ISO 9001:2015 – Newsletter – Issue 12



Issue 12 – Clause 4.2:  Understanding the needs and expectations of interested parties


ISO 9001:2015…

Clause 4.2:  Understanding the needs and expectations of interested parties


What’s new in Clause 4.2?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 11) we discussed the term “context” which was found in the previous Clause, and now in Clause 4.2 we are introduced to another new phrase entitled “interested parties”.  Clause 4.2 is brand new in this 2015 edition of the Standard and I discussed it at a high level back in Newsletter Issue #3.

Let me start by making an observation regarding Clause 4.2… Notice that the title says “needs and expectations” but these words never show up within the Clause itself, but rather they are replaced with the word “requirements”.  This seems odd especially since “requirements” is a much more prescriptive word.  This is just another inconsistency similar to what I pointed out in the last Clause (see Newsletter Issue #11).

Here is another important fact, the phrase “documented information” does not exist within Clause 4.2, so you are free to simply verbally describe how your organization determines who the “interested parties” are to your QMS, and what their requirements are.  Again, if the Auditor sees this as a gap and wishes to pursue this further, they will be faced with demonstrating that a lack of “documented information” in this area somehow makes this particular QMS process, ineffective (see Clause 4.4.2).

Notice also the use of the word “relevant”… you get to decide which interested parties are relevant to your QMS, AND which of their requirements are relevant.  So lots of flexibility is provided in how you can address the requirements within this Clause.

As I said in my last Newsletter, this is another good example of how this new Standard differs from the old one… Auditors will now need to swim upstream, and downstream, and within each process (with perhaps only verbal evidence, along with their own observations), in order to assess whether the process is functioning, functioning as planned, and functioning effectively.  Many Auditors will find this to be a challenge, especially when sitting across the table from the business leaders in the company.


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


Clause 4.2: Understanding the needs and expectations of interested parties –  So who are the interested parties?  If your organization does do formal Strategic Planning then those groups that are external to your business (usually identified as part of the Opportunities & Threats discussions) are typically interested parties since they are impacted by the direction you take with “quality”.  If your organization doesn’t do formal business planning then the alternative is to handle this topic in a new section of your Quality Manual.

Let me repeat, this Clause can be addressed through verbal discussion/evidence however I suggest you consider building a table that lists your interested parties, with Customers being at the top of this list, followed by Vendors, Employees, etc, and don’t forget about accreditation bodies (your ISO Certification organization) and regulatory bodies connected to your QMS such as the DOT (for transportation of your products).  Next to each of these interested parties you can either list their relevant requirements and/or simply reference which Procedure within your QMS addresses their requirements.  This table of relevant interested parties (along with their associated relevant requirements) should be reviewed by the Management Team, finalized/approved and then re-visited by them once a year to keep this list up-to-date.



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 Training?

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 audit Clause 4.2 of ISO 9001:2015?

A:  For Clause 4.2, an Audit checklist should cover these areas:

–  Has the organization determined who are its interested parties to its QMS?  Is that documented anywhere?
–  Has the organization determined what the requirements are from its interested parties?  Is it documented?
–  Does the organization monitor who the interested parties are, and what their requirements are?
–  Does the organization review who the interested parties are, and what their requirements are?
–  What are the statutory and regulatory requirements that are applicable to the organization’s products and services?
–  Are statutory and regulatory requirements documented within the QMS?

(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!