ISO 9001:2015 – Newsletter – Issue 6



Issue 6 – Element 6.0: Planning


ISO 9001:2015…

Element 6.0 – Planning


What’s new in Element 6.0?… The term “risk” is new and as I mentioned in my last Newsletter (ISO 9001:2015 Newsletter Issue 5), I gave a presentation to the ASQ Toronto Section on Oct 14th where I reviewed the main changes within ISO 9001:2015.  There was record attendance (approx. 140 people) and they had lots of questions, mostly about the topic of “risk”.  There seems to be a lot of confusion on how to handle the new “risk” requirements in the Standard.  Click HERE to download a copy of this presentation.

The new Clause numbering…

Section 4 – Context of the organization
Section 5 – Leadership
Section 6 – Planning
Section 7 – Support
Section 8 – Operation
Section 9 – Performance evaluation
Section 10 – Improvement


Element 6.0 Planning consists of three (3) Clauses as listed below:

6.1  Actions to address risks and opportunities

6.2  Quality objectives and planning to achieve them

6.3  Planning of changes


Clause 6.1  Actions to address risks and opportunities:  This Clause contains two sub-clauses, namely 6.1.1 and 6.1.2 (with neither of these sub-clauses having titles). We previously discussed Clause 6.1 back in an earlier Newsletter (ISO 9001:2015 Newsletter Issue 3), when we covered the topics of Business/Strategic Planning and SWOT, where both of these approaches should generate actions to address risks and opportunities, which is what is needed to comply with this Clause.

Sub-Clause 6.1.1 asks you to refer back to the issues in Clause 4.1 (Understanding the Organization and its Context) and the requirements in Clause 4.2 (Understanding the Needs and Expectations of Interested Parties) as part of your “planning” process, and then continues on to explain why you need to address risks and opportunities, in sub-clause parts [a] through [d].

Sub-Clause 6.1.2 carries on and asks you to [a] “plan” actions for risks/opportunities, and [b] “plan” how you will weave these actions into your QMS (and then check whether these actions worked).  They finish by reminding you that it is completely your decision on how big or how small these actions will be.

They’ve also added a couple of “NOTES” at the end which attempt to clarify the words in this Clause.


Clause 6.2  Quality objectives and planning to achieve them:  This Clause contains two sub-clauses, namely 6.2.1 and 6.2.2 (with neither of these sub-clauses having titles).  Sub-Clause 6.2.1 starts off being very similar to the requirements in the 2008 version but adds that these quality objectives should also be established for “processes”, which is something new.

Sub-Clause 6.2.1 parts [a] through [e] outline requirements that are not really different from 2008, however [f] and [g] asks that you communicate the quality objectives and that you keep them updated.  Finally they make sure that there is no confusion by telling you to maintain them as “documented information”.  These requirements add some teeth to what I’ve always said is a critical Clause within the ISO 9001 Standard because it drives your quality performance.

Sub-Clause 6.2.2 parts [a] through [e] definitely add new substance to the topic of Quality Objectives by asking “Who”, “What”, “When” and “How”.  This level of detailed requirements will ensure that you are clearly stating how you handle quality objectives within your organization.  This new ISO 9001:2015 Standard is attempting to achieve more “business alignment”, and all of the Clauses within Element 6.0 are a good example of that.


Clause 6.3  Planning of changes:  This Clause has essentially the same requirements as the 2008 version and therefore should have limited impact on an existing QMS that is currently compliant with ISO 9001.


Make 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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Q: How should Quality Objectives be developed? Are they the same as Business Objectives?

A: Let me start with the second part of the question.  Yes, Quality Objectives can be identical to the Business Objectives, or they can be a sub-set of them.  Business Objectives are generated from the key words found within an organization’s Mission Statement.  If you state that you want to be the market leader in your industry then you need to set a measurable objective (and an action plan) that will get you there.  This is the same approach that you should use with your QMS by ensuring that your Quality Objectives flow directly from the key words within your Quality Policy statement.  So if your Quality Policy says something like “…we make sure Customers are always satisfied by being on-time every time…” then you would need two quality objectives, one for the level of Customer Satisfaction you want to achieve, and another objective for the on-time delivery performance that you are striving towards.


Until next time…

Tim Renaud

Helping Business Professionals Reduce Risk and Remove Waste!