Overview

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 9001:2000 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 9001:2000 unless their quality management systems conform to all the requirements of ISO 9001:2000. Due to the publication of the new European edition of DIN EN 13485:2012, it became necessary to publish this new edition of DIN EN ISO 13485, which contains the revised Annexes ZA to ZC and the modified European Foreword. Furthermore, the Technical Corrigendum EN ISO 13485:2012/AC submitted by CEN in July 2012 has been incorporated into this German version of EN ISO 13485:2012 which have been published as consolidated editions. The body of the standard containing the translation of ISO 13485:2003+A1:2009 has not been changed. The International Standard ISO 13485 has been prepared by Technical Committee ISO/TC 210 "Quality management and corresponding general aspects for medical devices" (secretariat: ANSI) in collaboration with Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices" (secretariat: NEN) with the collaboration of German experts. At DIN, the German Institute for Standardization e. V., the responsible committee was Working Committee NA 063-01-13 AA "Qualitätsmanagement und entsprechende allgemeine Aspekte für Medizinprodukte" ("Quality management and corresponding general aspects for medical devices") at the Medical Standards Committee.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices  

Responsible european committee

CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices