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...
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Identify applicable standards and regulatory requirements
Obtain standards, laws and regulations
ToolReference standards
ISO 9000 "Quality management systems. Essential principles and vocabulary".
ISO 9004 "Managing the sustainable performance of an organization. Quality management approach".
ISO 9001 "Quality management systems" – Requirements
ISO 19011 "Guidelines for auditing management systems".
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