ISO9001 in 2021 Week by Week - Week 48 – 9.1.3 Analysis and 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!

9.1.3  Analysis and evaluation

This sections switches gears back to the structure of the performance evaluation system and provides a list of those things which should be monitored (again listing customer satisfaction).

“The organization shall analyze and evaluate appropriate data and information arising from monitoring and measurement.

The results of analysis shall be used to evaluate:

a) conformity of products and services;”

This first bullet is pretty obvious in that it requires we have an idea of whether our products and services meet expectation overall.  This can be the typical “nonconformances”, “errors” (internal or external), “failures”, etc.

“b)  the degree of customer satisfaction;”

This can be any number of metrics including results from surveys, complaints, complements, return customers, reorders, measures of how well your customers recommend or promote you, etc.

“c)  the performance and effectiveness of the quality management system;”

This can be any measure of effectiveness including whether the main objectives are being achieved, status of certifications, etc.

“d)  if planning has been implemented effectively;”

This can often be associated with results of audits.  Is the quality system being followed as designed?  Is it working?  It is delivering the intended results?

“e)  the effectiveness of actions taken to address risks and opportunities;”

This may be captured in audits, but should also be considered at some frequency with strategic planning activities.  The quality system should provide a mechanism for continuous monitoring of risks and tracking what actions are being taken along with the effectiveness of those actions.

“f)  the performance of external providers;”

Because vendor performance has such a potential to impact your performance, this is a key metric of the quality system. This is often captured by the procurement group in the form of vendor report cards, notifications when a vendor fails to perform, “shout outs” when a vendor goes above and beyond, etc. 

“g)  the need for improvements to the quality management system”

The quality system should provide opportunity to recognize the need for improvements.  This should not be confused with “corrective action”, as that concept is associated with a defined practice or condition failing or not being followed.  “Improvement” should be thought of something that is performing as initially intended, but has the potential to perform better, or could yield even better results. 

Not performing = corrective action

Has higher potential = improvement

“NOTE:  Methods to analyze data can include statistical techniques.”

Again, I think this note is just weird.  I shake my head as I read it and say “no kidding” to myself.  But ok, there it is.

THIS WEEK’S HOMEWORK

Watch as the next couple weeks unfold.  You’ll begin to notice that what must be measured will look a lot like what must be included in internal audits.  And THAT will look a lot like the required inputs for management review.

Review your current monitoring and measuring system.  In many cases, “management review” is where this type of data is analyzed and reported.  But before we jump into management review, take a moment to validate the data and check your team’s perception of the validity of the data.  In many quality systems, debatable data creates roadblocks to improvement.  Data must be vetted and agreed to by all to ensure performance monitoring is paid attention to and responded to. 

Also, take the opportunity to assess the types of monitoring that are being done.  Are the right things being measured?  Are they relevant?  Are they continually improving?  Are the frequencies at which they are monitored appropriate?  This time of year is, for many organizations, a great opportunity to tie in with the strategic business plan and make sure the performance monitoring methods align with the plan. 

And taking the time to simply sit with the idea of what is being measured and whether everyone trusts the data can get you a long way on trying to get your team all pulling in the same direction.  Good luck!

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Do you need help identifying what to measure and how to measure it to meet these requirements?  Connect with us today and we'll help you identify your most powerful metrics that will be easy to manage, but powerful in terms of revealing how and where to improve.  

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 're almost through this series and ready to start a new series in 2022.  SUBSCRIBE today and the series will come to you weekly to get you off to a great start and your quality system reinvigorated. 

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