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.