Issue 66 – Clause 10.3: Continual Improvement
Clause 10.3: Continual Improvement
What’s the intent of Clause 10.3?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 65) we discussed the topic of “problem solving”, and now here in Clause 10.3 we address the area of “continual improvement” of your QMS. The intent of this Clause is that the organization will identify and select opportunities for improving your Quality Management System (QMS).
Note A: Although this is the LAST Clause of this new Standard, it is not my last Newsletter. Starting next month I will be answering the many questions that I get from Readers of my Newsletters about how to implement the requirements of ISO 9001:2015 in a specific and practical way, that will also help improve business performance. 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, 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 10.3: 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 64), 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 I will be answering the many questions that I get from Readers of my Newsletters about how to implement the requirements of ISO 9001:2015 in a specific and practical way, that will also help improve business performance…
PS: Don’t forget to look at the Q&A section below for some final thoughts…
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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.
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 10.3 of ISO 9001:2015?
A: For Clause 10.3, an Audit Checklist should cover these areas:
– What improvement initiatives has the organization implemented to improve the suitability, adequacy and effectiveness of the quality management system? Examples?
– When determining if there are needs or opportunities for continual improvement has the organization taken into consideration the results of analysis and evaluation, and the outputs from
management review? Examples?
(Make sure to interview more than one person and obtain examples for the items listed above)
Until next time…
Helping Business Professionals Reduce Risk and Remove Waste!