Issue 63 – Clause 9.3: Management Review
ISO 9001:2015…
Clause 9.3: Management Review
What’s the intent of Clause 9.3?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 62) we discussed the topic of “performing a self-check”, and now here in Clause 9.3 we address the area of “management review” of your QMS. The intent of this Clause is to have top management review the performance and effectiveness the QMS and take actions as necessary.
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, gap audits and internal audits, where the requirements of the Standard have to be interpreted and applied to each unique situation. A 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 use an outside resource to assist with 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 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 – 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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ISO 9001:2015 Internal Audit Outsourcing (we can do it for you OR with 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 the Internal Audit requirements in the ISO Standards. We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with your Team of internal auditors, we complete the entire audit together. This latter approach allows your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.
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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.
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Q: How do you perform an audit for Clause 9.3 of ISO 9001:2015?
A: For Clause 9.3, an Audit Checklist should cover these areas:
– Has top management ensured that its QMS is reviewed at planned intervals? How?
– Has top management ensured that its QMS continues to be suitable, adequate, and effective? How?
– Has top management ensured that its QMS is aligned with the strategic direction of the organization? How?
– Has top management taken into consideration the status of actions from previous management reviews?
– Has top management taken into consideration changes in external and internal issues that are relevant to the quality management system?
– 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 process performance and conformity of products and services?
– Has top management reviewed nonconformities and corrective actions?
– Has top management reviewed monitoring and measurement results?
– Has top management reviewed audit results?
– 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?
– Has top management reviewed opportunities for improvement?
– Has outputs from management reviews included decisions and actions related to opportunities for improvement?
– Has outputs from management reviews included decisions and actions related to any need for changes to the quality management system?
– Has outputs from management reviews included decisions and actions related to resource needs?
(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!