Inside ISO 9001! The Scope (Clause 4.3) of the QMS

By Bob Collins

Consultant Editor; QMS ISO 9001 at Sentio Voci Ltd, Wimborne

Achieving ISO 9001 certification is a game-changer for any engineering or technology company. It proves to customers and stakeholders that an organization meets the highest standards for quality, safety and reliability management.

It’s a complex path. So, can small and medium businesses navigate it without overextending their resources?

It has to start with a clear understanding of the company's goals and how a quality management system will fit into the daily operations.

That’s easier said than done, and for a start-up or small enterprise it may be in unknown territory.

Decisions have to be made early; what functions of the business are to be included in the quality management system, (QMS), e.g., are Marketing or the Accounts functions included?

The key phrase is the Scope, (Clause 4.3 of the specification). It has to be defined in the QMS documentation.  What’s in and what’s excluded from the QMS. Those operations that fall within the scope must be documented, controlled and periodically reviewed for improvement. The scope of the QMS might include the Design process, if you manufacture as well as the Production Process.

For example, Supply Chain and Supplier Management as well as Test and Inspection and maybe post-delivery support would be within the scope.

ISO 9001:2015 allows for justified exclusions, but only if they do not impact the capability to provide conforming products and/or services; (e.g., tax compliance or employment law)

What is to be excluded from the scope has to be justified within the QMS.

It has to explicitly state any exclusions considered appropriate. This ensures transparency and compliance with the standard while providing clarity to auditors, customers, and stakeholders about the scope of the QMS.

Another example of exclusion might for example be IT infrastructure support that does not directly affect the operation or monitoring of QMS processes.

In short - the boundary of the QMS must be clear and unambiguous. Exclusions should be identified by clauses in the standard.

Example of Exclusion declaration:

The scope of the Quality Management System for [Company Name] covers the design, manufacture, and post-delivery support of heavy-lift drone aircraft. The requirements of Clause 8.3 (Design and Development) are excluded, as the company manufactures products solely based on customer-supplied designs. This exclusion does not affect the organization’s ability to meet customer and regulatory requirements.

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At https://sentiovoci.co.uk, or email sentiovoci@gmail.com