1. Identify applicable standards and regulatory requirements

In the context of a quality approach, what is the nature of the compliance expected?

• Firstly, that the quality management system complies with the standard used, such as ISO 9001.

• Secondly and most importantly, that the products and services supplied comply with the relevant legal and regulatory requirements.

It follows that you need to identify :

• standards applicable to your quality management system ;

• laws and regulations applicable to the products you manufacture.

The standards applicable to the quality management system may be, for example :

• ISO 9000 – Quality management systems – Essential principles...