ISO9001:2015 Clause 4.3 is all about the scope of your Quality Management System, of what parts of your organisation will be included within your Quality Management System, in other words what are the boundaries of the Quality System. By completing ISO9001:2015 Clauses 4.1(Context of the Organisation) , Clause 4.2(Interested parties) and Clause 4.4 (Quality Management System Processes) in advance of looking at the scope you should now be in a place to let you outline the Quality Management System Scope effectively.
Considering your Quality Management System Boundaries
You have the ability to effectively ring fence the parts of your organisation that will be in or out of the Quality Management System, ISO9001:2015 Clause 4.3 is where you do this.
Here are some examples of the considerations you should make about the scope
- The range of Products and Services, are they all in or only some?
- External support, or outsourced services or products may be something you decide not to include
- Sites or Locations, your organisation may have more than 1 location but you only want to include the manufacturing organisation and not the sales office for example
- Centralised functions may be something that you consider for example IT services for the organisation maybe something you decide not to include
Documenting the Scope
Since you have been through Clauses 4.1, 4.2 & 4.4 you will have documented all the thinking that will go into your Scope section, this is an important requirement as it lets you explain the Scope you have selected to anyone within the organisation, clients and of course the all important ISO9001:2015 auditor
The actual description of the scope doesn't have to be that long, in fact the shorter the better because it should be clearer, don't inject a whole bunch of flowery adjectives and clever talk just nice simple plain English. Some Examples of an ISO9001:2015 Scope are:
- "The scope is: provision of marketing, sales, support, development and implementation of software solutions for emergency services. Location Unit 42, 99 Letsbe Avenue, Christchurch, New Zealand.
- The Scope is: Provision of manufacturing, planning & purchasing support for electronics organisations. Location: 77 Bright Spark Way, Wellington, New Zealand
- Exclusions of the ISO 9001:2015 standard: Clause 8.3, All Design of electronic products are provided to us by our customers, XYZ Ltd is only providing manufacturing assembly services of provided designed.
- Exclusions of the ISO 9001:2015 standard, Purchasing - All materials are supplied by clients free as part of the agreements.
Polishing the Scope
If you are a regular reader of the site you will know that I hate the polishing or word smithing of documentation, there is just no need for it. It's the same here with your scope, make your best attempt at it and then accept it. As part of your continuous improvement cycle built into your new ISO9001:2015 system you will review the scope anyway so by all means tweak it as you go when review time comes round, but don't hold up the implementation trying to decide if that is the very best adjective to describe what you do, keep it simple!