ISO 9001:2015 – Newsletter – Issue 61



Issue 61 – Clause 9.1:  Monitoring, Measurement, Analysis and Evaluation


ISO 9001:2015…

Clause 9.1:  Monitoring, Measurement, Analysis and Evaluation


What’s the intent of Clause 9.1?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 60) we discussed the topic of “controlling surprises”, and now here in Clause 9.1 we address the area of “monitoring, measurement, analysis and evaluation”.  The intent of this Clause is captured in the phrase “what gets measured gets managed” and that’s the focus of all the requirements found within this section.

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, 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 9.1: 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 – Let me begin 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 the 2008 version.  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 – I have always viewed Customer Satisfaction as THE MOST IMPORTANT clause in this Standard.  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 the wording 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?  Will a PO tell you 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 the word “suppliers” which was the term used 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…


To view all of our past Newsletters or to sign up to receive them… click here



Need Help?

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.



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.



Q:  How do you perform an audit for Clause 9.1 of ISO 9001:2015?

A:  For Clause 9.1, an Audit Checklist should cover these areas:

–  Has the organization defined “what” needs to be monitored and measured?
–  Has the organization defined the methods for monitoring, measurement, analysis and evaluation to ensure valid results?
–  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 evaluated the performance and effectiveness of the QMS?
–  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 is this information obtained, monitored and reviewed?
–  Does the organization analyse production results? How? Is this analysis used to evaluate product conformity?
–  Does the organization analyse service activities/results? How? Is this analysis used to evaluate service conformity?
–  Does the organization analyse and evaluate the degree of Customer satisfaction? How?
–  Does the organization analyse and evaluate the performance and effectiveness of the QMS? How?
–  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?
–  Does the organization analyse and evaluate the need for improvements to the QMS? 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!