ISO9001 for 2021 Week by Week - Week 6 - 4.3 Determining the scope of the QMS

This is a 52 week discussion of ISO9001:2015. We challenge you to follow us each week, and review your QMS from top to bottom with us. 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. By year end 2021, you can have your QMS revitalized!  (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!)

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

Do you know your quality system’s boundaries?  This week, we put together our previous discussions about why our organization exists (its mission and strategy) and what our context is (where and how we fit into our industry and community).

Now, it is time to put pen to paper (or other media, as it were) and to establish as “documented information” the scope of the quality management system.  Clause 4.3 specifically defines what “shall” (or must) be considered when determining the boundaries or scope of the QMS.  This is where we begin to put together all of the things we’ve discussed so far, including what we discussed in Week 4 “4.1 the organization and its context” as well as what we discussed in Week 5 “4.2 the needs and expectations of interested parties”.

As we create this scope statement “as documented information”, we must specifically identify the products and services covered by the QMS and justification where anything in the ISO standard may not apply. 

Once we have clearly established our context, who our interested parties are and their needs and expectations, and what the QMS will apply to (scope), we can then move onto identifying what processes we’re going to use to meet those needs.  The framework for our entire QMS is beginning to come together. 

THIS WEEK’S HOMEWORK

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.  After all, the whole reason for having a QMS is to create a system for ensuring the organization can meet those requirements.

FREE STUFF!  Download a FREE list of Sample Scope Statements to help you get started.  Click the form below.

MORE FREE STUFF!  This series is packed with FREE STUFF!  If you haven’t already, go back to Week 4 or Week 5 and get your free SWOT Analysis Template. 

Watch this 3-minute video about a great resource to accompany 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 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. 

DON'T MISS OUT!  Get a FREE PREVIEW of ISO9001 in Plain English which includes this week's section 4.3!

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. 

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!