Lorri Hunt, Denise Robitaille, and Craig Williams  |  10/29/2008

Lorri Hunt, Denise Robitaille, and Craig Williams’s default image

The Insider's Guide to ISO 9001:2008

The key changes in the amendment that you need to know.

Editors note: The following is an excerpt of The Insiders’ Guide to ISO 9001:2008 , which was published November 1 by Paton Professional.

As users get their first glimpse of ISO 9001:2008, the question on everyone’s mind is, “What, if anything, will our organization need to do differently?” ISO 9001:2008 focuses on changes that organizations might make to better comply with the spirit of the standard without adding, deleting, or altering its requirements. It should not result in an extensive change to existing quality management systems (QMS). The changes are minor in nature and address such issues as the need for clarification, greater consistency, resolution of perceived ambiguities, and improved compatibility with ISO 14001, which relates to environmental management systems ( EMS).

What does this mean for users? Requirements in the standard are frequently referred to as “shalls.” For the purpose of this amendment, ISO 9001:2008 provides improvements for users without adding to or removing any of the “shalls.”

ISO/TC 176 (the technical committee responsible for the ISO 9000 series of standards) was careful not to make change just for the sake of making change. This was especially true when it came to editorial changes, which could have created the false impression that there was a change in requirements, carrying greater significance than was intended. In some instances, when the committee members couldn’t come to a consensus in determining if a change added or deleted a requirement, they opted to retain the existing text. It was decided to err on the side of caution rather than to contribute to any misunderstanding in the marketplace.

With that said, some of the changes that have been incorporated into this amendment have been or have the potential for being perceived differently than what the technical experts intended when they were drafting the document. To minimize this, the committee made some very deliberate word choices. Some of the changes appear to be mere nuances of similar concepts. However, they often carried the greatest potential for incorrect user interpretation. Other changes increased understanding across a broader range of product types, including service organizations. Finally, some changes to specific clauses were made based on the 2004 International User Feedback Survey. This survey was conducted after the publication of ISO 9001:2000 and invited respondents to identify areas they most wanted to see improved.

We will highlight those changes that seem to have the most importance and which will probably be of greatest concern to the average user. What follows is a discussion of the most significant subject matters addressed in ISO 9001:2008.


The term “outsourcing” has been discussed at length since the publication of ISO 9001:2000. In fact, it spurred guidance documents as well as articles to explain its use in subclause 4.1, as well as its relation to the purchasing process in subclause 7.4.1. In an attempt to clarify the intent, notes were added to subclause 4.1 that require the organization to identify processes to be completed by an external party and the factors influencing the nature and extent of control over these processes. The added text is in the form of notes, thereby serving to provide clarification--not additional requirements.

In reviewing the new note that clarifies the relationship of outsourcing to the organization’s purchasing process, it’s important to remember that this is just one of the methods that can be used to control the process. If the organization outsources a process to another party, such as a corporate headquarters, the purchasing process would not necessarily be sufficient to control the QMS implications of that process, so other methods would need to be established. Therefore, organizations need to analyze each process separately to determine the necessary controls.


Subclause 4.2, “Documentation requirements,” was identified in the 2004 International User Feedback Survey as an area that needed improvement. This was also an area of the standard where the technical experts were extremely careful to avoid adding or deleting requirements. This was due to the potential of requiring organizations to make extreme modifications to their QMS and to their documentation in particular.

The technical experts focused on clarifying what documentation was needed for the QMS by modifying subclause 4.2.1, “General.” Clarification was made by structuring this clause such that it did not identify records as a separate type of document. Additionally it was changed to indicate that a documented procedure required by ISO 9001 that is established, documented, implemented, and maintained can be a stand-alone document that addresses more than one procedure or be covered by more than one document.

The changes made to subclause 4.2.3, “Control of documents,” and 4.2.4, “Control of records,” were focused on improving the compatibility between ISO 9001 and ISO 14001.

Organizations should evaluate whether they should make changes to the structure of any of their procedures based on the clarification that procedures can be combined or stand-alone. These changes should focus on the needs of the organization and help improve its documentation system.

Management representative

The changes in subclause 5.5.2 aren’t significant if you count the number of words that changed. The only addition was to require that the management representative be a member of the “organization’s” management. Not many words were added, but there may be many companies that see this as a significant change. Primarily, there is a debate as to whether a company (particularly smaller companies) can use a contracted person to be the management representative based on this wording change. Although some individuals may interpret this to mean that the management representative must be a full-time employee of the organization, the requirement is that the management representative needs to be part of the organization’s management. This means a contracted person could serve in this role as long as he or she is also considered as part of management and has been assigned the necessary authority and responsibility.

When analyzing this change, organizations need to consider whether they have a person assigned as management representative who meets the criteria as explained above. Based on the results of this analysis, you may need to more clearly document the relationship of the management representative to the organization.

Competence of employees

A note has been added to subclause 6.2.1 stating that “conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.” This note was made to clarify that the conformity of product requirements can be affected by someone who builds the product (directly) or a buyer who is responsible for purchasing materials that are to be used in building the product (indirectly).

Why is there the potential for this change to be perceived as new or different? In the past, some organizations took a very specific viewpoint that only some of their employees affected the conformity of product to requirements. These were typically the employees who built the product or delivered the service. In doing this, they at times eliminated some employees who indirectly affect that conformity. This means that some organizations did not apply this clause as thoroughly as they should have. This note doesn’t change the original intention of the requirements of subclause 6.2.1, which is that personnel performing work affecting conformity to product requirements shall be competent. The emphasis is simply stressing that the effect can be direct or indirect.

Organizations need to consider if they have applied this clause to employees who affect conformity to product requirements indirectly as well as directly. If gaps are identified, competence for these employees should be established just as they are for employees who directly affect conformity.

Design review, verification, and validation

One of the clauses that users have struggled with in the past is 7.3, “Design and development.” ISO/TC 176 received many comments regarding the clarification of the design activities of review, verification, and validation. Specifically, users were confused on how these activities relate to each other and whether they could be conducted by themselves or simultaneously. Although the technical experts determined that ISO 9000 adequately defines “design” and “development,” it was apparent that users still did not understand their application. For that reason, a note was added to subclause 7.3.1 that indicates that these activities have distinct purposes but can be conducted by themselves or in combination with one another.

Organizations that include design and development in their QMS should evaluate if they have been conducting the activities of review, verification, and validation based on an understanding of what they thought the standard required rather than based on an infrastructure that works for the organization. Based on an improved understanding of the requirements, the organization may find that it can make improvements to streamline these activities.


Throughout the standard the word “devices” was changed to “equipment.” How did the technical experts come to this conclusion? During the creation of the design specification for the amendment, one of the areas requested for clarification was the term “device.” As background, the word “device” was used in ISO 9001:2000 to address devices that were not considered equipment, such as checklists.

In reviewing potential solutions and terminology as it existed in ISO 9000:2005, it was determined that the term “measuring equipment” included “measuring instruments,” which also could include devices. It’s also believed that the current first sentence, which indicates that the organization “shall determine the monitoring and measurement to be undertaken” addresses the use of devices.

The potential for misinterpretation exists in that some organizations may see this as a reduced requirement or that devices are no longer covered by this clause. Again, this does not change requirements, but clarifies for users what monitoring and measuring equipment includes.

Does the use of the word “equipment” instead of “device” require your organization to make any clarifying changes to your QMS? If you determine that you have not been including all of the required types of measuring equipment, your organization needs to identify these items and apply each of the requirements in subclause 7.6.

Monitoring and measurement of processes

Since ISO 9001:2000 was published, users have been confused about how the clause on monitoring and measuring processes is related to monitoring and measuring product. This confusion can be attributed to the phrase at the end of subclause 8.2.3, which indicates that actions taken shall be to “ensure conformity of the product.” This clause has been removed in ISO 9001:2008 to eliminate this confusion. In addition, a note has been added that indicates that the monitoring and measuring of processes should be appropriate in their relation to the effect on the conformity to product requirements and on the effectiveness of the QMS.

When reviewing this change, the organization needs to consider adjusting the processes it monitors and measures and the methods it uses.

Control of nonconforming product

Subclause 8.3 was revised to make it more relevant and user-friendly for service organizations. From the time that ISO 9001 was originally published, there has always been difficulty in applying subclause 8.3 to service organizations. This is because it’s almost impossible to identify a potential nonconformity prior to delivery to the customer, which results in the organization almost always being in a corrective action mode.

The technical experts evaluated several options to make this clause more universally applicable. The last paragraph from ISO 9001:2000 was added as one of the ways that an organization can deal with nonconforming product: “When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.” By implementing this approach, an organization can take action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery.

Another small change was to add the words “where applicable” as the lead-in to the text that addresses nonconforming product. This is to emphasize that where an organization can apply the requirements, it should. This clarification was made to stress that some organizations--based on the nature of their product type--may not be able to apply all of the methods for dealing with nonconforming product.

ISO/TC 176 thoroughly examined the potential for an organization not to apply certain aspects of the clause due to the revisions. It determined that the words “where applicable” puts the onus on organizations to apply the requirements where they can, and that the potential for misinterpreting this clause is far less than the benefits it derives for organizations that have struggled to comply.

Organizations, especially those in the service industry, should consider whether they can make enhancements to how they are controlling nonconforming product based on the inclusion of taking action appropriate to the effects of the nonconformity as a method of controlling nonconforming product. Any enhancements made due to this clarification should be included in the organization’s documented procedures.

Corrective and preventive action

The final change was made to subclauses 8.5.2 and 8.5.3. ISO 9001:2000 required the review of corrective and preventive action, respectively. The technical experts evaluated the consistency between these clauses and their counterparts in ISO 14001:2004 and ISO 19011. To improve the consistency, the technical experts decided to add the words “effectiveness of the” to the review of corrective and preventive actions in ISO 9001:2008.

In making this change the technical experts considered the term “review” in ISO 9000:2005. It was determined that the term “review” includes consideration of the effectiveness of an activity taken, so this change was not considered an additional requirement.

Users could perceive this as a change in requirements. However, effectiveness was always considered to be part of the activities of review for ISO 9001.

Organizations need to analyze their QMS to ensure that when they are reviewing corrective and preventive actions, they are considering the effectiveness of the actions taken. If your organization has not included a review of effectiveness, this should be incorporated into your QMS and the respective procedures updated.

Statutory and regulatory

One of the changes made throughout the standard was the change from “statutory” to “statutory and regulatory.” This includes changes made to subclause 0.1, “General,” in the Introduction section, as well as 1.1, “General,” and 1.2, “Application,” in the Scope section of ISO 9001:2008. There was considerable discussion during drafting the amendment about the distinction between the terms “statutory” and “regulatory.” These terms may give some countries the impression of change due to interpretation. In the United States it’s perfectly acceptable and appropriate to talk in terms of statutory and regulatory requirements as potentially different requirements. However, in most of the world these two terms are synonymous and are further complicated when ISO 14001 talks in terms of “legal” requirements. Although these items may seem trivial, the conversation they generate is very passionate and focused on a uniform and global understanding of the documents, particularly for tens of thousands of users who are not native English speakers.

To further clarify the meaning of “statutory and regulatory,” a note has been added that explains what is meant by these types of requirements as well as legal requirements.

Because the phrase “statutory and regulatory” already existed in ISO 9001:2000 subclause 7.2.1, ISO 9001:2008-compliant organizations shouldn’t have to change their QMS. However, organizations that have taken a minimal compliance approach in this area may need to consider whether the inclusion of “statutory” in the additional clauses changes any of the requirements they need to consider when determining the scope and application of their QMS.


About The Author

Lorri Hunt, Denise Robitaille, and Craig Williams’s default image

Lorri Hunt, Denise Robitaille, and Craig Williams

Lorri Hunt 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 9001/9004, the United States’ group responsible for developing consensus positions related to ISO 9001 and ISO 9004. She has also held several international positions on ISO/TC 176. Most recently she was appointed as the deputy task group leader for the current amendment to ISO 9001.

Denise Robitaille is the principal of Robitaille Associates, where she has helped companies in various industries achieve ISO 9001 registration. Her work also encompasses training and auditing. She is a RABQSA-certified lead assessor, an American Society for Quality-certified quality auditor, and a fellow of the ASQ. Robitaille is also an active member of the U.S. Technical Advisory Group to ISO/TC 176.

Craig Williams is corporate director of quality and performance improvement with Eaton Corp., a diversified power management company. He is a senior member of the ASQ and vice chair of Task Group 9001/9004 of the U.S. Technical Advisory Group to ISO/TC 176. He serves as an expert on the international drafting committee responsible for ISO 9001:2008 and represents U.S. interests on the Chairman’s Strategic Advisory Group of ISO/TC 176. He is also a former chair of the Automotive Industry Action Group’s Quality Steering Committee.