ISO 9001 Clause 4.3 – Determining the Scope of the Quality Management System

In December 2021, the International Organisation for Standardisation (the main ISO body) reported “over one million companies and organizations in over 170 countries certified to ISO 9001:2015”. What’s more, this number continues to increase year on year for many and varied good reasons.

But there’s one not so small catch… ISO 9001 might just be the most confusing document in business history!

The good news is this series of articles and accompanying free factsheets are purpose designed to:

• Cut through the jargon
• Debunk the myths
• Make smoother sailing of your journey to certification

So, without further ado, let’s dive straight into ISO 9001 Clause 4.3 – How to determine the scope of your quality management system.

What Does “Determining the Scope of the Quality Management System” in ISO 9001 Clause 4.3 Mean?

ISO 9001 Clause 4.3 is all about the scope of your Quality Management System (QMS). It requires you to specify which parts of your organisation will be included in your QMS, plus any that won’t be. Admittedly, it’s not the most interesting clause. It’s more of a technicality than anything else. But it’s brilliant for helping you define boundaries.

The preceding two clauses of the standard provided you with the raw materials for determining the scope. Now, ISO 9001 Clause 4.3 asks you to decide what’s included and what’s not, based on your understanding of two crucial elements, which are:

• The context of the organisation
• The needs and expectations of interested parties

In simplistic terms, the scope of your QMS is its boundary. And this boundary is informed and dictated by the following two factors:

1. The segments of your business to be included in your QMS - Perhaps you’re looking for only one site of your business to be included in your QMS. Or for a specific function to be excluded. ISO 9001 Clause 4.3 equips you to ring fence parts of your organisation that will be in or out of the scope of your QMS.
2. The requirements of ISO 9001:2015 that apply to your business. All ISO 9001 clause requirements are intended to apply. But they can be excluded if the requirements simply aren’t relevant to your business, in which case they don’t need to be in place for the sake of it. For example, take Design and Development or Calibrated Equipment. If your business doesn’t design or doesn’t use calibrated equipment, there’s no point having clause requirements relating to them. Instead, these clause requirements can be excluded from the scope with a justification statement that explains why they aren’t applicable in your business specifically.

Documenting the Scope of your Quality Management System

It might not seem like the most awe-inspiring part of the process. But truthfully, defining the scope is so important to certification for the following reasons:

• Internally - Scope communicates within your business which departments and processes must adhere to the QMS
• Externally - Scope tells the certification body which parts of your business will be audited and will also be displayed on your certificate

Thankfully, documenting the scope in ISO 9001 Clause 4.3 doesn’t need to be long and arduous task. Chapter and verse aren’t called for, just a statement in plain English, describing any exclusions or boundaries identified. Here’s some examples that show just how quick and simple it needs to be:

• For a security business - “The design, installation and maintenance of CCTV, access control and intruder systems”
• For an architectural practice - “The provision of full architectural services and professional client advise for public, private and commercial sectors”

And what about if you’re planning to exclude any irrelevant clauses? This is also where they’ll be documented. For example:

• Clause 8.3 – Design and development of products and services. The organisation does not perform any design of its products or services, all designs are provided by our customers.
• Clause 7.1.5.2 – Measurement Traceability. The organisation does not use any equipment requiring calibration.

You must maintain the scope of your QMS as documented information, which can be in your QMS manual if you’ve got one, or a version-controlled document as part of your QMS.

The scope of your management system ISO 9001 Clause 4.3 gets reviewed by your certification body at Stage 1 audit. So, my advice is this – Don’t hold up implementation agonising over the best adjectives to describe what you do. Keep it clear not clever.