ISO 9001:2015 – Newsletter – Issue 38



Issue 38 – Clause 10.3:  Continual Improvement


ISO 9001:2015…

Clause 10.3:  Continual Improvement


What’s new in Clause 10.3?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 37) we discussed the topic of “nonconformity and corrective action”, and now here in Clause 10.3 we address “continual improvement”.

Note A:  Although this is the LAST clause of this new Standard, it is not my last Newsletter.  Starting next month I will be going back to the beginning of the ISO 9001:2015 Standard and discussing each Clause in its entirety (not just what’s new, but everything inside of it)… including a complete list of auditor checklist questions.  My hope is that you will continue to find these Newsletters useful, and if so, that you will share them with others!
Note B:  This Clause DOES NOT include requirements for “documented information”.
Note C:  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 workshops 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 9001:2015 Essentials Training, has become our most popular request for proposal from our Newsletter readers.  Another popular training request is our on-site Internal Process Auditor Training for ISO 9001:2015 (…more details on these training sessions, as well as other training that we offer, can be found below).
Note D: ** This year, 2017, marks a milestone for our organization. Twenty-five (25) years ago we began offering our auditing, training and consulting services to our Clients.  We very much appreciate the support that our Clients have shown over these past many years and are humbled by the trust they’ve put in us!  As always, we look forward to helping our Clients continue to find more ways to improve their business systems. **


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 10.3  Continual Improvement) consists of zero (0) Sub-Clauses…

The concept of continual improvement was found throughout the previous 2008 version of this Standard.  As such, the requirements here in Clause 10.3 are very similar but as I pointed out in a previous Newsletter (see ISO 9001:2015 Newsletter Issue 36), the target of this Clause is the QMS itself.  Organizations are being asked to implement a process that will continually improve the suitability, adequacy and effectiveness of their quality management system.

There is one area in Clause 10.3 where new words have been added… it is found in the last sentence: “…the organization shall determine if there are needs… that shall be addressed…” as part of the continual improvement process.  Even though this is a new requirement, I don’t see much difference between the word “needs” and the word “opportunities”, and the objective evidence you’d offer up would likely be the same in any event.


Be sure to watch for our next Newsletter issue where we will go back to the beginning and cover each Clause of ISO 9001:2015 much more thoroughly…


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


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Need Help?

ISO 9001:2015 Internal Audit Outsourcing (we do it for you)

For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy Internal Audit requirements within the ISO Standards.


Documentation Development Training Workshop for ISO 9001:2015

This Documentation Development Training Workshop for ISO 9001:2015 Session is intended to be a very interactive, hands-on session (hence the name Workshop) where your QMS documentation will be created/revised, with guidance from an experienced facilitator.  This type of session can help launch your transition efforts by getting a lot accomplished within a compressed time-frame.  If your organization has already begun the re-write then this session can be used to validate what you’ve accomplished so far, or if you haven’t yet begun, it can be the catalyst to get things started (…which is usually the hardest part).  Deciding how to move from your current QMS structure into a new one can be a daunting task and this session can help you navigate through it.  A copy of a sample Quality Manual (re-iterating the “shall” requirements found within the ISO 9001:2015 Standard) will be provided to each participant.  As always, our focus will be on how to develop a simplified and streamlined quality management system, that helps to drive improvement in your business.


Internal Process Auditor Training for ISO 9001:2015

The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session 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 10.3 of ISO 9001:2015?

A:  For Clause 10.3, a Gap Audit checklist should cover these areas:

–  There are essentially no new requirements within this Clause therefore no gap should exist in your current QMS


Until next time…

Tim Renaud

Helping Business Professionals Reduce Risk and Remove Waste!