- production-related environmental regulations- product- and service-related environmental regulationsThe former addresses the production department while the latter addresses the marketingand R&D departments. Basically, three questions must be answered:- Which are the relevant environmental regulations? (= target)- Is the current situation in the organization known? (= actual)- Does the organization comply with relevant regulations? (=gap)The methodology used here is a questionnaire. To obtain information about environmental regulations the following information sources can be used:- governmental authorities- industry associations- daily newspaper- university publications (law departments)
Introduction to ISO Certification
Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000″. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performance
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000″. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performance
Business benefits of ISO 14000
Business Benefits Of ISO 14001
Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.
Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.
Thursday, September 3, 2009
Structure Of ISO 9001
ISO 9001 was first published in 1987. Later, it went through three revisions in 1994, 2000 and 2008. The latest version version of the ISO 9001 standard was published on 14th November 2008. This is the structure of the standard:
Clause 1 Scope
Clause 2 Normative reference
Clause 3 Terms and definitions
Clause 4 Quality management system
Clause 5 Management responsibility
Clause 6 Resource management
Clause 7 Product realization
Clause 8 Measurement, analysis and improvement
http://www.e-wia.com
Clause 1 Scope
Clause 2 Normative reference
Clause 3 Terms and definitions
Clause 4 Quality management system
Clause 5 Management responsibility
Clause 6 Resource management
Clause 7 Product realization
Clause 8 Measurement, analysis and improvement
http://www.e-wia.com
Introduction to ISO Certification
Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000″. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performanceISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000″. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performanceISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.
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