ISO 9001:2015 – Newsletter – Issue 43

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 sentence sets the tone in this sub-clause: “Top management shall demonstrate leadership and commitment with respect to the quality management system by…”, and they then proceed to give you ten (10) ways to demonstrate it, which is double the number from the 2008 version.

Sub-Clause 5.1.1 a) asks top management to take accountability for the effectiveness of the QMS… the word “accountability” was not found anywhere in the 2008 version.  How does one take accountability for the effectiveness of the QMS?  One way is to react quickly to fix the QMS if it breaks.  Another way is to be proactive and regularly monitor the QMS, looking for any signs that it might break.   Performance appraisals/reviews that include a job responsibility for ensuring an effective QMS is maintained, would also do it.

Sub-Clause 5.1.1 b) contains a requirement that top management ensure that the quality policy and the quality objectives are defined AND that they are compatible with the context (see Clause 4.1) AND compatible with strategic direction of the organization.  One way to demonstrate compliance here would be to show that the same people who wrote the quality policy and objectives, were also the same people who set the direction for the company each year… and of course these people need to be the “top management” of the organization.

Sub-Clause 5.1.1 c) asks top management to integrate the QMS into its business processes.  This implies that the QMS is not a separate set of rules that run parallel to the business activities but rather just another business criteria that must be met, much like “being profitable”.  You get a hint of this integration when a “quality” KPI (Key Performance Indicator) is found on a performance scorecard for top management, right alongside EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization).

Sub-Clause 5.1.1 d) asks top management to promote the use of the process approach AND 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, 5.0, 6.0. 7.0, 8.0, 9.0 and 10.0, of ISO 9001:2015, is the term “risk-based thinking” found.  Interesting isn’t it?  Considering all the excitement 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).  One other detail I should also mention is that there is no requirement to provide documented information on how you promote risk-based thinking, that’s right, none… verbal only responses from your top management will handle this new requirement.  I will have more to say on the “risk” topic when I get to Clause 6.1, so stay tuned because I will share an approach organizations can use to address “risk” and “risk-based thinking”.

Sub-Clause 5.1.1 e) wants you to make sure that resources needed for the QMS, are indeed provided.  This can be addressed as part of the annual business planning activities where targets/goals are set for the next fiscal year and budgets are approved.  As long as the budgeting process includes requests for quality related resources then that will show compliance.  Of course this is a two edged sword because quality problems/complaints due to lack of resources would indicate this requirement is not being met.

Sub-Clause 5.1.1 f) ask top management to tell the employees in the organization that it’s important to the business that they adhere to what the QMS asks them to do.  One way to demonstrate their commitment here is not to break the QMS rules themselves, which means they have to know what the QMS asks top management to do.

Sub-Clause 5.1.1 g) wants top management to make sure that the QMS achieves its goals (intended results) and if it isn’t, then take accountability by looking in the mirror and taking actions to fix it, which we discussed up above in the first item (5.1.1a).

Sub-Clause 5.1.1 h) asks top management to engage, to direct and to support individuals that can contribute to ensuring an effective QMS is in place.  This implies they will encourage a team-approach in managing quality and that they themselves are part of this team.

Sub-Clause 5.1.1 i) simply says “promote improvement”… this should be one of the primary goals of top management, which they can demonstrate through the setting of new targets and objectives each year.

Finally, in Sub-Clause 5.1.1 j) top management is asked to demonstrate their “leadership” to the QMS by showing they also show “leadership” by supporting other relevant management roles in other areas of the business (such as Health & Safety and the Environment).

Sub-Clause 5.1.2 Customer focus – This requirement leads off by asking top management to demonstrate leadership and commitment in the area of “Customer focus” by providing three (3) ways to do it.

Sub-Clause 5.1.2 a) wants top management to make sure that Customer requirements are first determined, and then once they are, make sure they are understood, and finally that they are met, and met consistently.  The same thing needs to be done for any statutory requirements and any regulatory requirements, that are applicable to the QUALITY of your products or the QUALITY of your services.

Sub-Clause 5.1.2 b) asks that top management first determine, and then address, any risks or any opportunities that could affect the quality of its products, or the quality of its services.  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.  As I said above, I will have more to say on the “risk” topic when I get to Clause 6.1 in a later Newsletter.

Sub-Clause 5.1.2 c) finishes off by asking top management to maintain a focus on enhancing Customer satisfaction.  That implies not just satisfying Customers but delighting them… a difficult challenge because it means constantly raising their expectations… however if you don’t make the attempt, you’ll eventually get run over by your competition.

Be sure to watch for our next Newsletter issue where we will cover another section of ISO 9001:2015…