Issue 48 – Clause 6.3: Planning of changes
Clause 6.3: Planning of changes
What’s the intent of Clause 6.3?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 47) we discussed the topic of “Quality Objectives”, and now here in this Clause we address “Changes to your QMS”. Since “change” is inevitable, the intent of Clause 6.3 is to have a process in place to manage any changes that you make to the QMS that you built way back in Clause 4.4 (Quality management system and its processes). One great example of applying the requirements within this Clause is what you will be doing to your current QMS when you transition to this new ISO 9001:2015 Standard!
Note A: This Clause DOES NOT 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, 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 6.3 Planning of changes consists of zero (0) Sub-Clauses…
The lead off sentence starts off by essentially asking that if the organization intends to make a change to its Quality Management System (QMS), then that event should be planned for in advance. This applies to any change, big or small, with the idea being that your Customers won’t have to experience upheaval with their Orders while you roll out changes to your QMS.
Parts [a] through [d] within this sub-clause outline requirements that provide much more substance then what was found in the old version (2008). Item [a] asks that if a change to the QMS is planned then the organization must consider what the purpose is of making this change, as well as the potential consequences resulting from it. Item [b] is about maintaining the integrity of the QMS while the change or changes are taking place. Item [c] asks that the organization consider the resources required to implement the change, and Item [d] deals with the allocation (or re-allocation) of responsibilities and authorities as a result of the change.
As I said above, a good example of when this Clause applies would be for making the transition to this new ISO 9001:2015 Standard, when your organization will upgrade its QMS to comply with these new requirements!
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, 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.
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 an audit for Clause 6.3 of ISO 9001:2015?
A: For Clause 6.3, an Audit Checklist should cover these areas:
– Has the organization made any changes to its QMS in the past year?
– If Yes, was a plan put in place to implement the change?
– Did the plan cover the purpose of the change and the potential consequences? Explain?
– Did the plan ensure that the integrity of the QMS was maintained? How?
– Did the plan address what resources would be required and their availability?
– Did the plan reflect the allocation (or re-allocation) of responsibilities and authorities?
– What plan was followed for making the transition to the new ISO 9001:2015 Standard?
(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!