ISO 9001:2015 – Newsletter – Issue 3



Issue 3 – Element 4.0: Context of the Organization


ISO 9001:2015… Element 4.0 Context of the Organization


What’s new in Element 4.0?… As I mentioned in my last Newsletter (ISO 9001:2015 Newsletter Issue 2), the current FDIS (Final Draft International Standard) version of the Standard will very likely remain unchanged when the official edition is published (late September).  With that in mind, I wanted to get started on analyzing it, section by section, so that you are able to start thinking about how you can begin your journey of upgrading your QMS (Quality Management System) to this revised Standard.  My plan is to make a first pass by circling the Standard at a high level so that we gain an overall perspective before getting overwhelmed in all of the details.  On that note, the next few Newsletters will cover each of the ISO 9001 Elements (see below), and once completed, I will circle back and dive into Clause 4.1 more thoroughly. 

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


Element 4.0 Context of the Organization consists of four (4) Clauses as listed below:

4.1  Understanding the Organization and its Context

4.2  Understanding the Needs and Expectations of Interested Parties

4.3  Determining the Scope of the Quality Management System (QMS)

4.4  Quality Management System and its Processes


What does “Context” mean?…

The old version of the Standard (ISO 9001:2008) simply jumped right in without spending much time trying to set the stage for all of the QMS details that would follow.  This revised edition steps back and begins by putting things into perspective (context) for you, hence the title of this Element.  You may have heard someone in the past use the phrase “let me put this into context for you” while telling a story… because without some background information then the details lose some of their meaning and importance.  NOTE: Keep in mind that it is explicitly stated within the Standard that it is entirely up to you to decide what “context” means for your organization…. so remember that if Auditors from the ISO Certification Bodies begin to make speeches about what THEY think “context” means for your company.


ISO 9001 and Business/Strategic Planning…

Business or Strategic Planning always had a home in “Management Responsibility” of the old version of the Standard, specifically within the Quality Objectives section.  In this newly revised ISO 9001:2015, business or strategic planning (which typically includes a SWOT Analysis – Strength, Weaknesses, Opportunities, Threats) covers the majority of what Clause 4.1 is asking for, and handles Element 6.0 (Planning) as well.  But what if your organization doesn’t do formal business or strategic planning?… Well, here you have a couple of choices, convince your management team to start doing it or find another way to comply.  Just so we are clear, I am a big believer in Strategic Planning (or Business Road-Mapping) because I have seen first-hand how companies were able to successfully navigate and grow, in a field full of competitors, by getting their Team to all row in the same direction (i.e. getting alignment and clarity on goals for the business)… pretty powerful tool from the results I’ve seen.


An alternative approach for addressing “context”…

Clause 4.1  Understanding the Organization and its Context:  Since many of you will need another option for handling “context”, I am going to suggest you consider using an alternative approach.  First of all, this alternative approach assumes that you will not scrap your current Quality Manual (even though it is no longer an ISO requirement).  Secondly, you need to be prepared to re-write a portion of your Quality Manual so that it includes a “Business/Strategic Planning” section that essentially outlines your business planning activities, looking at internal and external issues, and including a simplified SWOT analysis.  This may seem overwhelming but when I cover Clause 4.1 in more detail (in a future Newsletter) I will provide you with more information on how to handle this.  A draft of this new Quality Manual section can be prepared in advance of a Management Team meeting where it can be used to do some “training” with the Team as well as to finalize/approve this important section.  Thirdly, you’ll need to re-visit this new Quality Manual section at least once a year (perhaps at a Management Review Meeting?), so that the information regarding “context” can be updated, or re-confirmed as is.

There can obviously be many other approaches that will work, since every company is unique, with each performing various degrees of “formal strategic planning”.  So as always, how you address “context” depends very much on how your current planning process works (or doesn’t).


What else is needed for this Element?…

Clause 4.2 Understanding the Needs and Expectations of Interested Parties:  Once you’ve addressed “context” then you can identify those “interested parties” that are relevant to your business, and what their requirements are.  Again, if your organization doesn’t do formal business planning then the alternative is to handle this topic in that same new section of your Quality Manual that I mentioned above.  I see this as a table listing these interested parties, with Customers being at the top of this list.  Once again, this can be drafted up in advance, reviewed by the Management Team, finalized/approved and then re-visited by them once a year to keep this list up to date.

Clause 4.3 Determining the Scope of the QMS:  Determining “Scope” should be a natural next step after handling the previous two Clauses.  Nothing much has changed with the exception that “Not Applicables” need to be defined here and you are now allowed to take an N/A from any section of the Standard (as opposed to being restricted in the past).  However, before you get too excited, the wording in Clause 4.3 basically says that if it affects the Customer then you can’t take an N/A on it, period.  I’m actually a bit surprised that this change has not caused more discussion in blogs and internet forums since essentially the last paragraph of this Clause, along with the use of the term “products and services” throughout the Standard, implies that almost every organization will now need to address “Design” activities (at least for “services”) within their QMS.

Clause 4.4 QMS and its Processes:  Needless to say, all of the preceding Clauses need to be finalized in order to address the requirements within this one, which is for the most part a repeat of the 2008 version but with much more prescriptive wording.  For instance, some of the requirements within this Clause include determining inputs & outputs for each process, addressing risk & opportunities for each, and collecting evidence to show that each process is working as planned.

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 universe!).  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 (and fun) exercise.  This is a great way to engage upper management in taking more ownership of their QMS.


Make 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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Q: Since ISO 9001:2015 no longer requires a Quality Manual, should I delete it from the QMS? 

A: I know the temptation may be to scrap the Quality Manual since it will need to be revised to comply with ISO 9001:2015 but I recommend you keep it for a number of reasons.  One main reason for having a Quality Manual is that it provides the reader (your employees) with a blueprint on how you manage Quality in your company.  It helps them navigate around all of the processes you’ve decided to implement to ensure you deliver a Quality product and a Quality service to your Customers.  Another potential benefit I see is using it as a document to show how your company decided to address/interpret the requirements within the ISO 9001 Standard, which is helpful for both inside and outside readers (your Internal Auditors, your Customers, your Suppliers, your ISO Certification Auditors).  As I’ve said before this 2015 revision is an opportunity to connect your QMS much closer to your business so consider not just scrapping the Quality Manual but rather re-building it into a more business/practical document by using only a handful of main content pages, followed by a few Appendices as reference material.


Until next time…

Tim Renaud

Helping Business Professionals Reduce Risk and Remove Waste!