IS0 9001:2015

Clause 4.3 Determining the scope of the Quality Management System

(Or as I prefer to term it – the Business Management System!)

ISO 9001:2015 requires the organisation to establish the scope of its QMS for its products and services. (These must not only encompass the internal functions of the organisation or specific sections thereof, but also include outsourced operations or processes – EG: Subcontractors.) There is also a specific requirement that when doing so, that the organisation must consider:

  1. Its external and internal context issues (see article 4.1)
  2. The requirements of relevant interested parties (see article 4.2)

The scope must be made available and be maintained as documented information. If exclusions have been applied, organisations must ensure that they are recorded and that the exclusion is stated and justified. (IE It is impossible to implement given the nature of the operations of the organisation AND that the exclusion does not adversely impact the organisation’s ability to supply conforming products and services / affect the enhancement of customer satisfaction.)

Note: The wording of the scope of the management system which you need to document, is not necessarily exactly the same at that which will appear on your ISO 9001 Certificate when it is awarded to you, but often is. Looking at similar organisations certificated online will therefore give you an idea of how one is usually worded.


An example of a typical exclusion might be a manufacturing organisation that does not design products and only accepts customer’s designs for manufacture.

Audit Check

Given that the latest revision of ISO 9001 is intended to make the standard more relevant to services orientated organisations, such businesses may wish to consider before excluding the design element, the processes they undertake when establishing new services to be tendered, as this can be interpreted as a design process which should be included in and come under the control of the management system.

This article is the property of David Barker Consulting © and is free for you to use. If you wish to reproduce elsewhere, please be so kind as to ask permission first and credit me as your source. If you need any further assistance, feel free to use my contacts page to get in touch and let me know how I can help!

David Barker CQP MCQI

ISO 9001:2015

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