ISO 9001:2015 – Newsletter – Issue 8



Issue 8 – Element 8.0:  Operation


ISO 9001:2015…

Element 8.0 – Operation


What’s new in Element 8.0?… We covered the “support” activities in my last Newsletter (ISO 9001:2015 Newsletter Issue 7), and this “support” is now directed towards your main “operations”, which is the focus of Element 8.0 (Operation).  This Element is by far the largest of all the Elements and combines a number of requirements from the previous 2008 version. The biggest change being Clause 8.3 (Design and development of products and services), since it is now clear that “services” and “service processes” need to be designed and not left to chance.  I had mentioned this change in earlier Newsletters because many organizations take a “not applicable” on Design and they now need to re-think that decision for those services they provide to their Customers.  This really shouldn’t be a major hurdle since many companies already have implemented structure into their service delivery processes but just have not referenced them inside their Quality Management System (QMS).


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 8.0 Operation consists of seven (7) Clauses as listed below:

8.1  Operational planning and control

8.2  Requirements for products and services

8.3  Design and development of products and services

8.4  Control of externally provided processes, products and services

8.5  Production and service provision

8.6  Release of products and services

8.7  Control of nonconforming outputs


Clause 8.1  Operational planning and control – This Clause re-states similar requirements for planning and control from the 2008 version but with a few key differences.  The first one being that these requirements now apply to all processes identified within your QMS and not just the product realization processes.  This was implied in 2008 and now they’ve made it much clearer.  The other change deals with managing the risks associated with “changes” you make to any of your QMS processes, as well as action plans to mitigate any adverse effects from those changes.


Clause 8.2  Requirements for products and services:  This Clause contains four (4) sub-clauses, Sub-Clause 8.2.1 (Customer communication), Sub-Clause 8.2.2 (Determining the requirements related to products and services), Sub-Clause 8.2.3 (Review of requirements related to products and services), and Sub-Clause 8.2.4 (Changes to requirements for products and services).  After a careful review of Clause 8.2, a few key items come to the surface.  The first being that they use two separate “shall” requirements to make it abundantly clear that you should not accept an Order from a Customer unless you are convinced that you can deliver it (both the product and the service) to their satisfaction.   The number of nonconformances generated will be an indicator of how often you break your promise to the Customer.  The other key item in this Clause is again the concept of “services”.  You need to also review your ability to make good on all of the “services” that you also promise to the Customer.  As I said in an earlier Newsletter, the best way to make sure that “services” are being addressed properly within your QMS, is to develop a listing of all the “services” that your Customers expect from your organization, then use that list to guide you as you dive into each of the Clauses of this new Standard.


Clause 8.3  Design and development of products and services:  This Clause contains six (6) sub-clauses, Sub-Clause 8.3.1 (General), Sub-Clause 8.3.2 (Design and development planning), Sub-Clause 8.3.3 (Design and development inputs), Sub-Clause 8.3.4 (Design and development controls), Sub-Clause 8.3.5 (Design and development outputs) and Sub-Clause 8.3.6 (Design and development changes).  Clause 8.3 has all of the previous requirements from 2008, along with some minor changes, the most significant of which is the mention of “Customer” throughout, as well as managing any risks associated from adverse effects of design changes.  Of course, I’ve already mentioned above about handling design of “services”, which is now expected within this Clause.


Clause 8.4  Control of externally provided processes, products and services:  This Clause contains three (3) sub-clauses, Sub-Clause 8.4.1 (General), Sub-Clause 8.4.2 (Type and extent of control) and Sub-Clause 8.4.3 (Information for external providers).  The biggest change here is the switch from the term “supplier” to “external provider”, and so the word “purchasing” is no longer found within the ISO 9001:2015 Standard (except in Annex A.8).  Also, the 2008 version was “product” focused and as you can see this has now grown to “products, services & processes”.  So although the requirements within Clause 8.4 remain essentially the same as 2008 (albeit there are more of them and they are more prescriptive), the scope is much broader since it encompasses many more activities, with many more players, regardless of whether money actually changes hands (i.e. Vendors; Corporate Headquarters; Sister Plants/Facilities; Shared Services; Other Depts; Joint Ventures; Associations; etc).


Clause 8.5  Production and service provision:  This Clause contains six (6) sub-clauses, Sub-Clause 8.5.1 (Control of production and service provision), Sub-Clause 8.5.2 (Identification and traceability), Sub-Clause 8.5.3 (Property belonging to customers or external providers), Sub-Clause 8.5.4 (Preservation), Sub-Clause 8.5.5 (Post-delivery activities) and Sub-Clause 8.5.6 (Control of changes).  One of the changes found here is in Sub-Clause 8.5.1 g) which asks you to include “mistake proofing” as part of your control techniques.  They do however use the wording “as applicable” so it will be up to each organization to decide whether to make use of this excellent tool.  Another change is contained within Sub-Clause 8.5.3 which now includes “property” supplied by external providers, and not just Customers.  Sub-Clause 8.5.5 c) is interesting in that it asks you to consider the life cycle of your products and services.  Finally, Sub-Clause 8.5.6 includes new requirements pertaining to managing changes made in your Operations.


Clause 8.6  Release of products and services  – This Clause is essentially the same as the previous 2008 version, with very few changes.


Clause 8.7  Control of nonconforming outputs  – This Clause starts off by using a title that makes use of the term “outputs”, which ensures that you don’t forget about “services” being supplied to your Customers.   In the past, this area of the Standard typically only dealt with a limited number of nonconformance types or categories, and they were primarily product related.  Otherwise, the requirements found within this Clause are similar to the 2008 version.



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: Besides Vendors, how do I determine who our “external providers” are?

A:  I would suggest you consider arranging a meeting or conference call with some of the key players within your organization and then together brainstorm a list of externally provided processes, products and services.  Next to each one, identify who (individual name or group) that provides it.  Test your list by considering activities that are addressed within your QMS but whose responsibility lies outside your facility/office.  You can also do a search of your QMS documentation for any links or references to outside groups or individuals who perform an activity defined within your QMS.  Once the list settles down then add another column describing how each of them are controlled and what records would be generated, if any.


Until next time…

Tim Renaud

Helping Business Professionals Reduce Risk and Remove Waste!