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 :

• standards applicable to your quality management system ;

• laws and regulations applicable to the products you manufacture.

The following standards apply to the quality management system:

• ISO 9000:2005 – Quality management systems...