ISO 9001:2015 – Newsletter – Issue 30



Issue 30 – Clause 8.5:  Production and Service Provision


ISO 9001:2015…

Clause 8.5:  Production and Service Provision


What’s new in Clause 8.5?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 29) we discussed the topic of “externally provided processes, products and services”, and now here in Clause 8.5 we address the area dealing with “providing products and services”.  At this point within Element 8.0 (Operation), you’ve covered all of the steps necessary to begin producing products and providing services to your Customers.
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 gap audits (as well as training seminars), 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 Essentials Training, has become our most popular request for proposal from our Newsletter readers (…more details on this, 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 8.5  Production and service provision consists of six (6) Sub-Clauses as listed below:

8.5.1  Control of production and service provision

8.5.2  Identification and traceability

8.5.3  Property belonging to customers or external providers

8.5.4  Preservation

8.5.5  Post-delivery activities

8.5.6  Control of changes


Sub-Clause 8.5.1  Control of production and service provision – I’ll start this off by saying that for many organizations, Sub-Clause 8.5.1 covers essentially the same territory as the old Clause with the same title found  back in 2008.  This sub-clause is asking organizations to implement a number of conditions in order to “control” the process used to produce a product or to supply a service.

Sub-clause 8.5.1 a) is asking you to provide “documented” (this is new) information that shows exactly what product is being produced or what service is being supplied, including the results expected (also new).  Sub-clause 8.5.1 b) and c) are dealing with “monitoring and measurement” controls, whereas 8.5.1 d) retained the previously used term “equipment” but expanded it to include “infrastructure and environment”.  Sub-clause 8.5.1 e) is new, in that it states “people” are an important part of controlling a process.  Sub-clause 8.5.1 f) is the old “special processes Clause from the 2008 version, that most organizations took an “NA” on.  Sub-clause 8.5.1 g) is brand new and deals with “mistake proofing” as a technique for process control, and finally 8.5.1 h) is an exact repeat requirement from 2008.


Sub-Clause 8.5.2  Identification and traceability – This sub-clause adds no new requirements for identifying and tracing products, with the exception of the “and services” statement.  As I’ve said previously, look at those “services” you listed in your Scope statement and then decide how best to apply the requirements within this Clause.


Sub-Clause 8.5.3  Property belonging to Customers or external providers – This sub-clause has expanded its reach by now including property belonging to Vendors (external providers).   In addition, you’ll need to pay attention also to the “and services” impact to see what might now covered by this sub-clause.  Keep in mind that property can also be intangible such as “information” or “data”.


Sub-Clause 8.5.4  Preservation – This sub-clause adds no new requirements for preservation of products, with the exception of the “and service” statement.  As I’ve said previously, look at those “services” you listed in your Scope statement and then decide how best to apply the requirements within this Clause.


Sub-Clause 8.5.5  Post-delivery activities – This sub-clause takes a previously stated requirement (8.5.1h) and adds more new requirements that were not found in the 2008 version.  Specifically 8.5.5 b), c) and e) introduce new requirements intended to ensure that the Customer is made aware of important factors concerning your products and services AFTER they have been provided by your organization.  There is a Note at the end of the Clause which states:  Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.


Sub-Clause 8.5.6  Control of changes – Although the requirements contained within this sub-clause were certainly implied in the old 2008 version, this sub-clause now makes it explicit.  Your organization needs to control any changes made either to the production processes, or the service processes.  Control means keeping records of what was changed,  who authorized the changes, that the changes were reviewed and determining if any action plans are necessary as a result of the review.



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.


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 8.5 of ISO 9001:2015?

A:  For Clause 8.5, a Gap Audit checklist should cover these areas:

–  Does the organization have documented information available on how the products/services/activities are to be carried out?  The results to be achieved?
–  Has the organization defined the availability and use of suitable monitoring and measuring resources?
–  Has the organization implemented monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for services, have been met?
–  Has the organization implemented the use of suitable infrastructure and environment for the operation of processes?
–  Has the organization appointed competent persons, including any required qualifications, for those persons providing products and services?
–  Has the organization implemented actions to prevent human error?  Examples?
–  Has does the organization identify and trace its products and services?  How?
–  Has does the organization protect property belonging to Customers?  Any intangible property?
–  Has does the organization protect property belonging to external providers? Any intangible property?
–  Has does the organization preserve services being provided to Customers?
–  How does the organization implement and control any post-delivery activities? Are there any potential undesired consequences associated with its products/services? Does the nature, use and lifetime of its products/services impact the extent of the post-delivery activities? Does Customer feedback impact these activities
–  Does the organization review and control changes to the processes for production and service provision? How is this done? Who can authorize these changes? Any actions taken as a result of the review of these changes?

(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!