ISO 9001:2015 – Newsletter – Issue 26



Issue 26 – Clause 8.1:  Operational Planning and Control


ISO 9001:2015…

Clause 8.1: Operational Planning and Control


What’s new in Clause 8.1?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 25) we discussed the topic of “documented information”, and now here in Clause 8.1 we move into Element 8.0 (Operation) and address the first Clause within it, dealing with “planning and control”.
Note A:  This Clause DOES include a requirement for “documented information”.
Note B:  For those of you who may not be aware, 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).
Note C:  It was exactly one (1) year ago this month that the new ISO 14001:2015 was released… and just like for ISO 9001, we are now down to two (2) years before all existing ISO 14001 registered companies need to get re-certified!


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 8.1  Operational Planning and Control consists of zero (0) Sub-Clauses.

The title of this Clause says “planning and control of operations” and it is very similar to what was found in the old 2008 version (Planning of Product Realization), and the intent here is the same… “plan” how you will produce your products and provide your services IN ADVANCE of taking a Customer order.  They’ve added some new words such as “services”, “planned changes”, “unintended changes”, as well as making a reference to actions determined back in Element 6.0 (Planning).

Clause 8.1 spells out all of the activities an organization should undertake to instill confidence that there is “plan” in place to handle Customers, and a way to “control” that plan.  For existing products your “plans” and “controls” are already implemented so you should start by auditing the “shall” requirements to make sure nothing has been missed, and then simply refer to these “plans and controls” in order to address the requirements within this Clause.

What you need to keep an eye out for in Clause 8.1 is those “services” you listed way back in Clause 4.3 (Determining the scope of the quality management system).  Lets be very clear here… I am talking about outbound services directed at your Customers.  Each of those services need to have a corresponding “plan” and associated “controls”.  If your “services” have been in existence for some time, then you likely have them described within your current QMS documentation, if not, then you will have to add them in.

Once you’ve addressed BOTH your products AND services (…and don’t forget about “plans and controls” for outsourced processes… hint: how you address Clause 8.4 will be the way to deal with this), then you can now look at how you handle “changes”, both planned and unintended.  Although handling changes was implied in the old 2008 version, they have made it more explicit this time.  The idea here is that if “planned changes” occur within your QMS processes, then decide how you will “control” them, since you know about them in advance… and if “unintended changes” occur, then how will you review their consequences, including what actions you will take in order to mitigate any adverse effects.

What “changes” are we talking about?  Well, based on the wording in the first sentence of Clause 8.1, you could assume it first applies to any QMS process changes that are needed to meet product/service requirements… and secondly, any changes to QMS processes needed to implement the actions you determined back in Clause 6.1 (Actions to address risks and opportunities).

One last point to keep in mind, Clause 8.1 also applies to brand new products that you introduce, as well as any new services launched.  The trigger here would be if you revise your Scope Statement.


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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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.


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Q:  How do you perform a gap audit for Clause 8.1 of ISO 9001:2015?

A:  For Clause 8.1, a Gap Audit checklist should cover these areas:

–  How does the organization plan and control the QMS processes needed to provide those services listed within its Scope?
–  How does the organization plan and control the QMS processes needed to implement those actions identified in Clause 6.1?
–  How does the organization control any planned changes to the QMS processes?
–  How does the organization review the consequences of any unintended changes to the QMS processes?  Are actions taken to mitigate any adverse effects?
–  Has the organization added any products or services to its QMS Scope?  If yes, how does the organization ensure planning and control is implemented for these added products or services?

(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!