Issue 37 – Clause 10.2: Nonconformity and Corrective Action
Clause 10.2: Nonconformity and Corrective Action
What’s new in Clause 10.2?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 36) we discussed the topic of “improvement – in a general sense”, and now here in Clause 10.2 we address “nonconformity and corrective action”.
Note A: This Clause DOES include requirements for “documented information”.
Note B: 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 10.2 Nonconformity and Corrective Action consists of two (2) Sub-Clauses as listed below:
10.2.1 When a nonconformity occurs, including any arising from complaints…
10.2.2 The organization shall retain documented information…
Sub-Clause 10.2.1 When a nonconformity occurs, including any arising from complaints… – I used the first few words of this sub-clause since it has no “title” to identify it. The first place where new requirements appear is in 10.2.1 (a-2) which says: “react to the conconformity and… deal with the consequences“. This implies that organizations will do more then just control a nonconformity, but that they will look downstream to see what impact it had and then handle the consequences that arise… in other the words the domino effect of the nonconformity.
Another place where new words have been added is found in Sub-clause 10.2.1 (b-3) which asks organizations to evaluate the need for corrective action by “…determining if similar nonconformities exist, or could potentially occur“. It makes sense to look at each nonconformity to assess whether it is an indicator of recurring issues or is a hint that another problem could indeed occur, so that a decision can be made whether to escalate it into a full blown corrective action.
Sub-clause 10.2.1 (e) is new, and it asks organizations to “…update risks and opportunities determined during planning, if necessary” as a result of nonconformities that arise (go back and re-read ISO 9001:2015 Newsletter Issue 18 for help on how to handle this requirement).
Sub-Clause 10.2.2 The organization shall retain documented information… – Again, I used the first few words of this sub-clause since it has no “title” to identify it. There are no new requirements found within this sub-clause except for the new term “documented information”.
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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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.
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.
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.
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 10.2 of ISO 9001:2015?
A: For Clause 10.2, a Gap Audit checklist should cover these areas:
– How has the organization dealt with the consequences of any noconformities that have occurred? Examples?
– When evaluating the need for corrective action, does the organization review if similar problems have occurred in the past, or could potentially occur? Examples?
– Does the organization update the risks and opportunities determined during planning, when necessary? Examples?
Until next time…
Helping Business Professionals Reduce Risk and Remove Waste!