FREE STUFF! ISO9001 for 2021 Week-by-Week - Week 4 - 4.1 Understanding the organization and its context

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!

4.1 Understanding the organization and its context

This is the cornerstone upon which the QMS should be built.  It helps us focus on exactly what our organization is about and how it fits in the world.  This is a simple, but important concept that some organizations skip through and as a result, their QMS can become more complicated than necessary.  (That's not lean!).  Remember last week, we took a giant step back to the very beginning and reflected on 10 questions to put "context" around our organization.  That continues to be this week's theme.  And because it is a cornerstone, we need the utmost clarity on the context of our organization.

If we understand our context (our internal and external issues), and later, our interested parties, we will also be able to easily define many of the areas of “risk” that will be targeted later in the standard. But, we’ll wait to open that Pandora’s box about “tisk” until we come to it.

The first sentence is a requirement.  Our first "shall", if you will.  Let's talk about "shalls" for a moment.  It's key to decoding the language of the standard.  Anywhere there is a "shall", it should be considered an absolute requirement for compliance.  In other words, there's really no wiggle room for an organization to determine that it is "not applicable" to them.  "Shalls" apply to all organizations and their quality systems.  The only exception is if there is a specific section of the standard that you identify as specifically omitted in the scope of your QMS.  One fairly common example is "Design & Development" for those organizations who do absolutely no design or development activities.  

So, the first requirement is that the organization "shall determine the external and internal issues that are relevant to its purpose and its strategic direction  and that affect its ability to achieve the intended result(s) of its quality management system".  So, our first step to building (or reviewing) a QMS is to intentionally determine our external and internal issues (based on the 10 questions we did as our homework last week).  

One bit of language in the requirements that I don’t love in this section are the specific requirements of “shall monitor and review the information about these external and internal issues”. There is no requirement for a record of this review, but a “shall” is a “shall”. And given the guidance in NOTE 1 and NOTE 2, the context characteristics that might be considered would almost certainly not be “monitored and reviewed”. This looks like a great place to get stuck with an auditor in the age old argument – “we (monitor and review) them” + “how do I know that?” + “we promise” + “show me”…….

Through this series, you'll come to find that there are myriad opportunities to combine and leverage your traditional quality efforts with lean and Six Sigma tools to ensure your system is as lean and tight as it can be, yielding optimal results! 

So, one tip I can give you is to think about 4.1 and 4.2 as a bundle of requirements.  And there is a very, very simple lean Six Sigma tool you can use to determine those external and internal issues, as well as the "interested parties" which comes in the requirements in 4.2.  It is called a SWOT analysis - Strengths, Weaknesses, Opportunities, Threats.  This will document the fact that you did the initial review, as well as give you an easy framework for what will be "monitored and reviewed" going forward.  

Starting right at the beginning with a SWOT analysis allows us to ensure we've identified as many external and internal issues as possible, and then add "interested parties" as part of the exercise.  And later, we can prioritize those external and internal issues into those with the highest risk, so that we can strategically target our resources toward minimizing the risk to our quality system and the products and services we offer our customers.  

LAST WEEK’S HOMEWORK
Did you gather your information about last week’s 10 questions? If so you’re ready to go.

THIS WEEK’S HOMEWORK – Use last week’s questions to determine your organization’s external and external issues.  Try using the SWOT analysis tool!  Then, see if you can clearly articulate the organization's purpose and strategic direction. Sometimes this begins with a mission statement, but whatever is appropriate to your organization will suffice. Remember, working through this section of the standard is an area where you should be aware of not adding unnecessary “fat” to your QMS. Decide who and what your organization is, then move forward accordingly with a clear focus.

THIS WEEK!  Get help with this week's homework with a FREE PREVIEW of ISO9001 in Plain English!  This 22 minute video is packed with tips and information on how to identify your context, external and internal issues and interested parties and their expectations.  

AND AS AN ADDED BONUS, get a FREE DOWNLOAD of a simple SWOT Analysis Template to get you started.  Click the form below. 

Next week, we’ll begin to use our external and internal issues, as well as our purpose and strategic direction, to identify our interested parties, which should be considered in the architecture of our QMS. Good luck!

Learn more about a great resource to accompany this series in this short video.   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 about this week's sections 4.1, with bonus sections 4.2 and 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!