Friday, May 27, 2016
VOLUME -25 NUMBER 3
Publication Date: 03/1/2010
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ARCHIVE >  March 2010 Issue >  Tech Watch > 

Updating Your ISO 9001

ISO 9001:2008 is no longer hot off the presses, yet some organizations have not migrated from the 2000 version of the standard. The reasons vary. Most of the rationale is not based on the difficulty of the migration but based on timing. Some organizations have chosen to wait until their recertification audit, while others have gone through enormous change during the economic downturn and are waiting for their quality management system to stabilize.

Regardless of the reason, we will soon be approaching the migration deadline. ISO 9001:2008 was released in November 2008, and while the amendment was not meant to require a transition audit, organizations have until November 2010 to confirm their implementation of the standard with their certification body.

To gain a comfort level and understanding of what changes, if any, need to be made, it is critical to understand the purpose and scope of the amendment. Here are some of the key points that ISO 9001 users need to remember as they plan their migration.

ISO 9001:2008 is an amendment and not a revision. Since ISO directives do not differentiate between an amendment and revision, the technical experts defined the scope of an amendment in a design specification they used during the drafting process. This design specification helped the drafters stay on track for what the user community had requested during user surveys, no change in requirements. Parameters were defined in a risk matrix that each change was reviewed against to ensure that the modification that was being made was of high benefit and low impact. High benefit changes included those things identified in the design specification as goals of the amendment. Low impact changes included those types of changes that would require minimal change to an organization's existing QMS.

No New Requirements
ISO 9001:2008 does not add or delete requirements. This amendment does not include any new or deleted requirements. In addition, in order for a specific change to be made not only could it not change requirements, but it also could not give the perception that a requirement had been changed. For that reason, the amendment does not include wholesale text changes. In addition, the technical experts would lean toward no change if consensus could not be reached on whether the change added or deleted a requirement. Keeping in mind the spirit of the amendment, which was to make change without changing requirements, the technical experts had to be creative in how they incorporated the improvements. The following techniques were used.

  • Clauses were restructured to improve the understanding an application of the clause (e.g. 8.3 Control of Nonconforming Product and clause 4.2.4 Control of Records).
  • ISO 9000:2005 Quality Management Systems — fundamentals and vocabulary defines terms. Many of the requests for clarification were already included in ISO 9000 (e.g. review, verification, and validation as they apply to design).
  • Notes were leveraged to explain requirements where there was a lack of understanding. Clause 0.1 states "Information marked "NOTE" is for guidance in understanding or clarifying the associated requirement". By using notes, changes to text in the actual clauses could be minimized (e.g. notes in clause 4.1 related to outsourcing).

      Even with the cautions that the technical experts took with amending ISO 9001, there have been some questions on the meaning behind some of the changes in the amendment. The two most frequently asked questions relate to the phrase "statutory and regulatory" and the appointment of a management representative.

      Statutory and regulatory. The words "statutory and" were added to the word "regulatory" in clause 0.1 Introduction. Users have inquired as to what actions need to be taken because of this change. In reality, this change was made simply to be consistent in the standard. The words "statutory and regulatory" were used in clause 7.2.1 while only "regulatory" was used in 0.1. This change was simply to be consistent between the two clauses. If you were correctly applying the requirements in 7.2.1, this change should not impact you.

      Appointment of a management representative. Top management shall appoint a member of the organization's management. This change was made to emphasize that the management representative should be a member of management. However, this change has raised the question of whether consultants serve as the management representative. This change does not mean that a consultant cannot serve as your management representative; however, they need to be actively engaged. If your management representative is a consultant that works at the organization at least part-time, this should not be an issue. If your management representative only works for the organization at the time of internal audits, management reviews, and third party audits, it would be difficult to demonstrate that this person is a member of the organization's management. Implementation of this requirement will be considered on a case-by-case basis. However, if you use a consultant as your management representative, you need to be able to demonstrate that the consultant is actively engaged.

      Based on the number of questions, it appears that the amendment has been fairly well understood. However, organizations need to make sure they have made the migration by November 2010. What do you need to do if you have not made the migration? The most important thing is to make sure you have a copy of ISO 9001:2008 and review Annex B to analyze to see if any of the changes affect your organization. Management Review provides an excellent forum for discussing the amendment with leadership. You also need to discuss with your certification body any migration requirements they might have and ensure you are going to meet the deadline.

      Informative Webinar
      If you need further education on the ISO 9001:2008, ASQ (American Society for Quality) is offering a free webinar on April 21, 2010 at 1 p.m. CST. Jack West and Charles Cianfrani will explain the major changes and answer participant's questions. Registration is available at
      http://www.asq.org/webinars/iso-9001-2008-explained.html. ASQ's Knowledge Center also has many articles on ISO 9001 as well, http://www.asq.org/knowledge-center/iso-9001/index.html.

      While there is not an expectation that there will be a gridlock as there was with the 2000 version of the standard, you want to make sure you avoid any scheduling issues with your certification body by ensuring that you meet the November 2010 deadline. You may have waited to make the migration for sound business reasons, but now is not the time to put it off until tomorrow.

      Contact: American Society for Quality (ASQ), P.O. Box 3005. Milwaukee, WI 53201-3005 800-248-1946 or 414-272-8575 fax: 414-272-1734 Web:
      http://www.asq.org
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