ISO 9001:2015 – Newsletter – Issue 42



Issue 42 – Clause 4.4:  Quality management system and its processes


ISO 9001:2015…

Clause 4.4:  Quality management system and its processes


What’s the intent of Clause 4.4?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 41) we discussed the topic of “Scope of your QMS”, and now here in Clause 4.4 we address “your quality management system itself”.  The intent of this Clause is to have organizations actually build and install a quality management system (QMS) that will manage the level of quality provided to your Customers.  All of the preceding Clauses (4.1; 4.2; 4.3) need to be finalized in order to address the requirements within this one.  To give you some perspective on how far reaching Clause 4.4 is, as an Auditor I like to audit this Clause last since I need to see all of the other parts of the QMS before I can decide if this Clause has been addressed.

The ISO 9001 Standard includes a diagram (see section 0.3.2, Figure 2 of ISO 9001:2015) that depicts how the main Elements connect to each other in a Plan-Do-Check-Act cycle.  Many organizations will simply “borrow” this flowchart and call it their own, to address Clause 4.4 however by doing so they will miss an opportunity to finally connect their real business activities to their QMS (instead of running it in a parallel fashion).  At the very, very least, developing your own business process flowchart would give you something to show the Auditors (both internal and external) about how your organization actually functions.  What I am talking about here is a high level diagram showing your main business processes (no more than 6 to 10), and how they connect or flow from one to the other.  Add in references to the main Elements of the ISO 9001:2015 Standard and you’ve now connected the dots for the External Auditors.  Creating this document can be an eye opening exercise and is a great way to engage upper management in taking more ownership of their QMS.

Note A:  This Clause DOES include requirements for “documented information”.
Note B:  In case you were wondering, 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 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.  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 4.4  Quality management system and its processes consists of two (2) Sub-Clauses as listed below:

4.4.1 [no title] The organization shall establish, implement…

4.4.2 [no title] To the extent necessary, the organization shall…


Sub-Clause 4.4.1 – This sub-clause begins by asking you to establish (build), implement (install), maintain (keep it up-to-date) and continually improve it (make it better).  It goes on to make a point of saying that your QMS needs to include processes and their interactions.  I view any management system as a network of interconnected processes, and a system to manage quality (your QMS) would be no different.  The listing of items in sub-clause 4.4.1 (a) to (h), are all focused on those processes you’ve identified within your QMS.

Sub-Clause 4.4.1 (a) asks the organization to determine the inputs required and outputs expected from these processes, with sub-clause 4.4.1 (b) asking how these processes are ordered or sequenced (which is first, which is second, and so on), as well as how they connect (interact) with one another .  Items (a) and (b) can be handled with written descriptions for each of your processes, or you can build a more detailed diagram that supports the high level one (6 to 10 boxes) we discussed above.  This more detailed flow diagram should take each of the high level boxes and break each of them down further into 3 to 5 boxes.  What you end up with is a more detailed diagram with about 30 to 50 boxes.  This map of your business processes will be useful for those reading your QMS documentation, when they try to understand all the activities involved in managing quality in your organization.

Sub-Clause 4.4.1 (c) wants to know how you will monitor and measure each of your QMS processes so as to keep them operating and under control.  Process measurements should include performance indicators (KPI’s or Key Performance Indicators), if they exist.  If the detailed process diagram we mentioned above is used in your organization, then simply add references to each box to indicate what document(s) provide more information on your monitoring and measuring activities.

Sub-Clause 4.4.1 (d) wants you to determine what resources (time, people, money, information, equipment, materials) are needed to operate these processes, and then make sure these resources are made available.  Consider making a reference to Clause 7.1 (Resources) in your QMS since it covers resources as well.

Sub-Clause 4.4.1 (e) asks you to define who is responsible, and who has the authority over each of these processes, in this case Clause 5.3 (Organizational roles, responsibilities and authorities) should be referenced in your QMS since it addresses the same topic.

Sub-Clause 4.4.1 (f) wants organizations to connect “risks and opportunities” to each of their QMS processes, and my advice here would be to simply reference Clause 6.1 (Actions to address risks and opportunities) within your QMS.

Sub-Clause 4.4.1 (g) wants you to review the data you collect from Item (c) and then evaluate the results to see if the QMS processes achieved their “intended results“, and if not, then implement changes to ensure they do.  Consider referencing the management review process in your QMS since it should handle Item (g) nicely.  One last comment… during the course of conducting audits I will sometimes ask leaders, as well as front-line employees, this question: “What are the intended results you expect from your QMS?”… most people have to ponder that question for a moment since not many have thought about it… I’ve heard many different answers over the years… always hoping that the first response will be “Satisfied Customers!”.

Sub-Clause 4.4.1 (h) asks organizations to find ways to improve all of the processes within it’s QMS, including improving the QMS itself.  You can reference Element 10.0 (Improvement) in your QMS since it will cover this topic in more depth.


Sub-Clause 4.4.2 – The question of how much needs to be documented is answered by this sub-clause because it provides you with the flexibility to decide how much, or how little, documentation your QMS needs, to function effectively.  Sub-Clause 4.4.2 (a) uses the term “maintain documented information” to support the operation of your processes, whereas Sub-Clause 4.4.2 (b) says “retain documented information” to provide confidence that your processes are working properly.  These terms are translated for you in Annex A.6 whereby “maintain” is equivalent to the old “control of documents”, and “retain” is the same as the old “control of records”, found in the 2008 version of the ISO 9001 Standard.


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 4.4 of ISO 9001:2015?

A:  For Clause 4.4, an Audit Checklist should cover these areas:

– Has the organization established and implemented their QMS?
– Has the organization maintained their QMS? How?
– Has the organization improved their QMS? How?
– Has the organization determined the processes needed for its QMS?
– Has the organization determined the inputs required and the outputs expected from these processes?
– Has the organization determined the sequence and interaction of these processes?
– Have monitoring and measuring criteria (along with performance indicators) been identified for each of the QMS processes?
– Has the organization determined the resources needed for these processes? Have they been made available?
– Have authorities and responsibilities been assigned to each of the QMS processes?
– How do the QMS processes address risks and opportunities (ref Clause 6.1)?
– Has the organization evaluated these processes against intended results? Have changes been implemented when results are not achieved?
– Has the organization improved these processes? Improved the QMS? How?
– What QMS documented information does the organization maintain? (control of documents)
– What QMS documented information does the organization retain? (control of records)

(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!