Practical sheet | REF: FIC0646 V1

Monitor standards and regulations

Author: Michel GALIBERT

Publication date: December 10, 2011 | Lire en français

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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...

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Identify applicable standards and regulatory requirements