ISO 9001:2015 – Newsletter – Issue 40



Issue 40 – 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 the intent of Clause 4.2?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 39) we discussed the topic of “context of the organization”, and now here in Clause 4.2 we address the new term called “interested parties”.  Once you’ve addressed “context” then you can identify those “parties that have an interest” in the level of quality your business provides… and then how their “interests” get translated into relevant requirements within your Quality Management System (QMS).
This Clause is another good example (much like the previous Clause) 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.
Note A:  This Clause DOES NOT include requirements for “documented information”.
Note B:  As some of you already know, 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 training workshops and gap audits, where the requirements of the Standard have to be interpreted and applied to each unique situation.  Combining an on-site Gap Audit with ISO 9001:2015 Essentials Training, has become our most popular request for proposal from our Newsletter readers, because the first step in making the transition is to understand how big of a gap needs to be closed.  Another popular training request is our on-site Internal Process Auditor Training for ISO 9001:2015 since you will need to do a complete round of internal audits to the new Standard prior to your external upgrade audit (see below).  On that note, some organizations are opting to outsource their internal audits in order to meet deadlines (…more details on this service, as well as the training sessions 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 4.2  Understanding the needs and expectations of interested parties consists of zero (0) Sub-Clauses…

The primary intent of this Clause is to identify what types of organizations (or groups) have an obvious and specific interest in the quality of your products, and the quality of your services, either because the level of quality impacts them directly, or because they provide some type of oversight in the marketplace (such as through a government agency).  By default they then become an “interested party” in how you manage Quality (via your QMS).  You’ll note that within this Clause the use of the word “relevant”… which means you get to decide which interested parties are relevant to your quality management system… AND which of their requirements are relevant.   So lots of flexibility is provided in how you can address the requirements within this Clause.

Speaking of flexibility, remember that 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 documentation 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).

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 may be impacted by the strategic direction you take with your business and its subsequent effect on “Quality”.  Whether you conduct formal business planning activities or not, I suggest you address Clause 4.2 with a new paragraph or section within 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, etc… and don’t forget about accreditation bodies (your ISO Certification organization) and regulatory bodies that have a specific interest in the quality of your product or the quality of your service.  For many organizations, there will be no statutory nor regulatory bodies connected to the quality (not safety) of your products and services.  Some organizations view the Department or Ministry of Transportation to be an Interested Party (for their Delivery Service) even though their regulations are focused on the safe movement of goods on the roads, because if the transport vehicle is pulled off the road for any safety violations, this situation will likely have a negative impact on Customer delivery requirements.  Next to each of these interested parties you can either list their relevant requirements and/or simply reference which Procedure or Work Instruction 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.  This can be accomplished nicely during the Quality Manual review cycle, or as part of the Management Review process.


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, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy Internal Audit requirements within the ISO Standards.


Documentation Development Training Workshop for ISO 9001:2015

This Documentation Development Training Workshop for ISO 9001:2015 Session is intended to be a very interactive, hands-on session (hence the name Workshop) where your QMS documentation will be created/revised, with guidance from an experienced facilitator.  This type of session can help launch your transition efforts by getting a lot accomplished within a compressed time-frame.  If your organization has already begun the re-write then this session can be used to validate what you’ve accomplished so far, or if you haven’t yet begun, it can be the catalyst to get things started (…which is usually the hardest part).  Deciding how to move from your current QMS structure into a new one can be a daunting task and this session can help you navigate through it.  A copy of a sample Quality Manual (re-iterating the “shall” requirements found within the ISO 9001:2015 Standard) will be provided to each participant.  As always, our focus will be on how to develop a simplified and streamlined quality management system, that helps to drive improvement in your business.


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 an audit for 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 it documented?  Where?
–  Has the organization determined what the requirements are from its interested parties?  Is it documented?
–  Does the organization monitor and review who the interested parties are, and what their requirements are?
–  What are the statutory and regulatory requirements that are applicable to the quality of the organization’s products and services?
–  Are statutory and regulatory requirements documented within the QMS? Are the associated regulatory bodies listed as Interested Parties?

(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!