NEN-EN-ISO 13485:2012 en

Withdrawn standard
57 Pages
Publication date 2012-02-01
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Medical devices - Quality management systems - Requirements for regulatory purposes
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001 (see Annex B).
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Registration date
ICS code
03.100.70 Management Systems * 11.040.01 Medical Equipment In General
Related to
ISO 13485:2003 en, IDT * EN ISO 13485:2012, IDT
Health services - Quality - Quality assurance systems - Quality management - Medical equipment

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