Use of information from ISO 9001 Clauses 4.1 and 4.2


Quite Involved in Discussions
So...i fulfilled the requirements of 4.1 (determine context etc.) and 4.2 (interested parties etc.)....
How do I use the information obtained throughout the implementation process of ISO 9001?


Quite Involved in Discussions
The information you gather under 4.1 & 4.2 should set the scene for the rest of the system. Will it be a complex manufacturing system which requires lots of documented procedures and instructions or will it be a simple system which is going to be delivered via desktop and/or mobile devices and requires very little by way of written procedures.

It is the backdrop to the type of system you are about to prepare (or update).

Cari Spears

Super Moderator
Super Moderator
And in ensuring that customer and regulatory requirements are flowed down through the supply chain.


Quality Objectives>Context>Stakeholder (interested parties) analysis>SWOT>Key QMS risks>Management Review

Jen Kirley

Quality and Auditing Expert
The order of first 4 elements is debatable....
I suppose, but without identifying your interested parties and issues, how is the scope to be properly defined? I mean, we can always say "We manufacture XYZ" but 4.3 is asking us to now use the scope statement to identify which clauses do not apply to our QMS and why; to do that, what was listed in 4.1 and 4.2 gets considered.

A review of the standard finds 4.1 and 4.2 specifically referred to in 4.3 Scope, 6.1.1 Actions to address risks and opportunities, section A.4 describing Risk-based thinking. Following that, it seems it might be useful to consider what is listed in 4.1 and 4.2 in Management review (which cites 6.1, which is then linked to 4.2 and 4.2), as well as 4.4.1 Quality management system and its processes for the same reason.

In short, 4.1 and 4.2 help to provide the foundation of the QMS.
Top Bottom