ISO9001 UPDATE – Clause 4

BY Rebecca Randles ON 2nd February 2015.

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Clause 4

CONTEXT OF THE ORGANISATION

4.1 Understanding  

The draft is looking to require organisations to identify, monitor and review both internal and external issues that are relevant to the organisation in terms of its strategic direction that could have an impact on the performance outcome of the 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 determine ‘relevant requirements’ or ‘relevant interested parties’ and once determined monitor and review such information.

Interested parties could be groups or individuals who have an ability to impact 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, 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 as well as the products and/or services it supplies; the scope shall be documented.

4.4 Quality management system and its processes

The draft requires organisations to establish a process based quality management system that once established is maintained and continually improved. Organisations are also asked to determine performance indicators that enable the effective operation and control of the processes established by the organisation. The processes adopted shall be documented and given as evidence at assessment.