ISO 9001:2015 – Newsletter – Issue 14



Issue 14 – Clause 4.4:  Quality Management System and its Processes


ISO 9001:2015…

Clause 4.4:  Quality Management System and its Processes


What’s new in Clause 4.4?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 13) we discussed the topic of “scope” which was outlined in the previous Clause, and now here in Clause 4.4 we cover the whole of the QMS, along with its processes.


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 4.4 Quality Management System and its Processes consists of two (2) Sub-Clauses as listed below:

4.4.1  [no title]  The organization shall establish, implement…

4.4.2  [no title]  To the extent necessary, the organization shall…


Sub-Clause 4.4.1 –  This area was covered in the very first lead-off Clause previously found in the 2008 version.  In the 2015 edition, this Sub-Clause adds a few new requirements, the first being Sub-Clause 4.4.1 a) which asks the organization to determine the inputs and outputs of the processes needed for the QMS.  The second being Sub-Clause 4.4.1 c) where performance indicators need to be identified for these processes.  The third is Sub-Clause 4.4.1 e) which asks you to assign who is responsible, and who has the authority over each of these processes. Finally, in Sub-Clause 4.4.1 f) a new requirement asks how these processes will address the risks and opportunities identified in Clause 6.1.


Sub-Clause 4.4.2 –  This is the sub-clause that provides you with the flexibility to decide how much, or how little, documentation your QMS needs, to function effectively.  Sub-Clause 4.4.2 a) uses the term “maintain documented information” and Sub-Clause 4.4.2 b) says “retain documented information”, and these terms are translated for you in Annex A.6 whereby “maintain” is equivalent to the old “control of documents”, and “retain” is the same as “control of records”.



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…


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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 4.4 of ISO 9001:2015?

A:  For Clause 4.4, a Gap Audit checklist should cover these areas:

–  Has the organization determined the inputs and the outputs for each of the processes within its QMS?
–  Have performance indicators have been identified for each of the QMS processes?
–  Have authorities and responsibilities been assigned to each of the QMS processes?
–  How do the QMS processes address risks and opportunities (ref Clause 6.1)?
–  How does the organization decide what QMS activities need to have controlled documentation in place (ref 4.4.2a)?
–  How does the organization decide what records need to be retained as proof that the QMS is functioning properly (ref 4.4.2b)?

(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!