ISO 9001:2015 – Newsletter – Issue 35



Issue 35 – Clause 9.3:  Management review


ISO 9001:2015…

Clause 9.3:  Management review


What’s new in Clause 9.3?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 34) we discussed the topic of “internal audit”, and now here in Clause 9.3 we address “review of your QMS by Top Management”.
Note A:  This Clause DOES include requirements for “documented information”.
Note B:  As some of you already know, 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 for proposal from our Newsletter readers.  Another popular training request is our on-site Internal Process Auditor Training for ISO 9001:2015 (…more details on these training sessions, as well as other training that 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 9.3  Management review consists of three (3) Sub-Clauses as listed below:

9.3.1  General

9.3.2  Management Review Inputs

9.3.3  Management Review Outputs


Sub-Clause 9.3.1  General – So let me start by saying that some new words have been added to this sub-clause as follows: “top management shall review the organization’s QMS…to ensure its… alignment with the strategic direction of the organization”.   This is another example of where this new Standard is attempting to connect the quality management  system with how the business operates.  This requirement is asking top management to make sure that its QMS is heading in the same direction as the business is, and if it’s not, then implement actions to correct this situation.  In addition, some requirements have been removed, such as “the need for changes to … the quality policy and quality objectives”, however I’d recommend you continue to review your Quality Policy and your Quality Objectives, since both topics are critical for an effective QMS.


Sub-Clause 9.3.2  Management review inputs – The list of agenda topics have been expanded from the previous 2008 version.  Here are the new items that have been added: Sub-clause 9.3.2 (c-1) – feedback from relevant interested parties (who the interested parties are should have been defined way back in Clause 4.2); Sub-clause 9.3.2 (c-2) – the extent to which quality objectives have been met (something that just makes common sense); Sub-clause 9.3.2 (c-3) – conformity of services (so not just products, with your services being defined in Clause 4.3); Sub-clause 9.3.2 (c-7) – the performance of external providers (includes any goods or services provided by Suppliers, Vendors, Corporate Office, Sister Facilities, etc); Sub-clause 9.3.2 (d) – the adequacy of resources (time, people, money, equipment, etc); and Sub-clause 9.3.2 (e) – the effectiveness of actions taken to address risks and opportunities (go back and re-read ISO 9001:2015 Newsletter Issue 18 for help on how to handle this requirement).


Sub-Clause 9.3.3  Management review outputs – Although they haven’t added anything new into this sub-clause, they have removed the old requirement which stated “actions related to… improvement of product related to customer requirements”.  In the past, this was always the most difficult of the output actions to demonstrate however it did provide some focus for where improvements should be made.


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 Help?

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, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy Internal Audit requirements in 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 a gap audit for Clause 9.3 of ISO 9001:2015?

A:  For Clause 9.3, a Gap Audit checklist should cover these areas:

–  Has top management ensured that its QMS is aligned with the strategic direction of the organization?  How?
–  Has top management included feedback from relevant interested parties during its management review activities?  Examples?
–  Has top management reviewed the extent to which quality objectives have been met during its management review activities?
–  Has top management reviewed the performance of its external providers during its management review activities? How?
–  Has top management reviewed the adequacy of resources during its management review activities?
–  Has top management reviewed the effectiveness of actions taken to address risks and opportunities during its management review activities?


Until next time…

Tim Renaud

Helping Business Professionals Reduce Risk and Remove Waste!