Issue 114 – ISO 9001:2015 Clause 10.1 and Clause 10.3, what’s the difference?
ISO 9001:2015…
Clause 10.1 and Clause 10.3, what’s the difference?
I appreciate receiving emails with questions and/or comments from readers of this Newsletter… please continue to do so since it provides me with ideas on what these publications should cover. In my last Newsletter (ISO 9001:2015 Newsletter Issue 113) we discussed the topic of “Do Vendors or Suppliers need to be ISO certified?”, and now in this Newsletter we will discuss “ISO 9001:2015 Clause 10.1 and Clause 10.3, what’s the difference?”.
The ISO 9001:2015 Element numbering…
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
What’s the difference between Clause 10.1 (Improvement – General) and Clause 10.3 (Continual Improvement)?… This exact question came up during a recent internal audit… and at first glance, the answer is… not much. On the surface Clause 10.1 looks very similar to Clause 10.3… 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 Quality Management System (QMS). Some of your improvement initiatives may make your QMS stronger but it better also get your Customer excited, in order to satisfy the requirements within Clause 10.1 (Improvement – General). Ask yourself these questions: “Has your organization selected and implemented opportunities for improvement that are aimed at the Customer? Has Customer satisfaction been enhanced as a result? Any Customer examples?
Clause 10.3 (Continual Improvement), on the other hand, is asking your organization to implement a process that will continually improve the suitability, adequacy and effectiveness of your Quality Management System (QMS)… and “Yes” you can use the same examples for Clause 10.3 as you did for Clause 10.1… but you can’t do the reverse. Why not?… because any examples of improvement will work for Clause 10.3 but to satisfy the requirements of Clause 10.1 the improvement needs to directly impact (or excite!) your Customer.
As a final comment… Keep in mind that since most organizations set targets and goals on an annual basis, this activity can be used as evidence of a “continual improvement process” as required within Clause 10.3… but what if you don’t achieve all of your targets or goals every year? In most cases, at least one example can be found to satisfy Clause 10.3. By the way, not always meeting targets/goals is the reality of being in business in a marketplace crowded with competition… so having insufficient evidence to address Clause 10.3 will be the least of your worries!
Be sure to watch for our next Newsletter issue where I will be answering some of the 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…
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Need Help?
ISO 9001:2015 Internal Audit Outsourcing (we can do it for you OR with you!)
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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.
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Until next time…
Tim Renaud
Helping Business Professionals Reduce Risk and Remove Waste!