ISO 9001:2015 – Newsletter – Issue 43



Issue 43 – Clause 5.1:  Leadership and commitment


ISO 9001:2015…

Clause 5.1:  Leadership and commitment


What’s the intent of Clause 5.1?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 42) we discussed the topic of “your quality management system itself”, and now here we move into the next Element called “Leadership”, and here in the first Clause (5.1) we address “leadership and commitment”.  Clause 5.1 represents a doubling of the “shall” requirements from the 2008 version, and it now uses the term “Leadership” versus “Management Responsibility”.  This change sends a strong signal that top management shouldn’t have to be dragged along but rather they should be “leading” the charge towards “quality”.  Clause 5.1 uses words such as:

“taking accountability for the effectiveness of the QMS”…

“compatibility with strategic direction”…

“integration of QMS into the business”…

“promoting risk-based thinking”…

“ensuring the QMS achieves its intended results”…

“ability to enhance customer satisfaction is determined and addressed”…

These phrases have more bite to them than what we saw in the 2008 version, and will require a different (and longer) conversation with top management in order to address them.

Note A:  This Clause DOES include requirements for “documented information”.
Note B:  In the event you were curious, 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 training workshops and gap audits, where the requirements of the Standard have to be interpreted and applied to each unique situation.  Combining an on-site Gap Audit with ISO 9001:2015 Essentials Training, has become our most popular request from our Newsletter readers, because the first step in making the transition is to understand how big of a gap needs to be closed.  Another popular training request is our on-site Internal Process Auditor Training for ISO 9001:2015 since you will need to do a complete round of internal audits to the new Standard prior to your external upgrade audit.  On that note, some organizations are opting to outsource their internal audits in order to meet deadlines (…more details on this service, as well as the training sessions we offer, can be found below).


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…


PS: Don’t forget to look at the Q&A section below for some final thoughts…


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ISO 9001:2015 Internal Audit Outsourcing (we do it for you)

For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy Internal Audit requirements within the ISO Standards.


Documentation Development Training Workshop for ISO 9001:2015

This Documentation Development Training Workshop for ISO 9001:2015 Session is intended to be a very interactive, hands-on session (hence the name Workshop) where your QMS documentation will be created/revised, with guidance from an experienced facilitator.  This type of session can help launch your transition efforts by getting a lot accomplished within a compressed time-frame.  If your organization has already begun the re-write then this session can be used to validate what you’ve accomplished so far, or if you haven’t yet begun, it can be the catalyst to get things started (…which is usually the hardest part).  Deciding how to move from your current QMS structure into a new one can be a daunting task and this session can help you navigate through it.  A copy of a sample Quality Manual (re-iterating the “shall” requirements found within the ISO 9001:2015 Standard) will be provided to each participant.  As always, our focus will be on how to develop a simplified and streamlined quality management system, that helps to drive improvement in your business.


Internal Process Auditor Training for ISO 9001:2015

The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session 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.


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 an audit for Clause 5.1 of ISO 9001:2015?

A:  For Clause 5.1, an 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 the use of a process approach in the organization? How?
– Has Top Management promoted risk-based thinking in the organization? How?
– How has Top Management made sure that resources are made available for the QMS?
– 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 promoted improvement within the organization?
– How has Top Management supported other relevant management roles to show their leadership in their areas of responsibility?
– How has Top Management ensured that Customer requirements have been determined? have been understood? have been consistently met?
– How has Top Management ensured that applicable statutory and regulatory requirements have been determined? have been understood? have been consistently met?
– 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 the enhancement of Customer satisfaction, been addressed? How?
– How has Top Management maintained a focus on enhancing Customer satisfaction?

(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!