Issue 20 – Clause 6.3: Planning of changes
ISO 9001:2015…
Clause 6.3: Planning of changes
What’s new in Clause 6.3?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 19) we discussed the topic of “quality objectives”, and now here in Clause 6.3 we address the area of “planning QMS changes”, which by the way 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 a requirement 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 numerous gap audits, where the requirements of the Standard have to be interpreted and applied to each unique situation. Combining a Gap Audit with ISO 9001 Essentials Training, has become our most popular request from our Newsletter readers (…more details on this, as well as other training, can be found below).
RISK & RISK-BASED THINKING:
I continue to receive emails about the new term “risk-based thinking” and how an organization should address it. In a previous Newsletter (ISO 9001:2015 Newsletter Issue 18) I covered this topic, however based on the continued confusion in this area I thought I’d point out what Annex A.4 has to say about “risk-based thinking”… the following words were taken directly from the ISO 9001:2015 Standard (bolded words are mine):
Although 6.1 specifies that the organization shall plan actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process. Organizations can decide whether or not to develop a more extensive risk management methodology than is required by this International Standard, e.g. through the application of other guidance or standards.
Not all the processes of a quality management system represent the same level of risk in terms of the organization’s ability to meet its objectives, and the effects of uncertainty are not the same for all organizations. Under the requirements of 6.1, the organization is responsible for its application of risk-based thinking and the actions it takes to address risk, including whether or not to retain documented information as evidence of its determination of risks.
I hope the above statement will help to reduce the concern about what will be needed to comply with this new vague term called “risk-based thinking”…
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 being very similar to the requirements in the old 2008 version, 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. One thing that was left out in this new version (that was included in 2008), was the requirement that any changes made to the QMS should support the achieving of the Quality Objectives.
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 a repeat from 2008 regarding maintaining the integrity of the QMS. 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.
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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Need Training?
ISO 9001:2015 Essentials + Gap Audit
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.
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Internal Process Auditing for ISO 9001:2015
The two (2) day Internal Process Auditing for ISO 9001:2015 Session (also covers requirements in ISO 19011) 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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Q: How do you perform a gap audit for Clause 6.3 of ISO 9001:2015?
A: For Clause 6.3, a Gap Audit checklist should cover these areas:
– Has the organization made any changes to its QMS in the past year?
– Was a plan prepared to implement the change?
– Did the plan cover the purpose of the change and the potential consequences?
– 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?
– Does a plan exist 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…
Tim Renaud
Helping Business Professionals Reduce Risk and Remove Waste!