ISO 9001:2015 – Newsletter – Issue 64



Issue 64 – Clause 10.1:  General (Improvement)


ISO 9001:2015…

Clause 10.1:  General (Improvement)


What’s the intent of Clause 10.1?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 63) we discussed the topic of “management review”, and now here in Clause 10.1 we address the area of “improvement” of your QMS.  The intent of this Clause is that the organization will identify and select opportunities for improving Customer satisfaction.

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, gap audits and internal audits, where the requirements of the Standard have to be interpreted and applied to each unique situation.  A popular training request is our on-site Internal Process Auditor Training for ISO 9001:2015 since you will need to do a complete round of internal audits to the new Standard prior to your external upgrade audit.  On that note, some organizations are opting to use an outside resource to assist with their internal audits in order to meet deadlines (…more details on this service, as well as the training sessions 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…


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.

What’s new in Clause 10.1?… improvement activities aimed at the Customer are not new since it was in 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?

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 2015 version, it appears it still exists in Clause 10.1 (b) with the phrase “…preventing …undesired effects“, because isn’t that just another way of saying “preventive action”?

Finally, Clause 10.1 (c) asks that organizations also improve the performance and effectiveness of the QMS, which unfortunately is a duplicate requirement since that is what Clause 10.3 is all about… go figure.

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 can do it for you OR with 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 the Internal Audit requirements in the ISO Standards.  We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with your Team of internal auditors, we complete the entire audit together.  This latter approach allows your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.



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.



Q:  How do you perform an audit for Clause 10.1 of ISO 9001:2015?

A:  For Clause 10.1, an Audit Checklist should cover these areas:

–  Has the organization selected and 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 products and 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?
–  What improvement initiatives has the organization implemented to improve the performance and effectiveness of the quality management system? Examples?

(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!