ISO 9001:2015 – Clause 4


CONTEXT OF THE ORGANISATION

4.1 Understanding

This clause is looking to require companies to identify, monitor and review issues that are relevant to the organisation in terms of its performance that could have an impact on its quality management system.

Most successful businesses will already be monitoring such issues; however they are now required to provide evidence of this for assessment purposes.

4.2 Understanding the needs and expectations of interested parties

Organisations are being asked to identify ‘relevant requirements’ or ‘relevant interested parties’ and, once identified, monitor and review such information.

Interested parties could be groups or individuals, (such as suppliers, employees, shareholders, neighbours, etc.) who could impact on the organisation’s ability to provide the product and/or service that meet their customer’s requirements, as well as those of any legal and regulatory nature.

As with the Clause above most successful businesses will already be monitoring their interested parties, but they are now required to provide evidence of this for assessment purposes.

4.3 Determining the scope of the quality management system

The scope of the quality management system (QMS) sets its boundaries, identifying what requirements of the QMS are applicable to and what are not. It should be done with consideration of the organisation’s context (what your company does, what it wants to achieve, who you supply to, etc.) as well as the products and/or services it supplies; the scope shall be documented.

4.4 Quality management system and its processes

This clause requires organisations to establish processes that, once established, are maintained and continually improved. Organisations are also asked to set performance indicators that enable the effective operation and control of the processes established by the organisation.