ISO 9001:2015 – Newsletter – Issue 13



Issue 13 – Clause 4.3:  Determining the Scope of the Quality Management System


ISO 9001:2015…

Clause 4.3:  Determining the Scope of the Quality Management System


What’s new in Clause 4.3?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 12) we discussed the term “interested parties” which was found in the previous Clause, and now here in Clause 4.3 we are introduced to the topic called “scope”.  The term “scope” was previously found in the 2008 version, in Section 1.0, but in that case “scope” was referring to scope of the document (the International Standard).  In the 2015 edition, Clause 4.3 is brand new in the Standard since it deals with the “scope” of your organization’s quality management system (QMS).  Although the 2008 version did not have a “shall” requirement regarding “scope”, the ISO Certification Bodies required that it be stated on the certificate they issued to you, so they mandated that you define what your “scope” was within your QMS.  This necessitated having the exact same wording shown somewhere, and in most cases companies placed it within their Quality Manual.

Let me start by making an observation regarding Clause 4.3… notice that this is the first time where the term “documented information” surfaces.  Since there is no specific requirement for a document called the Quality Manual, organizations will need to decide where to “maintain this documented information”.  Once again, I suggest that you retain your Quality Manual for many reasons as stated previously (see Newsletter Issue #3), and that this be where your company defines the boundaries or “scope” of your QMS.


The new numbering format… 

Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement


Clause 4.3: Determining the Scope of the Quality Management System –  Any company that is currently registered to the 2008 version will have a “scope” statement somewhere in their QMS.  With that in mind, let me highlight what is new for 2015.  First of all, Clause 4.3 a) & b) asks your organization to consider what was stated back in Clauses 4.1 (Context) and 4.2 (Interested Parties) when determining what your “scope” statement will be.  I believe this is somewhat backwards since it is simpler to start with defining your “Scope” and then let that drive a determination of who the relevant “interested parties” are, as well as what the internal context issues are, and what the external context issues are.  Secondly, the Standard now asks you to specifically list the types of products and services that will be included within your QMS.  Developing a list of products, and also a list of services, will be an excellent exercise to better understand what gaps exist within your current QMS.  The expectation is that each item listed (each product and each service) will be assessed and addressed using the 400+ shalls within the 2015 Standard… don’t underestimate the impact this will have.  As a Customer why would you expect anything less?

Clause 4.3 also contains requirements regarding “Not Applicables” which I discussed back in Newsletter Issue #3.  What is different here is that you are allowed to take a NA on any Clause within the Standard.  However you will have to justify that by excluding a Clause this will have no impact on your ability to provide conforming products AND conforming services, AND it will have no impact on the enhancement of satisfaction levels of your Customers.  Another way to view this is if you decide to take a NA for a particular activity that you currently do then that implies that the activity/process can behave inconsistently/ erratically/ chaotically, and yet have zero impact on the quality of your products, or the quality of your services… and the Customer will never notice it.  Having said all of that, it will be interesting to read what justifications are stated within a QMS, since this information must be maintained as “documented information”.



Be sure to watch for our next Newsletter issue where we will cover another section of ISO 9001:2015…


PS: Don’t forget to look at the Q&A section below for some final thoughts…


To view all of our past Newsletters or to sign up to receive them… click here



Need Training?

ISO 9001:2015 Essentials + Gap Audit

This combines the ISO 9001:2015 Essentials Session with a Gap Audit – This approach is used to assist organizations in launching their transition efforts for this new ISO Standard. This event accomplishes two things: a) it provides education on the new ISO 9001:2015 Standard for your key personnel (i.e. internal auditors; etc.), by highlighting the differences from the 2008 version; and b) assesses the gap from where you are today to where you need to be to achieve compliance to this new ISO Standard. Training certificates covering education on the new ISO 9001:2015 Standard, as well as issuing of a Gap Audit Report for distribution to your Top Management, are the two deliverables from this event. On a final note, a closing meeting can be arranged with key individuals so they can hear first hand the results of the Gap Audit that was performed.  PS: We’ve also done this session with just the QMS Management Rep attending, which allowed them to quickly get up to speed on this new Standard, as well as to see how much of an effort the transition will be… and of course they receive their own Training Certificate as part of this event.  This also allowed them to avoid traveling offsite to get the training they needed anyways, as evidence for their Certification Bodies.



Q:  How do you perform a gap audit for Clause 4.3 of ISO 9001:2015?

A:  For Clause 4.3, a Gap Audit checklist should cover these areas:

–  Has the organization determined the Scope of its QMS?  Where is that documented?
–  How was Context of the Organization (Clause 4.1) considered when defining the Scope Statement?
–  How were Interested Parties (Clause 4.2) considered when defining the Scope Statement?
–  Does the Scope Statement identify the types of products that are included?
–  Does the Scope Statement identify the types of services that are included?
–  Were any Clauses considered to be Not Applicable to the organization?  If yes, is the justification for doing so documented?  Where?
–  Do the justifications describe why conformity of products and conformity of services will not be affected?  Is it made clear why Customers will not be impacted?

(Make sure to obtain examples for each of the items listed above)


Until next time…

Tim Renaud

Helping Business Professionals Reduce Risk and Remove Waste!