Context of the Organisation

Context of the organisation is probably the most significant change in the new ISO 9001:2015 standard.  The clause itself is written as a process where the inputs are the requirements of the relevant interested parties, and the output, the scope and processes required to meet those requirements.

Your job is to firstly identify the relevant internal and external interested parties.  Some are fairly obvious (customers, suppliers, regulators) but other may not be.  For example, your staff are an internal interested party but what about the management team, the board or investors in your company?  Once you have agreed who the relevant interested parties are, you can then identify their requirements.  We know some will be more important than others.  For example, if you are in a regulated industry, failure to meet those regulations may put you out of business.  Therefore, those requirements are going to have a significant influence on the shape of your QMS.

Developing the scope of the QMS should be influenced by the issues, requirements and your products and services.  Once the scope is defined, the processes necessary to deliver those products and services to the appropriate standard are then required to be established, implemented, maintained and continuously improved.  There are some additional requirements for processes so make sure you review clause 4.4.1 in some detail.

At management review you are expected to review the interested party issues and requirements to ensure that your QMS remains relevant and focused on these key requirements.  Your Organisational Context may be fairly fixed, but if there are some changes, make sure the QMS takes these into consideration and remains relevant and effective.

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