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ČSN EN ISO 13485 ed. 2:2016

THE STANDARD PRINCIPLE

The Standard defines the requirements for quality management system in production and distribution of medical devices and establishes specific requirements in areas specific to this field, e.g. sterilisation, technical documentation, traceability). In its structure it follows up the requirements of ISO 9001.

HISTORY

Due to the growing emphasis on quality management systems of manufacturers and suppliers of medical devices, in 2001 the Standard ISO 13485 was compiled, which extended on the original Standard ISO 9001 specifying the requirements for production of medical devices.

BENEFITS FOR ORGANIZATIONS

OUR EVALUATION OF THE STANDARD

The Standard joins the advantages of the general Standard ISO 9001 and of the requirements for a specific field. It is a quality tool serving as the basis for demonstration of product conformity with EU directives.

 

 

 

Who can you reach out to?

Alois Randýsek

Alois Randýsek

Head of Management
Systems Certification
Department Brno

randysek@szutest.cz
+420 541 120 107
+420 602 584 954

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