Sunday, July 6, 2008
Wednesday, February 20, 2008
ISO 9001 Approach
The ISO standards are structured around the Process Approach concept. Two of the eight quality management principles are key to understanding this principle:
Process Approach - Understand and organize company resources and activities to optimize how the organization operates.
System Approach to Management - Determine sequence and interaction of processes and manage them as a system. Processes must meet customer requirements.
Therefore, when company resources and activities are optimally organized, and managed as a system, the desired result is achieved more efficiently.
In order to effectively manage and improve your processes, use the Plan-Do-Check-Act or PDCA cycle as a guide. First, you Plan by defining your key processes and establishing quality standards for those processes. Next, you Do by implementing the plan. Thirdly, you Check by using measurements to assess compliance with your plan, and finally, you Act by continuously improving your product performance.
Process Approach - Understand and organize company resources and activities to optimize how the organization operates.
System Approach to Management - Determine sequence and interaction of processes and manage them as a system. Processes must meet customer requirements.
Therefore, when company resources and activities are optimally organized, and managed as a system, the desired result is achieved more efficiently.
In order to effectively manage and improve your processes, use the Plan-Do-Check-Act or PDCA cycle as a guide. First, you Plan by defining your key processes and establishing quality standards for those processes. Next, you Do by implementing the plan. Thirdly, you Check by using measurements to assess compliance with your plan, and finally, you Act by continuously improving your product performance.
Monday, February 18, 2008
ISO 9001:2000 Snap Shot
Quality policy - Develop a statement of your company's commitment to quality. Use this framework for subsequent planning and action.
Quality aspects - Identify quality attributes of your company's products, activities and customer services. Determine the attributes that have or could have significant impacts on the quality. Keep this information up-to-date.
Legal and other requirements - Identify and provide access to laws and regulations that are relevant to your company (as well as other requirements to which it adheres).
Objectives and targets - Establish quality goals in line with your company's quality policy. Consider significant quality aspects, legal and other requirements and the views of interested parties, among other specified factors.
Quality management programs - Plan actions to achieve quality objectives and targets. Define "who, what, how and when" in these programs.
Structure and responsibility - Establish roles and responsibilities for quality management and provide adequate resources. Appoint a top management representative for the quality management system (QMS) with specific responsibilities.
Training, awareness and competence - Ensure that your employees receive proper training, are aware of QMS requirements and are capable of carrying out their quality management responsibilities.
Communication - Establish processes for internal and external communications on quality management issues. Consider communicating externally on your company's significant quality aspects.
QMS documentation - Maintain information on your QMS and related documents. Document control - Ensure effective management of operating procedures and other quality management system documents.
Operational control - Identify, plan and manage your operations and activities in line with your quality policy, objective and targets. Define requirements (as needed) for contractors and suppliers.
Emergency preparedness and response - Identify potential emergencies and develop procedures for preventing and responding to them.
Monitoring and measurement - Monitor key activities and track performance. Conduct periodic compliance evaluations.
Nonconformance and corrective/preventive action - Identify and correct problems and prevent reoccurrence.
Records - Keep adequate records of your QMS and its performance.
QMS audits - Conduct audits periodically to verify that your QMS is operating as intended.
Management review - Periodically review your QMS with an eye to continual improvement of the system.
Quality aspects - Identify quality attributes of your company's products, activities and customer services. Determine the attributes that have or could have significant impacts on the quality. Keep this information up-to-date.
Legal and other requirements - Identify and provide access to laws and regulations that are relevant to your company (as well as other requirements to which it adheres).
Objectives and targets - Establish quality goals in line with your company's quality policy. Consider significant quality aspects, legal and other requirements and the views of interested parties, among other specified factors.
Quality management programs - Plan actions to achieve quality objectives and targets. Define "who, what, how and when" in these programs.
Structure and responsibility - Establish roles and responsibilities for quality management and provide adequate resources. Appoint a top management representative for the quality management system (QMS) with specific responsibilities.
Training, awareness and competence - Ensure that your employees receive proper training, are aware of QMS requirements and are capable of carrying out their quality management responsibilities.
Communication - Establish processes for internal and external communications on quality management issues. Consider communicating externally on your company's significant quality aspects.
QMS documentation - Maintain information on your QMS and related documents. Document control - Ensure effective management of operating procedures and other quality management system documents.
Operational control - Identify, plan and manage your operations and activities in line with your quality policy, objective and targets. Define requirements (as needed) for contractors and suppliers.
Emergency preparedness and response - Identify potential emergencies and develop procedures for preventing and responding to them.
Monitoring and measurement - Monitor key activities and track performance. Conduct periodic compliance evaluations.
Nonconformance and corrective/preventive action - Identify and correct problems and prevent reoccurrence.
Records - Keep adequate records of your QMS and its performance.
QMS audits - Conduct audits periodically to verify that your QMS is operating as intended.
Management review - Periodically review your QMS with an eye to continual improvement of the system.
The Future of ISO 9001
Recently, ISO Technical Committee (TC) 176 announced that, based on the maturity of the amendment to ISO 9001, a second committee draft would not be required, and the publication date would be moved up from May 2009 to October 2008. This announcement, along with the amount of change in the amendment, has triggered much conversation in the user community. Topics heard around the water cooler include, “Why didn’t the drafters change more?” and, “If the changes are minimal, why not publish now?”
questions are wrapped up in ISO Guide 72. This is the document under which each management system standard is initiated, developed, and maintained. It has very specific rules that ISO technical committees must follow, including that each standard is to be reviewed every five years.
It was in 2004, during the mandatory five-year review, that TC 176 conducted the required market and justification studies. As a part of these studies, participating countries could vote to confirm the standard as is, amend, or revise. Although there were some votes to confirm the standard, the majority of the votes were cast to amend ISO 9001.
When the decision was made to amend ISO 9001, the drafters were faced with a unique challenge. ISO directives do not differentiate between an amendment and revision. To satisfy the users’ desire for an amendment, the drafters implemented a risk assessment matrix that analyzed changes to ensure that the effect of a change did not outweigh the benefit. They also needed to make sure that not only were changes understood, but also that changes could not be misunderstood. These limits influenced the number of changes made in the amendment.
The ISO directives also limited TC 176 in what it was able to do once it determined that the amendment had reached maturity. These directives dictate the length of time for comments that must be provided for draft international standards and final draft international standards. They also require documents to be translated into the official languages of French and German. Comments from participating countries must also be provided in English.
In most cases, because amendments have less change than revisions, it could be assumed that less time would be required to translate the document into the required languages. It could also be assumed that less time would be needed by users to provide comments. However, the ISO directives do not provide for either scenario.
In June 2007, TC 176 determined that the only stage that could be foregone in the planned schedule was eliminating the second committee draft, thereby going straight to draft international standard.
Fast-forward to 2008. Organizations that have had more transition time under their belts are now wondering why there isn’t more change. They are also wondering why the standard cannot be published now. It is difficult to determine whether a review of ISO 9001:2000 conducted now instead of in 2005 would have created less inertia for a revision. Additionally, if users knew the depth to this amendment, would their viewpoints be any different?
Is there anything we can do to help influence how standards are amended and/or revised in the future?
After publication of the amendment, users need to participate in surveys and provide feedback regarding what they like or don’t like. Without this feedback, the process will be assumed to be acceptable and remain unchanged.
We are in this scenario because of ISO Guide 72, but the fact remains that this guide exists to maintain the integrity of standards, and that its benefits outweigh any issues for the most part. The question remains: Will this guidance document drive TC 176 in the future to follow the same path as it has with ISO 9001:2008? It is difficult to say, but based on user feedback received thus far, not likely .
About the author
Lorri M. Hunt has more than thirteen years of experience in implementing quality management systems in diverse organizations. She is an active member of the U. S. Technical Advisory Group to ISO Technical Committee 176. She currently serves in the key position of chair of Task Group 9001/4, the United States group responsible for developing consensus positions related to ISO 9001 and 9004 .
ISO 9001 has been around for 20 years. Dr. Seuss’ classic, Oh, the Places You’ll Go, could not have been less likely or ultimately more prophetic in describing the course or meteoric success of this international quality management system (QMS) standard. It has crisscrossed the globe, attracting disciples and penetrating markets, industries, and professions that no one could have anticipated.
The “next big thing” of the 1980s has morphed from a fad into a well-established and universally recognized standard of quality. It is not going away.
ISO 9001 endures as an extraordinarily versatile document. How many other standards remain virtually unchanged, regardless of geography? From Prague to Bangkok to Bogotá to Kansas City, the requirements are identical. This broad appeal is due largely to its elegant minimalism and generic applicability. The concepts of customer, process, supply chain, and improvement are universal. So is the application of the ISO 9001 standard. This, I believe, is the nugget at the core of its success--its universality.
Of course, universality would be moot were it not for the fact that the standard is a very good architecture for a QMS. It works well across an astonishing variety of industries. From manufacturing to service, small shops to multinational corporations, moneymaking enterprises to nonprofits and governmental agencies, the standard has proven its worth as an effective model for managing an organizational system.
Future revisions
Like everything else, ISO 9001 needs to be updated and revised to remain relevant. If it is to endure as the benchmark of QMS models, we need to apply the same requirements for monitoring, focus on the customer, and continual improvement that are hallmarks of the standard itself.
The technical experts of ISO/TC 176, the individuals who write and update the ISO 9000 series of standards, have been vigilant in gathering data from user communities and reviewing the feedback from the market. The results of the data analysis have yielded two key decisions: First, ISO 9001:2008 would be an amendment with only minor changes, and second, ISO 9001:2015 (approximate date) would result in a more extensive revision, addressing global and technological changes in the marketplace. Thus, all the feedback that was appropriate for the amendment was addressed in the upcoming version. The issues that couldn’t be accommodated through a simple amendment were tabled for the next revision.
All of this bodes well for ISO 9001. It allows the standard’s users to mature their systems without worrying about a repeat of the upheaval that some experienced when the 2001 revision was published. It also allows technical experts the time they need to thoroughly address and properly react to the changes that will affect the continued utility of the standard.
There are two major categories of consideration that will go into the next revision. The first relates to sector- specific standards; the second, to improvements and changes in technology, supply chain management, and globalization. The manner in which both of these are addressed will have a long-range effect on the continued viability of ISO 9001.
Sector-specifics
Over the years there’s been a proliferation of sector-specific standards based on ISO 9001. In the last two years, standards have been added relating to crop production and the petroleum industry. They join the now-mature standards in such areas as medical device, automotive, telecommunications, and aerospace. The standards field has been further augmented by standards relating to environmental issues, health and safety, and laboratory accreditation.
Sector-specific standards carry benefits and drawbacks. For the most part, they’re founded on ISO 9001. This facilitates incorporating them into an existing ISO 9001-registered QMS. Their sector-specific nature revolves around the addition of requirements that are unique to a particular industry. For example, automotive suppliers, registered to ISO/TS 16949, deal with production part approval process (PPAP) and failure mode and effects analysis (FMEA). Organizations that sell within the medical-device industries (ISO 13485) have tiered requirements based on whether or not a device is implantable. Purveyors to the telecommunications industry (TL 9000) have varied requirements embedded in the standard to address hardware, software, and service providers. There are similar examples for the other half-dozen or so sector-specific standards. Although the requirements are appropriate and reasonable, it’s important to recognize the challenges and constraints that they present for users.
It can be daunting for an organization selling into several of these markets to develop a QMS that incorporates the requirements of multiple sector-specific standards effectively and efficiently. At one time there was a concern that these stepchildren would dilute the effectiveness of ISO 9001. There was a fear that customers would choose one of the sector-specific standards and ignore ISO 9001. There was also the likelihood that the market would simply abandon any standards if compliance to multiple standards became too unwieldy. Although this second scenario is becoming less likely, I think that the authors of ISO 9001 need to reflect on the challenges and ensure that the next revision does not exacerbate the potential problem.
The technical experts of ISO/TC 176 cannot turn a blind eye to the fact that these standards are squarely founded on ISO 9001. Therefore, revisions should not contain language that conflicts with the sector-specific standards. They also need to ensure that they don’t include requirements or language that place unnecessary burdens on some industries for which a particular requirement might be inappropriate or irrelevant. This can probably be best handled by retaining the generic and universal tone that has contributed so heavily to ISO 9001’s success.
The various industry bodies sponsoring the sector-specific standards are also rightly concerned that a major change to ISO 9001 will inevitably necessitate revisions to their unique standards if they wish to retain compatibility with ISO 9001. In addition, some of the standards, most notably the automotive industry’s ISO/TS 16949, rely on ISO 9001 as the recognized QMS models for which the second- and third-tier suppliers for which registration to standards such as ISO/TS 16949 would be inappropriate or unnecessarily burdensome. Changes, therefore, should not be made lightly or frivolously.
ISO 14001 and OHSAS 18001 differ somewhat from the other sector-specific standards in that they relate respectively to environmental issues and health and safety concerns. ISO/TC 207 is the technical committee responsible for the ISO 14000 series of standards. For several years, it and the technical experts from ISO/TC 176 have striven to align the language of these two standards. This is expected to be another of the myriad inputs into the next major revision of ISO 9001. OHSAS 18001 is a newer arrival and, although a formal commitment to alignment has not been made, the authors of ISO 9001 will not be able to ignore its growing influence.
Outsourcing and offshoring
There were several other factors that were the subject of discussion at the most recent meetings of TC 176/SC2 (the ISO subcommittee directly responsible for work on ISO 9000, ISO 9001, and ISO 9004).
The most prominent factors deal with various aspects of the supply chain, specifically, outsourcing of processes, globalization, environmental factors, and information management.
Within the context of ISO 9001, outsourcing refers to those processes needed by the organization that are performed by an external entity. The decision to outsource can be based either on the determination that the organization does not have the requisite resources or ability to effectively implement the process, or that it would be more financially advantageous to have someone else do it. Typical examples include third-party testing and verification, development of user manuals, packaging, heat-treating, and technical support help lines.
The technical experts have recognized that outsourcing is a growing aspect of many organizations. It serves to extend product offerings, increase aftermarket service opportunities, and augment capabilities. Outsourcing can reduce overhead, defer the need for capital expenditures, mitigate risks resulting from spikes in demand, and contribute to lean initiatives.
Currently, ISO 9001 has limited language addressing the requirements surrounding outsourced processes. As outsourcing becomes more widespread, it will be appropriate to insert additional language, proportionate to the prevalence of the practice.
A growing amount of the outsourcing is also going offshore, as have many other links in the supply chain. Raw materials, components, finished goods, and customer service now come to us from almost every corner of the globe. The authors of ISO 9001 anticipate that the standard will inevitably need to more extensively address requirements unique to these long-distance suppliers. There are specific constraints that accompany global supplier relations. Distance, transportation, time zones, cultural differences, communication, and infrastructure reliability can all affect intercontinental partnerships. Although ISO 9001 deals with supplier-related issues, the text will need to be revised to remain relevant to evolving market practices.
This leads us to the other factor that was barely a blip on the screen when ISO 9001 was first released: the internet. Among other things, the worldwide web has facilitated the outsourcing and globalization of the supply chain, and that’s only one aspect of the growing field of information-management technologies. Our reliance on electronic media for communication, document control, marketing, training, and e-commerce has grown exponentially during the last 15 years. Internally, organizations rely heavily on software to manage documentation, notification, scheduling, project planning, product design, traceability, and general communication.
ISO 9001 contains language addressing all of the above in pre-electronic-era terminology. With the exception of the occasional note relating to electronic media, the standard does not reflect the explosion of this technology or its effect on our lives. Because this issue permeates every aspect of the modern organization, it will be better addressed with the due diligence that accompanies the next major revision.
Many of these factors were barely perceptible when decisions concerning the next revision were made by ISO/TC 176. The amendment provides a well- controlled intercession between the 2000 release and the next major revision. During the intervening years, the technical experts will have the time to solicit more input from the user community, aggregate and analyze the data, and develop the next generation of the 9001 standard to ensure its continued relevance and success.
The future of ISO 9001 relies on two things: retention of the features that have contributed perennially to its popularity and periodic revisions to ensure its continued applicability in our ever-changing world.
About the author
Denise Robitaille is an RABQSA-certified lead assessor, ASQ-certified quality auditor and a member of the U.S. TAG to ISO/TC 176. She’s the author of numerous articles as well as The Corrective Action Handbook , The Preventive Action Handbook, The Management Review Handbook and Document Control, all published by Paton Professional. Robitaille also writes “The Standard Answer” column in Quality Digest’s Inside Standards e-mail newsletter. Visit http://qualitydigest.com/standards/index.lasso to read recent columns or subscribe for free.
by Denise Robitaille
ISO 9001 Revisions:
User Comments
by Lorri M. Hunt
questions are wrapped up in ISO Guide 72. This is the document under which each management system standard is initiated, developed, and maintained. It has very specific rules that ISO technical committees must follow, including that each standard is to be reviewed every five years.
It was in 2004, during the mandatory five-year review, that TC 176 conducted the required market and justification studies. As a part of these studies, participating countries could vote to confirm the standard as is, amend, or revise. Although there were some votes to confirm the standard, the majority of the votes were cast to amend ISO 9001.
When the decision was made to amend ISO 9001, the drafters were faced with a unique challenge. ISO directives do not differentiate between an amendment and revision. To satisfy the users’ desire for an amendment, the drafters implemented a risk assessment matrix that analyzed changes to ensure that the effect of a change did not outweigh the benefit. They also needed to make sure that not only were changes understood, but also that changes could not be misunderstood. These limits influenced the number of changes made in the amendment.
The ISO directives also limited TC 176 in what it was able to do once it determined that the amendment had reached maturity. These directives dictate the length of time for comments that must be provided for draft international standards and final draft international standards. They also require documents to be translated into the official languages of French and German. Comments from participating countries must also be provided in English.
In most cases, because amendments have less change than revisions, it could be assumed that less time would be required to translate the document into the required languages. It could also be assumed that less time would be needed by users to provide comments. However, the ISO directives do not provide for either scenario.
In June 2007, TC 176 determined that the only stage that could be foregone in the planned schedule was eliminating the second committee draft, thereby going straight to draft international standard.
Fast-forward to 2008. Organizations that have had more transition time under their belts are now wondering why there isn’t more change. They are also wondering why the standard cannot be published now. It is difficult to determine whether a review of ISO 9001:2000 conducted now instead of in 2005 would have created less inertia for a revision. Additionally, if users knew the depth to this amendment, would their viewpoints be any different?
Is there anything we can do to help influence how standards are amended and/or revised in the future?
After publication of the amendment, users need to participate in surveys and provide feedback regarding what they like or don’t like. Without this feedback, the process will be assumed to be acceptable and remain unchanged.
We are in this scenario because of ISO Guide 72, but the fact remains that this guide exists to maintain the integrity of standards, and that its benefits outweigh any issues for the most part. The question remains: Will this guidance document drive TC 176 in the future to follow the same path as it has with ISO 9001:2008? It is difficult to say, but based on user feedback received thus far, not likely .
About the author
Lorri M. Hunt has more than thirteen years of experience in implementing quality management systems in diverse organizations. She is an active member of the U. S. Technical Advisory Group to ISO Technical Committee 176. She currently serves in the key position of chair of Task Group 9001/4, the United States group responsible for developing consensus positions related to ISO 9001 and 9004 .
ISO 9001 has been around for 20 years. Dr. Seuss’ classic, Oh, the Places You’ll Go, could not have been less likely or ultimately more prophetic in describing the course or meteoric success of this international quality management system (QMS) standard. It has crisscrossed the globe, attracting disciples and penetrating markets, industries, and professions that no one could have anticipated.
The “next big thing” of the 1980s has morphed from a fad into a well-established and universally recognized standard of quality. It is not going away.
ISO 9001 endures as an extraordinarily versatile document. How many other standards remain virtually unchanged, regardless of geography? From Prague to Bangkok to Bogotá to Kansas City, the requirements are identical. This broad appeal is due largely to its elegant minimalism and generic applicability. The concepts of customer, process, supply chain, and improvement are universal. So is the application of the ISO 9001 standard. This, I believe, is the nugget at the core of its success--its universality.
Of course, universality would be moot were it not for the fact that the standard is a very good architecture for a QMS. It works well across an astonishing variety of industries. From manufacturing to service, small shops to multinational corporations, moneymaking enterprises to nonprofits and governmental agencies, the standard has proven its worth as an effective model for managing an organizational system.
Future revisions
Like everything else, ISO 9001 needs to be updated and revised to remain relevant. If it is to endure as the benchmark of QMS models, we need to apply the same requirements for monitoring, focus on the customer, and continual improvement that are hallmarks of the standard itself.
The technical experts of ISO/TC 176, the individuals who write and update the ISO 9000 series of standards, have been vigilant in gathering data from user communities and reviewing the feedback from the market. The results of the data analysis have yielded two key decisions: First, ISO 9001:2008 would be an amendment with only minor changes, and second, ISO 9001:2015 (approximate date) would result in a more extensive revision, addressing global and technological changes in the marketplace. Thus, all the feedback that was appropriate for the amendment was addressed in the upcoming version. The issues that couldn’t be accommodated through a simple amendment were tabled for the next revision.
All of this bodes well for ISO 9001. It allows the standard’s users to mature their systems without worrying about a repeat of the upheaval that some experienced when the 2001 revision was published. It also allows technical experts the time they need to thoroughly address and properly react to the changes that will affect the continued utility of the standard.
There are two major categories of consideration that will go into the next revision. The first relates to sector- specific standards; the second, to improvements and changes in technology, supply chain management, and globalization. The manner in which both of these are addressed will have a long-range effect on the continued viability of ISO 9001.
Sector-specifics
Over the years there’s been a proliferation of sector-specific standards based on ISO 9001. In the last two years, standards have been added relating to crop production and the petroleum industry. They join the now-mature standards in such areas as medical device, automotive, telecommunications, and aerospace. The standards field has been further augmented by standards relating to environmental issues, health and safety, and laboratory accreditation.
Sector-specific standards carry benefits and drawbacks. For the most part, they’re founded on ISO 9001. This facilitates incorporating them into an existing ISO 9001-registered QMS. Their sector-specific nature revolves around the addition of requirements that are unique to a particular industry. For example, automotive suppliers, registered to ISO/TS 16949, deal with production part approval process (PPAP) and failure mode and effects analysis (FMEA). Organizations that sell within the medical-device industries (ISO 13485) have tiered requirements based on whether or not a device is implantable. Purveyors to the telecommunications industry (TL 9000) have varied requirements embedded in the standard to address hardware, software, and service providers. There are similar examples for the other half-dozen or so sector-specific standards. Although the requirements are appropriate and reasonable, it’s important to recognize the challenges and constraints that they present for users.
It can be daunting for an organization selling into several of these markets to develop a QMS that incorporates the requirements of multiple sector-specific standards effectively and efficiently. At one time there was a concern that these stepchildren would dilute the effectiveness of ISO 9001. There was a fear that customers would choose one of the sector-specific standards and ignore ISO 9001. There was also the likelihood that the market would simply abandon any standards if compliance to multiple standards became too unwieldy. Although this second scenario is becoming less likely, I think that the authors of ISO 9001 need to reflect on the challenges and ensure that the next revision does not exacerbate the potential problem.
The technical experts of ISO/TC 176 cannot turn a blind eye to the fact that these standards are squarely founded on ISO 9001. Therefore, revisions should not contain language that conflicts with the sector-specific standards. They also need to ensure that they don’t include requirements or language that place unnecessary burdens on some industries for which a particular requirement might be inappropriate or irrelevant. This can probably be best handled by retaining the generic and universal tone that has contributed so heavily to ISO 9001’s success.
The various industry bodies sponsoring the sector-specific standards are also rightly concerned that a major change to ISO 9001 will inevitably necessitate revisions to their unique standards if they wish to retain compatibility with ISO 9001. In addition, some of the standards, most notably the automotive industry’s ISO/TS 16949, rely on ISO 9001 as the recognized QMS models for which the second- and third-tier suppliers for which registration to standards such as ISO/TS 16949 would be inappropriate or unnecessarily burdensome. Changes, therefore, should not be made lightly or frivolously.
ISO 14001 and OHSAS 18001 differ somewhat from the other sector-specific standards in that they relate respectively to environmental issues and health and safety concerns. ISO/TC 207 is the technical committee responsible for the ISO 14000 series of standards. For several years, it and the technical experts from ISO/TC 176 have striven to align the language of these two standards. This is expected to be another of the myriad inputs into the next major revision of ISO 9001. OHSAS 18001 is a newer arrival and, although a formal commitment to alignment has not been made, the authors of ISO 9001 will not be able to ignore its growing influence.
Outsourcing and offshoring
There were several other factors that were the subject of discussion at the most recent meetings of TC 176/SC2 (the ISO subcommittee directly responsible for work on ISO 9000, ISO 9001, and ISO 9004).
The most prominent factors deal with various aspects of the supply chain, specifically, outsourcing of processes, globalization, environmental factors, and information management.
Within the context of ISO 9001, outsourcing refers to those processes needed by the organization that are performed by an external entity. The decision to outsource can be based either on the determination that the organization does not have the requisite resources or ability to effectively implement the process, or that it would be more financially advantageous to have someone else do it. Typical examples include third-party testing and verification, development of user manuals, packaging, heat-treating, and technical support help lines.
The technical experts have recognized that outsourcing is a growing aspect of many organizations. It serves to extend product offerings, increase aftermarket service opportunities, and augment capabilities. Outsourcing can reduce overhead, defer the need for capital expenditures, mitigate risks resulting from spikes in demand, and contribute to lean initiatives.
Currently, ISO 9001 has limited language addressing the requirements surrounding outsourced processes. As outsourcing becomes more widespread, it will be appropriate to insert additional language, proportionate to the prevalence of the practice.
A growing amount of the outsourcing is also going offshore, as have many other links in the supply chain. Raw materials, components, finished goods, and customer service now come to us from almost every corner of the globe. The authors of ISO 9001 anticipate that the standard will inevitably need to more extensively address requirements unique to these long-distance suppliers. There are specific constraints that accompany global supplier relations. Distance, transportation, time zones, cultural differences, communication, and infrastructure reliability can all affect intercontinental partnerships. Although ISO 9001 deals with supplier-related issues, the text will need to be revised to remain relevant to evolving market practices.
This leads us to the other factor that was barely a blip on the screen when ISO 9001 was first released: the internet. Among other things, the worldwide web has facilitated the outsourcing and globalization of the supply chain, and that’s only one aspect of the growing field of information-management technologies. Our reliance on electronic media for communication, document control, marketing, training, and e-commerce has grown exponentially during the last 15 years. Internally, organizations rely heavily on software to manage documentation, notification, scheduling, project planning, product design, traceability, and general communication.
ISO 9001 contains language addressing all of the above in pre-electronic-era terminology. With the exception of the occasional note relating to electronic media, the standard does not reflect the explosion of this technology or its effect on our lives. Because this issue permeates every aspect of the modern organization, it will be better addressed with the due diligence that accompanies the next major revision.
Many of these factors were barely perceptible when decisions concerning the next revision were made by ISO/TC 176. The amendment provides a well- controlled intercession between the 2000 release and the next major revision. During the intervening years, the technical experts will have the time to solicit more input from the user community, aggregate and analyze the data, and develop the next generation of the 9001 standard to ensure its continued relevance and success.
The future of ISO 9001 relies on two things: retention of the features that have contributed perennially to its popularity and periodic revisions to ensure its continued applicability in our ever-changing world.
About the author
Denise Robitaille is an RABQSA-certified lead assessor, ASQ-certified quality auditor and a member of the U.S. TAG to ISO/TC 176. She’s the author of numerous articles as well as The Corrective Action Handbook , The Preventive Action Handbook, The Management Review Handbook and Document Control, all published by Paton Professional. Robitaille also writes “The Standard Answer” column in Quality Digest’s Inside Standards e-mail newsletter. Visit http://qualitydigest.com/standards/index.lasso to read recent columns or subscribe for free.
by Denise Robitaille
ISO 9001 Revisions:
User Comments
by Lorri M. Hunt
Thursday, January 3, 2008
What is Quality
Quality is the customer’s perception of how a good or service is fit for their purpose and how it satisfies stated and implicit specifications.
Quality in an organization is best achieved by Management creating a Quality Management System (QMS). A QMS is a formalized system that documents the company structure, management and employee responsibilities, and the procedures required to deliver a quality product or service. Four quality tools should be utilized when creating a QMS: Quality Manual, Standard Operating Procedures (SOPs), work instructions and supporting documentation as flowcharts and quality records. All four tools must be consistent, coherent and work together to increase the perceived value of the good or service.
How do I manage Quality?
Quality Management is effectively managing your company QMS to achieve maximum customer satisfaction at the lowest overall cost. Quality Management (QM) is a continuous process that requires inputs of time, effort and commitment from all company resources.
Eight QM principles form the foundation for effective quality management:
Customer Focus - Understand your customer’s needs. Measure customer satisfaction. Strive to exceed their expectations.
Leadership - Management establishes the strategy and leads the company toward achieving its objectives. Management creates an environment that encourages staff to continuously improve and work towards satisfying the customer.
People Involvement - Train your staff effectively. Teamwork and full employee involvement makes quality a reality.
Continuous Improvement - Continue to make things better.
Process Approach - Understand and organize company resources and activities to optimize how the organization operates.
Factual Approach to Decision Making - Make decisions based on the facts. Data must be gathered, analyzed and assessed against the objectives.
System Approach to Management - Determine sequence and interaction of processes and manage them as a system. Processes must meet customer requirements.
Mutually Beneficial Supplier Relationships - Work with your suppliers to produce a win-win outcome.
Quality in an organization is best achieved by Management creating a Quality Management System (QMS). A QMS is a formalized system that documents the company structure, management and employee responsibilities, and the procedures required to deliver a quality product or service. Four quality tools should be utilized when creating a QMS: Quality Manual, Standard Operating Procedures (SOPs), work instructions and supporting documentation as flowcharts and quality records. All four tools must be consistent, coherent and work together to increase the perceived value of the good or service.
How do I manage Quality?
Quality Management is effectively managing your company QMS to achieve maximum customer satisfaction at the lowest overall cost. Quality Management (QM) is a continuous process that requires inputs of time, effort and commitment from all company resources.
Eight QM principles form the foundation for effective quality management:
Customer Focus - Understand your customer’s needs. Measure customer satisfaction. Strive to exceed their expectations.
Leadership - Management establishes the strategy and leads the company toward achieving its objectives. Management creates an environment that encourages staff to continuously improve and work towards satisfying the customer.
People Involvement - Train your staff effectively. Teamwork and full employee involvement makes quality a reality.
Continuous Improvement - Continue to make things better.
Process Approach - Understand and organize company resources and activities to optimize how the organization operates.
Factual Approach to Decision Making - Make decisions based on the facts. Data must be gathered, analyzed and assessed against the objectives.
System Approach to Management - Determine sequence and interaction of processes and manage them as a system. Processes must meet customer requirements.
Mutually Beneficial Supplier Relationships - Work with your suppliers to produce a win-win outcome.
What is ISO
ISO or the International Organization for Standardization is a non-governmental organization that was established in 1947. ISO includes a network of 157 national standards bodies (as of 9/12/06) from the world’s leading industrial nations. One of the main goals of ISO is to develop worldwide standardization by promoting adoption of international quality standards. By doing so, barriers of trade are eliminated.
ISO has created 15,000 standards as of 8/16/05 in a variety of industries. Examples of standards ISO has created include the standardized codes for country names, currencies and languages, standardized format of worldwide telephone and banking cards, as well as sizes and colors of road signs, and automobile bumper heights.
ISO includes 3,000 technical working bodies (as of 9/12/06), in which some 50,000 experts from industry, labor, government, and standardization bodies in all parts of the world develop and revise standards. ISO has created standards for the automotive, manufacturing, mechanics, packaging, and health care fields amongst many others.
Standards can be broadly sub-divided into three categories, namely product, process, and management standards. The first refers to characteristics related to quality and safety for example. Process standards refer to the conditions under which products and services are to be produced, packaged or refined. Management system standards assist organization to manage their operations. They are often used to help create a framework that then allows the organization to consistently achieve the requirements that are set out in product and process standards.
ISO has created 15,000 standards as of 8/16/05 in a variety of industries. Examples of standards ISO has created include the standardized codes for country names, currencies and languages, standardized format of worldwide telephone and banking cards, as well as sizes and colors of road signs, and automobile bumper heights.
ISO includes 3,000 technical working bodies (as of 9/12/06), in which some 50,000 experts from industry, labor, government, and standardization bodies in all parts of the world develop and revise standards. ISO has created standards for the automotive, manufacturing, mechanics, packaging, and health care fields amongst many others.
Standards can be broadly sub-divided into three categories, namely product, process, and management standards. The first refers to characteristics related to quality and safety for example. Process standards refer to the conditions under which products and services are to be produced, packaged or refined. Management system standards assist organization to manage their operations. They are often used to help create a framework that then allows the organization to consistently achieve the requirements that are set out in product and process standards.
What is ISO 9000
What is the difference between ISO 9000, ISO 9001, and ISO 9001:2000? And what are ISO 9002 and ISO 9003?
The quick answer is “none”. These terms are all used to describe the ISO 9001 standard. Prior to December 2000, there used to be an ISO 9001, an ISO 9002 and an ISO 9003 standard; without focusing on the technical differences between them, people would just simply refer to each as ISO 9000. In December 2000, the International Organization for Standardization (ISO) merged ISO 9001, ISO 9002, and ISO 9003 into a revised ISO 9001 standard. In order to distinguish between the previous ISO 9001 version, the current standard is often referred to as ISO 9001:2000 or ISO 9000:2000.
► Tip: More detailed information can be found on www.iso.ch.
Summary of the ISO 9001 Standard
The ISO 9000 standard contains requirements affecting virtually all aspects of any company. Because ISO 9000 is designed for any company of any size and in any industry, the requirements are rather broad and hard to read. The ISO 9001:2000 requirements fall into the following sections:
Section 1: Quality Management System
This section of the ISO 9001:2000 standard outlines the necessary steps to implement the ISO 9001 quality management system:
Identify the process (or activities) needed for the quality management system,
Determine the sequence and interaction of these processes,
Determine how these processes are effectively operated and controlled,
Ensure that all information is available to support the operation and monitoring of these processes,
Measure, monitor and analyze these processes, and implement action necessary to correct the processes and achieve continual improvement.
The ISO 9000 quality management system requires documentation that includes a quality manual, certain procedures, as well as work instructions. All documentation (including quality records) must be controlled according to a document control procedure. Also in this section, ISO 9001 emphasizes the need for continuous improvement.
► Tip: Most companies find the documentation requirements daunting. The use of templates can be of tremendous benefits. See our Product Collection section for your consideration.
Section 2: Management Responsibility
ISO 9001:2000 places great emphasis on top management’s commitment to quality. This section requires a quality policy and quality objectives, and it reinforces the involvement of top management with customer requirements.
This ISO 9001 section also requires top management to establish responsibilities and authorities within the company, including the establishment of an ISO 9000 management representative.
► Tip: Use a good standard format for all job descriptions – this will save much time when creating new job descriptions, when advertising positions, when performing employee evaluations, etc.
Section 3: Resource Management
This section of ISO 9001:2000 clarifies the requirement for a company to determine and provide, in a timely manner, resources (for example, equipment, facilities, etc) needed to implement and improve the processes of the ISO 9001 quality management system and to address customer satisfaction. This section also includes requirements for employee training, as well as for the physical facilities and the work environment.
► Tip: Integrate your company’s HR function well into your ISO 9001 quality system, and make them take on a leading role during the ISO 9001 implementation.
Section 4: Product Realization
The ISO 9001:2000 standard defines Product Realization as “that sequence of processes and sub processes required to achieve the product.” This is how your product is designed, produced, tested, handled, shipped, etc. This section also applies to service providers. Emphasis is placed on how the company understands, communicates and actually meets customer requirements. This section also contains various requirements for the design of products and for the planning of processes, projects and services.
► Tip: Most companies write work instructions and flowcharts to define and standardize their work processes. You will save yourself much time if you follow the ISO 9001 requirements for document control from the outset when writing these documents.
Section 5: Measurement, Analysis and Improvement
The last section of the ISO 9001:2000 standard closes the loop by providing requirements for measurement and monitoring activities, so that the company can immediately identify when not on track. Measurement and monitoring activities also include internal audits and the monitoring of customer perception as to whether the company has fulfilled customer requirements. All of these activities must be defined, planned and implemented. Measuring and monitoring allows the company to manage by fact, not by guess.
► Tip: This is a very important section of the ISO 9001 standard. Depending on how it is implemented, it can add tremendous value or create bureaucracy and waste. We highly recommend placing emphasis on this crucial ISO 9001 section.
The quick answer is “none”. These terms are all used to describe the ISO 9001 standard. Prior to December 2000, there used to be an ISO 9001, an ISO 9002 and an ISO 9003 standard; without focusing on the technical differences between them, people would just simply refer to each as ISO 9000. In December 2000, the International Organization for Standardization (ISO) merged ISO 9001, ISO 9002, and ISO 9003 into a revised ISO 9001 standard. In order to distinguish between the previous ISO 9001 version, the current standard is often referred to as ISO 9001:2000 or ISO 9000:2000.
► Tip: More detailed information can be found on www.iso.ch.
Summary of the ISO 9001 Standard
The ISO 9000 standard contains requirements affecting virtually all aspects of any company. Because ISO 9000 is designed for any company of any size and in any industry, the requirements are rather broad and hard to read. The ISO 9001:2000 requirements fall into the following sections:
Section 1: Quality Management System
This section of the ISO 9001:2000 standard outlines the necessary steps to implement the ISO 9001 quality management system:
Identify the process (or activities) needed for the quality management system,
Determine the sequence and interaction of these processes,
Determine how these processes are effectively operated and controlled,
Ensure that all information is available to support the operation and monitoring of these processes,
Measure, monitor and analyze these processes, and implement action necessary to correct the processes and achieve continual improvement.
The ISO 9000 quality management system requires documentation that includes a quality manual, certain procedures, as well as work instructions. All documentation (including quality records) must be controlled according to a document control procedure. Also in this section, ISO 9001 emphasizes the need for continuous improvement.
► Tip: Most companies find the documentation requirements daunting. The use of templates can be of tremendous benefits. See our Product Collection section for your consideration.
Section 2: Management Responsibility
ISO 9001:2000 places great emphasis on top management’s commitment to quality. This section requires a quality policy and quality objectives, and it reinforces the involvement of top management with customer requirements.
This ISO 9001 section also requires top management to establish responsibilities and authorities within the company, including the establishment of an ISO 9000 management representative.
► Tip: Use a good standard format for all job descriptions – this will save much time when creating new job descriptions, when advertising positions, when performing employee evaluations, etc.
Section 3: Resource Management
This section of ISO 9001:2000 clarifies the requirement for a company to determine and provide, in a timely manner, resources (for example, equipment, facilities, etc) needed to implement and improve the processes of the ISO 9001 quality management system and to address customer satisfaction. This section also includes requirements for employee training, as well as for the physical facilities and the work environment.
► Tip: Integrate your company’s HR function well into your ISO 9001 quality system, and make them take on a leading role during the ISO 9001 implementation.
Section 4: Product Realization
The ISO 9001:2000 standard defines Product Realization as “that sequence of processes and sub processes required to achieve the product.” This is how your product is designed, produced, tested, handled, shipped, etc. This section also applies to service providers. Emphasis is placed on how the company understands, communicates and actually meets customer requirements. This section also contains various requirements for the design of products and for the planning of processes, projects and services.
► Tip: Most companies write work instructions and flowcharts to define and standardize their work processes. You will save yourself much time if you follow the ISO 9001 requirements for document control from the outset when writing these documents.
Section 5: Measurement, Analysis and Improvement
The last section of the ISO 9001:2000 standard closes the loop by providing requirements for measurement and monitoring activities, so that the company can immediately identify when not on track. Measurement and monitoring activities also include internal audits and the monitoring of customer perception as to whether the company has fulfilled customer requirements. All of these activities must be defined, planned and implemented. Measuring and monitoring allows the company to manage by fact, not by guess.
► Tip: This is a very important section of the ISO 9001 standard. Depending on how it is implemented, it can add tremendous value or create bureaucracy and waste. We highly recommend placing emphasis on this crucial ISO 9001 section.
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