1. Identify applicable standards and regulatory requirements
In the context of an ISO 9001 quality approach, what is the nature of the conformity expected?
First: that the quality management system complies with ISO 9001.
Secondly: that the products delivered comply with the relevant legal and regulatory requirements; remember that the term "product" refers generically to both physical products and services.
It follows that you need to identify :
The following standards apply to the quality management system:
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Identify applicable standards and regulatory requirements