Denise Robitaille
Published: Wednesday, October 2, 2013 - 11:00 As ISO 9001 wends its way through the revision process, there have been dozens of articles, webinars, forums, and discussions anticipating what the final product will look like. Pundits and experts, consultants and gurus are all weighing in on what’s going to happen. The prognosticators have made a run on crystal balls, decimating the fortunetelling industry. With all the predictions all we need is for the Vegas bookies to starting laying odds on what will or won’t be included in the next version of 9001. There is a lot of stuff out in the public domain. Some of the information that has been published is very useful. It helps us all to plan. However, lots of what’s being hawked as definitive is, at best, premature. What follows covers two things: What we currently know, and what actions are appropriate at this time. ISO 9001 is being revised. The systematic review was conducted; surveys were done and the final balloted decision was that it was appropriate and timely to revise this popular and broadly applied standard. The vote and ensuing work is intended to ensure the standard's continued relevance and usefulness in the marketplace The structure will be based on the newly approved, high-level structure technically known as “Annex SL.” This new structure for all ISO management system standards was developed by the Joint Technical Coordination Group (JTCG ). Its aim was to achieve greater alignment and synergy between various management system standards and to hopefully diminish both redundancies and conflicts that might develop when organizations are required to conform to multiple standards such as ISO 9001, ISO 13485, AS9100, and TL9000. The point here is that the standard’s structure will change, but there are no guarantees that the high-level structure and common text will be adopted verbatim. The revision process has several balloting and commenting periods interspersed with review periods that allow technical experts to develop a creditable and useful document that will serve the marketplace. The TC176/SC2 technical experts will be meeting in November 2013 to review the thousands of comments that were received during the balloting of the committee draft. The amount of comments received and the deliberations that accompany the reviews of the drafts make the likelihood of changes a foregone conclusion. Therefore, no one can say for sure what the finished product will look like. We can break this down into two categories: do’s and don’ts. Do’s: Don’t’s: And finally, heed the slice of wisdom attributed to the baseball great Yogi Berra who reminded us that: “It ain’t over till the fat lady sings. Denise Robitaille is the author of thirteen books, including: ISO 9001:2015 Handbook for Small and Medium-Sized Businesses. She is chair of PC302, the project committee responsible for the revision to ISO 19011, an active member of USTAG to ISO/TC 176 and technical expert on the working group that developed the current version of ISO 9004:2018. She has participated internationally in standards development for over 15 years. She is a globally recognized speaker and trainer. Denise is a Fellow of the American Society for Quality and an Exemplar Global certified lead assessor and an ASQ certified quality auditor. As principal of Robitaille Associates, she has helped many companies achieve ISO 9001 registration and to improve their quality management systems. She has conducted training courses for thousands of individuals on such topics as auditing, corrective action, document control, root cause analysis, and implementing ISO 9001. Among Denise’s books are: 9 Keys to Successful Audits, The (Almost) Painless ISO 9001:2015 Transition and The Corrective Action Handbook. She is a frequent contributor to several quality periodicals.
Standards It Ain’t Over Till the Fat Lady Sings
What we know about ISO 9001:2015, and what we should do now
What we know for sure
What we should do
1. Remain informed about the revision process. Things will change. And the best hedge against being surprised by the changes is current and reliable information. Since ASQ is the administrator for the US TAG to ISO TC176, articles in Quality Progress and other ASQ publications are pretty reliable because much of the material is peer reviewed. (Social media, by contrast, have little or no filters resulting in an unqualified hodge-podge of fact and opinion). You can send me questions through Quality Digest, and I’ll be happy to answer or to pass the question on to others who can respond more completely.
2. Consider the source of information on the revision. Make sure to get information from creditable sources. There are reputable individuals who have valuable information about the process, the potential changes, the rationale for those changes, and directions on how and when to make comments and voice concerns. These individuals are quite candid and forthcoming about the fact that lots of what they are talking about is subject to change. People who are either directly or indirectly involved with the standards development process are often a good resource. They know what is fact and what is conjecture. Again, you can make inquiries through Quality Digest, which will send them to me or other reliable technical experts.
3. Taking into consideration item No. 2, be especially wary of organizations offering training on how to change your system to address the impending changes. (Remember: The changes have not been definitely determined).
4. Ensure that your organization’s top managers are aware that changes are coming so that they can plan the allocation of the resources that will be needed and make necessary provisions in the budget. Once the final version is published, there is a high likelihood that some document changes will be required, and that internal auditors will need to be trained to the newly revised or additional requirements.
5. Consider joining the US TAG to ISO TC 176 so that you can participate in the process. Being a TAG member affords you the opportunity to get first-hand information about the revision process. You get to review the drafts of all active projects in the TC176 portfolio and to have your voice heard through the commenting process and the breakout sessions conducted during the twice-annual meetings. You also have the privilege of working (and networking) with extraordinary individuals who are passionate about standards and quality. Send an email to standards@asq.org for more information on how to join.
• Don’t make decisions based on the word of people who purport to have the inside track on what the ultimate revision will include. The nature of the standards development process debunks the concept of insider scoops.
• Don’t start revising your documentation. At this stage in the game, when things are still undecided, the risk of wasting resources by making needless changes is high. There will be lots of time to make needed revisions once we all know what’s going on.
• Don’t let anyone convince you that they know what will happen.
• Don’t worry—at least, not yet.
About The Author
Denise Robitaille
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Comments
ISO 9001:2015
Denise,
Thanks for your comments on this subject. Based on my review of the draft standard, some areas seem to be glossed over in the standard, some improved, and some worsened. The one thing I was hoping they would do in the new standard is say something about the need for corrective action (one of your areas of expertise) and provide at least an acknowledgement that application of corrective action was not needed for all nonconformities (failure to meet requirements). Instead, the writers of the standard did nothing to improve this area and in my opinion, made is worse in the rewording. The application of corrective action appropriate to the effects is rather meaningless and still implies that CA is needed for all nonconformities. Of course, we always argue the case as to when CA is needed, and can usually win that with an ISO auditor, but I thought the standard writers would at least consider clearing this up. Instead, the standard is not very helpful in this area and seems to validate that the mindset is the very one Deming warned us about: everything is treated as if it's a special cause. The amount of resource wasted in this is enormous. Have we learned nothing?
- Mike Harkins
Cry wolf?
Thank you for your sensible words, Mrs. Robitaille: too much has been written and said on ISO 9001:2015, too much fuss made. Even before its publishing, it's the event of the decade in our business, and it looks like it will sell even more than its ISO 9001:2000 predecessor; even more so, if we consider what is more or less officially rumored in the last year or so. The only solid brick we have is the rather recent CD, and even that is not much to build a wall: I have publicly commented it and I came to my own conclusions, that cannot be but preliminary. The only thing I have at heart is to prevent what happened in my delightful Country when ISO 9001:2000 came into force: just the day after, newspapers were full of articles informing that the car servicing network of a notorious german car maker got the registration certificate on that very day.
Memememe ... mamamamama .... moomoomoomoo