ISO 9001:2015 – Newsletter – Issue 15



Issue 15 – Clause 5.1:  Leadership and Commitment


ISO 9001:2015…

Clause 5.1: Leadership and Commitment


What’s new in Clause 5.1?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 14) we discussed the topic of “QMS and its Processes” which was outlined in the previous Clause, and now here in Clause 5.1 we address the new term “Leadership”.
NOTE: This Clause does not include a requirement for “documented information”.


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 5.1 Leadership and Commitment consists of two (2) Sub-Clauses as listed below:

5.1.1  General

5.1.2  Customer Focus


Sub-Clause 5.1.1 General –  The first five words set the tone in this sub-clause: “Top management shall demonstrate leadership…”, and then they proceed to give you ten (10) ways to demonstrate it, which is double the number from the 2008 version.  In the 2015 edition of this Standard, this area adds some new requirements, the first being Sub-Clause 5.1.1 a) which asks top management to take accountability for the effectiveness of the QMS… this word was not found anywhere in the 2008 version.  The second being Sub-Clause 5.1.1 b) where there is a requirement that top management ensure that the quality policy and the quality objectives are compatible with the context and strategic direction of the organization.  The third is Sub-Clause 5.1.1 c) which asks top management to integrate the QMS into its business processes.  These last two additions clearly asks that top management view the QMS as an integral part of how the business is run.

The fourth additional requirement (from 2008) is Sub-Clause 5.1.1 d) which asks top management to promote the use of risk-based thinkingThis is the one and only “shall” requirement within the entire Standard that mentions risk-based thinking.  Nowhere else within Elements 4.0 through to Element 10.0, of ISO 9001:2015, is the term “risk-based thinking” found.  Interesting isn’t it?  Considering all the hoopla that has been raised on this topic, in various webinars and online forums, one would have thought there would have been multiple “shalls” requiring risk-based thinking (but no, just once, in sub-clause 5.1.1 d).  I will have more to say on the “risk” topic when I get to Clause 6.1, so stay tuned when I will share more information on one approach organizations can use to address risk, and risk-based thinking.

The fifth and sixth new requirements are found in Sub-Clauses 5.1.1 f) & g) which ask top management to communicate the importance of effective quality management and to ensure that the QMS achieves its intended results.   It would be a good exercise for every organization seeking to transition to this new ISO 9001:2015 Standard, to first decide who is considered “top management” and then to ask them to express what they see as the “intended results” for their QMS.  Continuing on, Sub-Clause 5.1.1 h) is one place where they have attempted to deal with eliminating the previous role of Management Representative, by spreading this responsibility to others.  Finally, in Sub-Clause 5.1.1 j) they ask top management to support other relevant management roles in providing “leadership”, in other areas of the business.


Sub-Clause 5.1.2 Customer Focus –  This requirement leads off by asking top management to demonstrate leadership in this area of “Customer focus” by providing us with three (3) ways to do it, two of which were found in the previous 2008 version.  Sub-Clause 5.1.2 b) adds a new requirement asking that top management ensure that risks and opportunities that can impact Customer satisfaction with the organization’s products and services, are properly addressed.  Although the Standard doesn’t reference Clause 6.1 (Actions to address risks and opportunities), it should have, since that is where top management needs to point, to demonstrate that they’ve addressed this requirement.



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.



Q:  How do you perform a gap audit for Clause 5.1 of ISO 9001:2015?

A:  For Clause 5.1, a Gap Audit checklist should cover these areas:

–  Who is considered to be “top management” in this organization? Is that documented anywhere?
–  Has Top Management taken accountability for the effectiveness of the QMS?  How?
–  Has Top Management ensured that the quality policy is aligned with their strategic direction?  How was that done?
–  Has Top Management ensured that the quality objectives are aligned with their strategic direction?  How was that done?
–  How has Top Management integrated the QMS into its business processes?
–  Has Top Management promoted risk-based thinking in the organization? How?
–  Has Top Management communicated the importance of managing quality to the organization? How?
–  What are the intended results of the QMS? How has top management ensured that the QMS has achieved those intended results?
–  Has Top Management engaged, directed and supported those persons who contribute to an effectively functioning QMS? How?
–  How has Top Management supported other relevant management roles to show their leadership in their areas of responsibility?
–  Has Top Management ensured that the risks and opportunities related to product and service conformance, been addressed? How?
–  Has Top Management ensured that the risks and opportunities affecting Customer satisfaction levels, been addressed? How?

(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!