ISO 9001:2015 – Newsletter – Issue 23



Issue 23 – Clause 7.3:  Awareness


ISO 9001:2015…

Clause 7.3: Awareness


What’s new in Clause 7.3?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 22) we discussed the topic of “competence”, and now here in Clause 7.3 we address the area of “awareness”.
Note A: This Clause does NOT include a requirement for “documented information”.
Note B: As some of you already know, the content for these Newsletters comes from working in the field with my Clients, and with their ISO Certification Bodies.  I gain a lot of hands-on experience from conducting training seminars and gap audits, where the requirements of the Standard have to be interpreted and applied to each unique situation.  Combining an on-site Gap Audit with ISO 9001 Essentials Training, has become our most popular request for proposal from our Newsletter readers (…more details on this, as well as other training that we offer, can be found below).


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 7.3  Awareness consists of zero (0) Sub-Clauses.

The requirements within this sub-clause are for the most part very similar to the requirements in the old 2008 version, essentially asking the organization to ensure that persons doing work under their control are aware of certain things pertaining to the QMS.  In part [b] they added the word “relevant” in front of quality objectives, which makes sense since not every person needs to be aware of every quality objective, only those they can impact.  In part [c] they want the organization to make people aware of the benefits of their “improved performance” and in part [d] has the flip side by making sure they are aware of the implications of not adhering to the QMS requirements.

I believe organizations will continue to use their existing performance review processes to address all of the requirements within this sub-clause, as well as town hall meetings and departmental status update meetings.


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?


Internal Process Auditing for ISO 9001:2015

The two (2) day Internal Process Auditing for ISO 9001:2015 Session (also covers requirements in ISO 19011) is focused on a process approach to auditing with the objective being not only to assess conformance of the quality management system, but also to uncover process improvements during an audit. This goes hand in hand with the process auditing requirements found within ISO 19011 and the process approach covered in ISO 9001:2015, which promotes continual process improvement throughout this Standard. An enhanced checklist is developed, and there will be workshops throughout, to reinforce learning, as well as a live, practice audit. If you are looking to meet the ISO 9001:2015 internal audit requirements and to “raise the bar” for your internal audit program then this is the course you should consider.


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 7.3 of ISO 9001:2015?

A:  For Clause 7.3, a Gap Audit checklist should cover these areas:

–  How does the organization ensure that its people are aware of the quality objectives that are relevant to them?
–  How does the organization ensure that its people are aware of the benefits of their own improved performance on the QMS?
–  How does the organization ensure that its people are aware of the implications of not adhering to the QMS requirements?

(Make sure to interview more than one person and obtain examples for the items listed above)


Until next time…

Tim Renaud

Helping Business Professionals Reduce Risk and Remove Waste!