ISO 9001:2015 – Newsletter – Issue 41



Issue 41 – Clause 4.3:  Determining the scope of the quality management system


ISO 9001:2015…

Clause 4.3:  Determining the scope of the quality management system


What’s the intent of Clause 4.3?… In our last Newsletter (ISO 9001:2015 Newsletter Issue 40) we discussed the topic of “interested parties”, and now here in Clause 4.3 we address the “scope of your quality management system”.  The intent of this Clause is to have organizations define what the boundaries are for the system they will use for managing the level of quality of their products… and the quality of their services.  The first two Clauses (4.1 and 4.2) helped to set the stage by establishing “context” of the marketplace you operate within and who is “interested” in the quality of your products and services.  The term “Scope” was previously found in the 2008 version, in Section 1.0, but in that case “Scope” was referring to scope of the document (the International Standard).  In the 2015 edition, Clause 4.3 is brand new in the Standard since it deals with the “Scope” of your organization’s quality management system (QMS).  Back in 2008, the ISO Certification Bodies required that “Scope” be stated on the certificate they issued to you, so they mandated that you define what your “Scope” was within your QMS.  This necessitated having the exact same wording shown somewhere, and in most cases companies placed it within their Quality Manual.  In the 2015 edition there is no specific requirement for a document called the Quality Manual, so organizations will need to decide where to “maintain this documented information of their Scope”.  Once again, I suggest that you retain your Quality Manual for many reasons as stated previously (see Newsletter Issue #3), and that this be where your company defines the boundaries or “Scope” of your QMS.
Note A:  This Clause DOES 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.  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 4.3  Determining the scope of the quality management system consists of zero (0) Sub-Clauses…

When determining Scope, organizations are expected to take into consideration the external and internal issues defined back in Clause 4.1, the requirements of those interested parties identified in Clause 4.2, as well as the products and services they want covered under the ISO umbrella.

Some companies may decide that only some products (or some services) will be included within their ISO-Registered quality management system, while others may decide only some business facilities are covered, or even some geographies.  No matter what approach you decide on using, just make sure that this is clearly articulated within your Scope statement.  You must also ensure that any Customers buying products or services not covered by your ISO Registration/Certification, know it before submitting their order.

Once Scope is decided, it needs to be documented, and this document must outline the types of products and the types of services that are included within it.  That Scope statement must also provide justification for any “shall” requirements that you determine are not applicable to your organization.  Any “not applicables” that you take must not prevent you from being able (or responsible) to supply conforming products and conforming services, nor negatively impact customer satisfaction (or stop you from enhancing their level of satisfaction).  The message is clear… tread carefully when deciding which requirements within the ISO 9001:2015 Standard do not apply to your business.  Ask yourself a question: “If you were sitting in a room with your top Customers, would any of them object to your taking a not-applicable on some parts of the ISO 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 4.3 of ISO 9001:2015?

A:  For Clause 4.3, an Audit Checklist should cover these areas:

– Has the organization determined the Scope of its QMS? Where is that documented?
– How was Context of the Organization (Clause 4.1) considered when defining the Scope Statement?
– How were Interested Parties (Clause 4.2) considered when defining the Scope Statement?
– Does the Scope Statement identify the types of products that are included?
– Does the Scope Statement identify the types of services that are included?
– Is every Customer order for products/services covered within the Scope statement? If some orders are not, are those Customers aware that their purchase falls outside the scope of the ISO registration?
– Were any Clauses considered to be “Not Applicable” to the organization? If yes, is the justification for doing so documented? Where?
– Do the justifications describe why conformity of products and conformity of services will not be affected? Is it made clear why Customers will not be impacted?
– Have these “Not Applicables” been verified as part of the internal audits conducted each year to ensure they remain valid?

(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!