ISO 9001:2015 – Newsletter – Issue 33



Issue 33 – Clause 9.1:  Monitoring, Measurement, Analysis and Evaluation


ISO 9001:2015…

Clause 9.1:  Monitoring, measurement, analysis and evaluation


What’s new in Clause 9.1?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 32) we discussed the topic of “controlling surprises”, and now here in Clause 9.1 we move into Element 9.0 (Performance evaluation) and address the first Clause within it, dealing with “monitoring, measurement, analysis and evaluation”.
Note A:  This Clause DOES include requirements for “documented information”.
Note B:  In case 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 for proposal from our Newsletter readers.  The second most popular request is our on-site Document Development Training Workshop (…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 9.1  Monitoring, measurement, analysis and evaluation consists of three (3) Sub-Clauses as listed below:

9.1.1  General

9.1.2  Customer satisfaction

9.1.3  Analysis and evaluation


Sub-Clause 9.1.1  General – I’ll start this off by saying that for many organizations, Sub-Clause 9.1.1 covers essentially the same territory as the old Clause with the same title found back in 2008.  This sub-clause is asking organizations to outline what the plan is for monitoring, measuring, analysing and evaluating its processes, its products and its services.  Essentially these are not new requirements however they have added the word “when”, as in when the monitoring and measuring will be performed, and when will the results from monitoring and measurement be analysed and evaluated.  You may have already addressed this within your current QMS… if not, then you will need to decide how to implement these “when” requirements.


Sub-Clause 9.1.2  Customer satisfaction – Some of you may already know that I have always viewed Customer Satisfaction as THE most important clause in ISO 9001.  I consider ISO 9001 to be a Customer Satisfaction Standard.  It contains all of the ingredients for how to meet your Customer requirements.  Unfortunately a number of organizations don’t spend enough time leveraging this sub-clause to get maximum impact for their business.  It is only two sentences long but carries a lot of weight as a critical indicator of how effective your entire QMS is.  In this new version, they have expanded the scope of this topic beyond simply satisfying “Customer requirements”, to now being “the degree to which Customer needs and expectations have been fulfilled”.  In other words, the Customer may issue you a Purchase Order (PO), which specifies their requirements, but will a PO tell you what their “needs” and “expectations” are, and whether you’ve satisfied those needs and expectations when you fill their order?


Sub-Clause 9.1.3  Analysis and evaluation – What is new here in this sub-clause, are items (a), (d), (e) and (f).  In 9.1.3 (a) they have once again added the “…and services” phrase with respect to analysing/evaluating nonconformities.  Sub-clause 9.1.3 (d) now wants organizations to analyse their data to evaluate whether ALL of their planning activities have been effective.  Within sub-clause 9.1.3 (e), organizations are being asked to assess how effective their actions have been in addressing risks and opportunities within the business.  Finally in 9.1.3 (f) what’s new here is the term “external providers” versus “suppliers” in the old 2008 version.  This expands the reach of this requirement to other entities such as a Corporate office or a sister facility.


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 9.1 of ISO 9001:2015?

A:  For Clause 9.1, a Gap Audit checklist should cover these areas:

–  Has the organization defined “when” monitoring and measurement will be performed?
–  Has the organization defined “when” the results from monitoring and measurement will be analysed? Will be evaluated?
–  Has the organization retained appropriate documented information regarding these activities?
–  Does the organization monitor their Customer’s perception of the degree to which their needs and expectations have been fulfilled? How?
–  Does the organization analyse service activities/results? How? Is this analysis used to evaluate service conformity?
–  Does the organization analyse planning activities/results? How? Is this analysis used to evaluate the effectiveness of their planning?
–  Does the organization analyse the actions taken to address risks and opportunities? How? Is this analysis used to evaluate the effectiveness of these actions?
–  Does the organization analyse the performance of ALL external providers? How?

(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!