ISO 9001:2015 – Newsletter – Issue 9



Issue 9 – Element 9.0:  Performance Evaluation


ISO 9001:2015…

Element 9.0 – Performance Evaluation


What’s new in Element 9.0?… We covered the “operation” of the organization in my last Newsletter (ISO 9001:2015 Newsletter Issue 8), and now Element 9.0 (Performance Evaluation) focuses on “measuring” how your Quality Management System (QMS) is performing.  For the most part Element 9.0 does not introduce any significant changes over the 2008 version.  Some of the minor changes include a more prescriptive “General” lead-off section covered in Sub-Clause 9.1.1, which is a welcome change from the previous 2008 version which was essentially redundant.  Customer Satisfaction and Internal Audit, which are two of the most critical sections of ISO 9001 remain pretty much unchanged.  More specific “analysis”, along with an expanded scope for these analyses are changes that have found their way into this Element.  Finally, “Management Review” has had some minor modification, the most important being the addition of this phrase “…and alignment with the strategic direction of the organization“.  This represents one of the main changes that I’ve seen in this new edition of ISO 9001.  They have attempted to connect the QMS with the “Business”, and this is just one example of tying these two together.



The new Clause numbering… 

Section 4 – Context of the organization
Section 5 – Leadership
Section 6 – Planning
Section 7 – Support
Section 8 – Operation
Section 9 – Performance evaluation
Section 10 – Improvement


Element 9.0 Performance evaluation consists of three (3) Clauses as listed below:

9.1  Monitoring, measurement, analysis and evaluation

9.2  Internal Audit

9.3  Management Review


Clause 9.1 Monitoring, measurement, analysis and evaluation:  This Clause contains three (3) sub-clauses,  Sub-Clause 9.1.1 (General), Sub-Clause 9.1.2 (Customer satisfaction) and Sub-Clause 9.1.3 (Analysis and evaluation).  As I mentioned above, the first sub-clause (9.1.1) is a more prescriptive version from 2008, and asks “when” monitoring and measurement will take place and “when” the data will be analysed.  It is also asks for “documented information” as evidence.  Sub-Clause 9.1.2 (Customer Satisfaction) contains much of the same from 2008 however it uses the term “Customer needs and expectations” rather than “Customer requirements” which makes it broader and more subjective as a criteria for measuring Customer satisfaction levels.  Also, they’ve included the phrase “…shall determine the methods for obtaining, monitoring and reviewing this information“, with the new word “monitoring” having been added in from the previous 2008 version.  Sub-Clause 9.1.3 (Analysis and evaluation) repeats many of the “shall” requirements from the previous 2008 edition, and adds two more areas of analysis (9.1.3 d and e) regarding the effectiveness of “planning activities” as well as determining how effective were your “actions taken to address risks and opportunities”.


Clause 9.2  Internal audit:  This Clause contains two (2) sub-clauses, Sub-Clause 9.2.1 and Sub-Clause 9.2.2, neither of which have titles on them.  In my introductory paragraph above I noted that there was really nothing new added to this Clause with the exception that the “internal audit process” will now need to cover a much broader range of QMS requirements than what auditors saw with the 2008 version.  Although there is still a “Note” referencing ISO 19011 as a “guidance” document, let me take this opportunity to re-iterate that it still your choice how you train, and how you ensure competency of your Internal Auditors.  The requirements of ISO 19011 are not a part of ISO 9001:2015 unless you make it so by including ISO 19011 within your QMS.


Clause 9.3  Management review:  This Clause contains three (3) sub-clauses, Sub-Clause 9.3.1 (General), Sub-Clause 9.3.2 (Management review inputs) and Sub-Clause 9.3.3 (Management review outputs).  Sub-Clause 9.3.1 (General) includes a very direct connection to your “Business” by asking you to make sure that your QMS is aligned with the “strategic direction” of your organization.  This is a new requirement but one that makes good sense to implement properly.  The other change here is the omission of the term “Quality Policy” from being part of the management review process.  Sub-Clause 9.3.2 (Management review inputs), item e) refers back to Clause 6.1 by stating “…management review shall be planned and carried out taking into consideration …the effectiveness of actions taken to address risks and opportunities (see 6.1)“.  The rest of this sub-clause is much the same as found before in earlier versions.  Finally, Sub-Clause 9.3.3 (Management review outputs) eliminates the word “any” from this sentence “The outputs of the management review shall include any decisions and actions related to…“.  This removes the option of claiming that if no decisions were made during management review then the old sub-clause called “Review Output” did not apply.  Also, items a), b) and c) of Sub-Clause 9.3.3 are similar yet less demanding then their predecessors back in 2008.



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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Q:  I’m the QMS Rep and I want to get started on making the transition to the new ISO 9001:2015, how should I begin?

A:  I would suggest you schedule one week to get this initiative launched.  You should attempt to involve all of your internal auditors (as well as anyone else who is interested in helping make this transition).  Obtain a copy of the new ISO 9001:2015 Standard and project it onto a big screen for everyone to see.  Starting with Element 4.0 (Context of the organization), review the requirements and highlight the obvious additions and changes.  I say “obvious” because otherwise your session will disintegrate into arguing about the minutia.  Once an Element is complete, perform a gap audit to assess and document what needs to be done to comply.  Try and get Elements 4, 5, 6, 7, 9, 10 done in three days (half day each) and reserve a whole day for Element 8.0 (Operation).  On the fifth day, finalize your gap audit report and issue it to all attendees, as well as to top management, so they get a sense of how much work will be involved in making this transition.  I’ve had good success so far helping companies do exactly what I’ve described above.  I simply combined my “Essentials” training with my “Gap Audit” service.  The added advantage is that all attendees received a training certificate covering their education on the new ISO 9001:2015 Standard.


Until next time…

Tim Renaud

Helping Business Professionals Reduce Risk and Remove Waste!