NEW SERIES! ISO9001 for 2021 Week-by-Week - Week 2 Scope, Normative References and Terms and Definitions

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).

ISO9001:2015 begins with the usual explanation of “Scope”, “Normative References” and “Terms and Definitions”. Let’s break them down one-at-a-time.

1 Scope – the ISO standard takes a moment to introduce itself and explain the potential applicability to a business. It clearly states what “it IS” and what “it IS NOT”. It explains that it is generic and intended to be universally applicable to many different types of organizations. We should keep this in mind as we will be tasked later with identifying the scope of our own quality management system. We will have to clearly define what it DOES and DOES NOT apply to within the context of our businesses. We can take a cue from the ISO 1 Scope statement – "define the boundaries or draw a line around the QMS".  Does your business have certain divisions, business units or functions that will NOT fall under the scope of your management system?  Sometimes, this can be a physical location - like an obsolete equipment warehouse.  Or it may be a specific function, like design & development.  If your company makes product to spec or to print, you may not be doing any design or development.  Or it may be a specific business unit - like a specific industry - consumer products that may have other quality system requirements and may function completely differently than the rest of your business.  This is the context and meaning of SCOPE.  It's very important to understand your own intentions around this, as this will be your own "self-inflicted" boundary around where your QMS MUST comply with ISO9001 if you're pursuing certification. 

2 Normative References – this is easy – there ARE no normative references in ISO9001:2015.. This was added simply as a number alignment so that all ISO standards will eventually have similar numbering.

3 Terms and Definitions – there are 69 terms and definitions included in the standard! And it is critical that EVERYONE associated with the design, development, implementation, maintenance, continual improvement and auditing of your QMS clearly understand each of these terms and definitions. These terms are provided to establish a framework of communication so that all parties have a common understanding of the requirements and criteria.

THIS WEEK’S HOMEWORK – Read carefully through the “Terms and Definitions”. Review your QMS and ask yourself – are these terms clearly understood by everyone? Are they specifically taught as part of our training? Does our internal audit team clearly understand these terms? Does our team and our external auditing team communicate well and understand these terms together? What improvements should I make to ensure these terms and definitions are a solid underpinning to our QMS?

Without a clear understanding of terminology, it is difficult to communicate effectively about your quality system.  And "terminology" is one of the most common complaints or struggles that people outside the "professional quality" community have.  Use this week to make whatever changes are necessary to ensure the Terms and Definitions are understood throughout your organization.

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. 

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 your New Year off to a great start and your quality system reinvigorated. 

And join me on my journey to always keep improving!