ISO9001 in 2021 Week by Week - Week 46 – 9.1.1 Performance evaluation

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!

9 Performance evaluation

9.1.1 General

We are starting to enter the place where organizations can lose their way and ultimately miss out on the intended value they’re looking for when they decide to pursue certification to ISO9001 in the first place.  I’ve seen companies write documentation and do internal audits and have records and forms and create all kinds of “audit prep” evidence.  But in the end, they are disappointed that they didn’t see the real gains they expected by having this type of quality management system.

Performance evaluation is key, and a very deliberate approach is necessary.  These requirements are intended to ensure the organization strategically decides what to measure so that it will be able to evaluate whether the system is working to achieve the organization’s objectives.  Previous versions of the standard have been often interpreted to be very prescriptive in that a user may jump right to management review “inputs” and “outputs” or internal audits or other areas suggested by the standard.  This clause, in how it is now written, simply tells the organization to take a pause and really define what is trying to be achieved by the quality system.

It really is a “no brainer”, but it has so often been skipped.

“9.1.1 General

The organization shall determine:

a) what needs to be monitored and measured;” 

 This is so simple, it shouldn’t need mentioning, but alas, the requirement is there.  It is just so elegant in its simplicity that it makes the point and reminds the organization that this is about them, not about compliance.

 b) the methods for monitoring, measurement, analysis and evaluation needed to ensure valid results;” 

This is actually my favorite item in this clause.  And I hope it gets the scrutiny it deserves.  One of the areas where many systems break down is when it comes to the validity and legitimacy of results.  I’m sure everyone reading this has had the experience during problem solving, lean or Six Sigma projects, management review, etc of having the people involved arguing about the validity of the results.  It is very important to take this step of carefully choosing (and everyone buying into) the method for measuring performance.

c)  when the monitoring and measuring shall be performed;

d)  when the results from monitoring and measurement shall be analyzed and evaluated.” 

This is important to work out so that a reaction plan can be made to respond to results.  This helps ensure that feedback is provided appropriately, and as actions are taken, their effect can be shown.

“The organization shall evaluate the performance and the effectiveness of the quality management system.” 

I especially like this point as well and how many times I’ve seen it missed!  When all is said and done, the organization must ask itself, “Is this working?”  If it doesn’t, it misses the point altogether.  For example, I’ve seen companies carry out management review faithfully and regularly, but merely repeating the same performance to themselves over and over and never really getting anywhere with the whole lets-see-some-real-improvement thing.   We must review the results we’ve obtained and make a decisive declaration about the effectiveness of the system.

“The organization shall retain appropriate documented information as evidence of the results.” 

Keeping records of this would obviously be important so that trends can be monitored and improvement opportunities can be spotted.

THIS WEEK’S HOMEWORK

Have a look at your organization’s method for performance evaluation.  Is it comprehensive?  Are the right things being measured?  Is it telling you something?  Is everyone on the same page about what it’s telling you?  Does everyone agree on the validity of the data?  This type of activity is obviously a good fit for a strategic business planning meeting and it’s that time of year when many companies are looking forward to their next business year.  Take the opportunity to align this and be sure your business goals include and agree with your quality system goals and get ready for a great 2022!

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• A clear understanding of the requirements of ISO9001:2015
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• 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. 

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