ISO9001 in 2021 Week by Week - Week 43 - 8.5.6 Control of changes

This is a 52 week discussion of ISO9001:2015. Each week, we discuss a specific clause of the ISO9001:2015 standard in detail and look for ways to trim the fat. (As a member of TAG/TC176, the committee responsible for review and revision of ISO9001, (possible revision in 2023), I’ll keep you posted on what I learn all year!)

(It is strongly recommended that you purchase a copy of ISO9001:2015  for reference).  And, be sure to do your homework!

8.5.6 Control of changes

This clause is critical and essential and the biggest risk, in my opinion to the stability of the QMS.  Changes which are not clearly communicated create confusion.  Changes which have not been adequately reviewed and vetted may be implemented and result in an undesired outcome.  Changes, in general, create instability and a robust change management process is critical to ensure changes are fully reviewed, approved, communicated, understood and validated when they are implemented.

ISO9001:2015 describes the following requirements:

“The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements.” 

The organization is required to review and control changes for all of the previously discussed “production and service provision” topics including 8.5.1 Control of production and service provision (all of the controls established in the first place), 8.5.2 Identification and traceability, 8.5.3 Property belonging to customers or external providers, 8.5.4 Preservation and 8.5.5 Post-delivery activities.  So, just as the QMS must have defined each of these items, any changes to them must be controlled.

Additionally, any changes to the overall business, its processes, structure, scope, applicability, etc are also subject to a robust change management process.

“The organization shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.” 

The interesting point here is that while this clause requires the above listed components of the QMS be protected during changes, and the changes be documented, but not all of the items that would be expected to fall under an umbrella of a structured change management process are necessarily required to be documented in the first place.  Therefore, the organization must determine the most effective way to retain documented information of changes, whether the issue was initially documented or not.

THIS WEEK’S HOMEWORK

Review your QMS and determine where each of the bullets in this clause is determined.  Then, follow the trail to determine whether you have “documented information” regarding changes to any of those areas.  Review your change management process to ensure it includes the requirements of ” results of the review of changes”, “the person(s) authorizing the change” and “any necessary actions arising from the review”.

The trickiest part of creating a change management system is making it robust, but flexible and easy to manage.  Be sure to evaluate your change management system to see whether it is working to ensure that changes are effectively managed AND that it is easy to use.  Be sure your change management system isn't "death by signoff".

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Do you need help with your Change Management process to comply with these requirements?  Connect with us today and we'll help you create a robust but simple change management program that will be easy to manage, but powerful in terms of ensuring you have adequate controls over changes which may impact your quality system. 

But, if you’re ready for more - if you’re ready to TRANSFORM your organization, we can team up LIVE or VIRTUAL for IMPLEMENTATION of ANY or ALL ISO9001 Clauses.  We’ll lead your team and build a fully compliant foundation for your quality system so you and your team can understand the requirements and have the confidence to continue forward on your ISO9001 journey toward BETTER QUALITY.   World Class Quality, ISO9001 certification, lower costs and higher yields are just the beginning of the benefits of a robust quality system.  Connect with us today and LET'S GET STARTED!

Watch this 3-minute video about another great resource to accompany this series.   Get the self-directed, on demand, online learning series  ISO9001 in Plain English, today and you'll get:

• A clear understanding of the requirements of ISO9001:2015
• Proven tips to build a robust quality system that's easy to use
• Ways to reduce documentation and paperwork (yes, really!!)

Each video is about 15 minutes and targets a specific element of ISO9001, (with over 6 hours of total content!).  We translate all the gobbledegoop into Plain English you can understand and leverage the requirements to get maximum VALUE from your quality efforts. 

For a deeper dive into the process side of your quality system, get Tribal Knowledge - The Practical Use of ISO, Lean and Six Sigma Together, a simple guide to UNITE ISO9001, lean and Six Sigma to create a robust quality system with better results.  Read what ASQ American Society for Quality – Quality Progress Magazine had to say about it. 

Or for targeted, personalized support and coaching, let’s partner together to talk through your issues, learn more about specific tools and applications and enrich your personal development through professional coaching.  Available weekly, monthly or whatever best suits your needs!

We look forward to continuing this YEAR LONG journey with you.  SUBSCRIBE today and the series will come to you weekly to get you off to a great start and your quality system reinvigorated.