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 thinking.  This 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.