ISO9001 in 2021 Week by Week - Week 7 - 4.4 Quality management system and its processes

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 from our quality management systems. (As an added bonus, I’m now a member of TAG/TC176, the committee responsible for review and revision of ISO9001, which is in discussions for a 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!

Oh Boy!  This week, we’re talking about 4.4 Quality management system and its processes!  We’re really starting to get into it now.

LAST WEEK’S HOMEWORK was to “Describe the scope of your quality management system with specific definition of your organization’s products and services, relevant interested parties (both internal and external) and the REQUIREMENTS of those interested parties.”

Well, how did that go?  Did you find your boundaries???  Were you able to make a clear statement of what your organization does, what its context is and what requirements its QMS is designed to ensure it can meet?  CONGRATULATIONS!  You’ve successfully defined the “WHAT” of your QMS.  Now, let’s talk about the “HOW”.

Q. How does your organization fulfill its requirements?  A. It fulfills them through the use of processes. 

Clause (4.4) provides very clear guidance on the concise construction of an effective QMS by providing a list of “shalls” that should be addressed when defining the infrastructure, or “HOW”, of your QMS.  (NOTE:  there IS also a requirement at section 4.4.2 identifying it as required “documented information”, so we need to write it down.  This may or may not be a quality manual or other document – it might be a video, series of graphics or other media – that’s your choice, but a clear definition of your processes should be kept on hand). 

In a very logical order, the “shalls” include

• first – a list of the processes used,
• then the inputs and outputs (so that they link to each other),
• then their sequence (to show how they interact),
• then the requirement of metrics to ensure whatever we determine to be a KEY process, also includes a KEY indicator to tell us if it’s working! 

Once we say what our processes are and how we’ll keep our eye on them, we must be sure the processes are properly resourced and are assigned to someone who can champion them. 

Further, we should know our processes intimately and understand their vulnerabilities (risk) and take steps to preemptively avoid those risks wherever we can.  Through responsible design (considering and mitigating as many risk factors as possible), we will operate and monitor the processes.  Then, should we fall short of our acceptable operating condition (our goals/indicators), we will have a clear plan of what to do about it.  And finally, when all else is moving along smoothly, we will challenge ourselves to continually improve.

So, how do we put it all together and maintain it going forward?

You might start by mapping out your processes start to finish, including their interaction.  Be sure to consider the main clauses in ISO9001 as management processes, as well as, your operational processes.

Q. How can I make this “documented information”?  A. Any way you like. 

You can make a business plan.  You can make a diagram.  I like to use a hybrid process flow diagram with subprocesses to describe the structure of a QMS.  You can even add additional annotations like RISK points and/or value-stream-map-like annotations to indicate my acceptable metrics/assignment of responsibility/CAPA or CI plans, etc.  Get creative!  How can you paint a clear picture to describe your organization, the quality system and how everything works? 

This part of your structure will plot the course for the future of your system.  You might include this as a map in your quality manual.  You may choose to post it as a visual reminder and roadmap to the business and use it often in group meetings, problem solving sessions and kaizen events.  It is a “living” map of how things are done and it helps keep what’s important out front!

THIS WEEK’S HOMEWORK

Identify the processes used in your organization to fulfill your internal and external customers’ requirements.  HINT:  Use the main clauses of ISO9001:2015 to guide you, but be sure to personalize each area to show how your organization operates.  This is the ultimate cornerstone for your entire system, so do your best work on this!  Feel free to post your questions, or contact me directly for support.  GOOD LUCK!

THIS WEEK’S FREE STUFF!  FREE DOWNLOAD!  Here’s an example to help with this week’s homework.  Use the form below to get a FREE example of an overall Process Interaction Map.

And for MORE GREAT RESOURCES, watch this 3-minute video about my online course, ISO9001 in Plain English, which is a perfect accompaniment to this series.  Get 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 in the series 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. 

We look forward to taking 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. 

And join me on my journey to always keep improving!