Issue 109 – Why review QMS documents if nothing has changed?
ISO 9001:2015…
Why review QMS documents if nothing has changed?
I appreciate receiving emails with questions and/or comments from readers of this Newsletter… please continue to do so since it provides me with direction on where to aim the content of these publications. In my last Newsletter (ISO 9001:2015 Newsletter Issue 108) we discussed the topic of “Does ISO Re-Certification mean you can take a 3 year break?”, and now in this Newsletter we will discuss “Why review QMS documents if nothing has changed?”.
The ISO 9001:2015 Element numbering…
Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement
So why do QMS documents need to be reviewed if nothing has changed?… When this question arrived in my Inbox it was harder to answer than I first anticipated. The reason why it was more difficult is because I incorrectly assumed that there was an explicit “shall” requirement in the ISO 9001:2015 Standard dealing with this… however in reality I was thinking of the wording found in the 2008 previous version of the Standard, Clause 4.2.3(b) which said: “to review and update as necessary and re-approve documents”. The current version (ISO 9001:2015) replaced that wording with something softer, now found in Clause 7.5.3.1, which states: “Documented information… shall be controlled to ensure… (a) it is available and suitable for use” …and that a record be kept as evidence of this “suitability”. The intent being that PRIOR to the Employee using a Procedure (no matter how old it is), that it is confirmed as “suitable” to use.
For the reasons stated above, that is why many companies choose to put an expiry date on their Procedures to force a review after a certain amount of time has passed. I believe that most organizations have implemented “a periodic review” of their Quality Procedures (and have done the same with their Safety Procedures) in order to minimize the risk of an Employee not using a current method when performing their job responsibilities… they look at this “periodic review” approach as a good business practice for both their company, and their Customers.
This “alternative approach” is much too cumbersome which is probably why most organizations choose a “periodic review” or “expiry date” approach rather than taking a chance (risk) that an old Procedure is mistakenly followed. By the way, I’ve seen expiry dates range from 1 year, 2 years and 3 years… and I’ve also seen different expiry dates used for different Procedures.
One last comment… over the last 29 years that I’ve conducted audits, out-of-date documents (that don’t reflect current practices) is the most common problem that is found… and if I surveyed other Auditors, I am fairly confident they would agree… the message being that even after using a “periodic review” approach, some documents continue to be incorrect, so imagine how many more QMS documentation problems would surface without it!
Be sure to watch for our next Newsletter issue where I will be answering some of the questions that I get from Readers of my Newsletters about how to implement the requirements of ISO 9001:2015 in a specific and practical way, that will also help improve business performance…
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Need Help?
ISO 9001:2015 Internal Audit Outsourcing (we can do it for you OR with you!)
For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy the Internal Audit requirements in the ISO Standards. We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with your Team of internal auditors, we complete the entire audit together. This latter approach allows your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.
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Internal Process Auditor Training for ISO 9001:2015
The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session is focused on a process approach to auditing with the objective being not only to assess conformance of the quality management system, but also to uncover process improvements during an audit. This goes hand in hand with the process auditing requirements found within ISO 19011 and the process approach covered in ISO 9001:2015, which promotes continual process improvement throughout this Standard. An enhanced checklist is developed, and there will be workshops throughout, to reinforce learning, as well as a live, practice audit. If you are looking to meet the ISO 9001:2015 internal audit requirements and to “raise the bar” for your internal audit program then this is the course you should consider.
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Until next time…
Tim Renaud
Helping Business Professionals Reduce Risk and Remove Waste!