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  • Writer's picturePhil Potter

ISO 9001:2015 Clause 4 – Context of the Organisation

This is a new clause but lines up nicely with your 2015 version of the Environmental Standards systems and your ISO 45001:2018 Quality Standards or your IMS/QHSE systems.

This clause is broken up into the following four sections:

1. Understanding the organization and its context

What do you do and what are the issues you face in conducting your business. These can be positive and negative and can include conditions, characteristics or changing circumstances that can effect your Quality System.


External issues: Financial, legal, cultural, political, technological.

Internal issues: The existing Quality culture in the organization, perceptions and values of workers, information and documentation, working conditions.

2. Understanding the needs and expectations of workers and other interested parties.

Do you understand the needs and expectations of your workers, clients, suppliers, subcontractors and what regulatory and statutory requirements do you have to meet.

There can be a lot to understand here, so to further break it down you can refer to this weeks free resource. This resource identifies the needs and expectations of owners/shareholders, staff, customers/clients, regulators and the wider community. It is very useful.

3. Determining the scope of your Quality management system

How do you determine your scope, what do you do? You may be operating in the transport industry, as an architect, or manufacturer. You need to define the boundaries and applicability of the Quality System.

You will be required to state the scope you are operating in, as well as the products and services covered here. If the organisation is operating out of more than one facility, this will need to be taken into consideration when determining the scope.

4. Quality Management System

You need to commit to establishing, implementing, maintaining and continually improving your Quality Management System.

The key to this requirement is to what level you will integrate your Quality system into the business processes. Quality isn’t just the job for the Quality person or team it should be the responsibility of everybody.


Remember to download the free resource for this week; Needs and expectations of interested parties.

Any questions just contact us through the website.



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