ISO 9001:2015 – Newsletter – Issue 36



Issue 36 – Clause 10.1:  General


ISO 9001:2015…

Clause 10.1:  General


What’s new in Clause 10.1?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 35) we discussed the topic of “management review”, and now here in Clause 10.1 we move into the last Element 10.0 (Improvement) and address the first Clause within it, dealing with “improvement – in a general sense”.
Note A:  This Clause DOES NOT include requirements 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 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).


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 10.1  General (Improvement) consists of zero (0) Sub-Clauses…


Let me begin by saying that on the surface Clause 10.1 looks very similar to Clause 10.3 (Continual Improvement)… so similar in fact that you will be tempted to show the exact same objective evidence, to satisfy the requirements in both of these Clauses.  There is however a distinct difference, and no, I’m not referring to the word “continual” (found only in Clause 10.3).  What I am alluding to is the difference of where the “improvement” is aimed at in these two Clauses.  The first sentence of Clause 10.1 provides the answer: “The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction”.  The Customer is the target of this Clause, whereas in Clause 10.3, the target is your QMS.  Some of your improvement initiatives may make your QMS better but it better also get your Customer excited, in order to satisfy the requirements within this Clause.

So let’s get back to the question of what’s new in Clause 10.1… improvement activities aimed at the Customer is not new since it was in the old “management review outputs” within the previous 2008 version of this Standard.  What is new are the words “…select opportunities for improvement… to… enhance customer satisfaction“.  This now raises the bar and places the onus on organizations to implement a process for identifying improvements that will raise the level of satisfaction perceived by your Customer.

In addition, Clause 10.1 (a) has the new words “…and services“, along with “…as well as to address future needs and expectations“.  The latter implying that you will need a method or approach that will predict or uncover what your Customer expects from you in the future.  That is much easier said then done.  What is your organization’s process for detecting what your Customers will want tomorrow?

Finally, Clause 10.1 (b) has added these words “…reducing undesired effects“, which implies minimizing the damage from a process problem that perhaps can’t be permanently fixed.  On a side note, although the old “Preventive Action” Clause was removed from this new version, it appears to still exist in Clause 10.1 (b) with the phrase “…preventing …undesired effects“, because isn’t that just another way of saying “preventive action”?


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 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, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy Internal Audit requirements in 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 10.1 of ISO 9001:2015?

A:  For Clause 10.1, a Gap Audit checklist should cover these areas:

–  Has the organization implemented opportunities for improvement that are aimed at the Customer?  Has Customer satisfaction been enhanced as a result?  Examples?
–  How has the organization improved the services it provides to its Customers?  Has Customer satisfaction been enhanced as a result?  Examples?
–  How does the organization identify future needs and expectations of its Customers?
–  What improvement initiatives has the organization implemented to reduce undesired effects experienced by the Customer?  Examples?


Until next time…

Tim Renaud

Helping Business Professionals Reduce Risk and Remove Waste!