SIST EN ISO 13485:2003/AC:2009

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

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).

Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003/Cor 1:2009)

Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003/Cor 1:2009)

Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2003/Cor 1:2009)

General Information

• Status: Withdrawn
• Publication Date: 17-Nov-2009
• Withdrawal Date: 12-Mar-2012
• ICS: 03.100.70 - Management systems
• ICS: 11.020.01 - Quality and environmental management in health care
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 13-Mar-2012
• Due Date: 05-Apr-2012
• Completion Date: 13-Mar-2012
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Ref Project: EN ISO 13485:2003/AC:2009 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)

Relations

• Replaces: SIST EN ISO 13485:2003/AC:2008 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
• Effective Date: 27-Jun-2009
• Replaced By: SIST EN ISO 13485:2012 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
• Effective Date: 01-Apr-2012
• Replaces: SIST EN ISO 13485:2003/AC:2008 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
• Effective Date: 08-Jun-2022
• Corrects: SIST EN ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.NRQRGDMQHMedizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke
(ISO 13485:2003/Cor 1:2009)Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003/Cor 1:2009)Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)11.040.01Medicinska oprema na splošnoMedical equipment in general03.120.10Vodenje in zagotavljanje kakovostiQuality management and quality assuranceICS:Ta slovenski standard je istoveten z:EN ISO 13485:2003/AC:2009SIST EN ISO 13485:2003/AC:2009en,fr,de01-december-2009SIST EN ISO 13485:2003/AC:2009SLOVENSKI
STANDARDSIST EN ISO 13485:2003/AC:20081DGRPHãþD



SIST EN ISO 13485:2003/AC:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 13485:2003/AC
August 2009
Août 2009
August 2009 ICS 03.120.10; 11.040.01 English version Version Française Deutsche Fassung
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003/Cor 1:2009)
Dispositifs médicaux - Systèmes de manegement de la qualité - Exigences à des fins réglementaires (ISO 13485:2003/Cor 1:2009)
Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke
(ISO 13485:2003/Cor 1:2009) This corrigendum becomes effective on 26 August 2009 for incorporation in the three official language versions of the EN.
Ce corrigendum prendra effet le 26 août 2009 pour incorporation dans les trois versions linguistiques officielles de la EN.
Die Berichtigung tritt am 26. August 2009 zur Einarbeitung in die drei offiziellen Sprachfassungen der EN in Kraft. CEN Management Centre: CENELEC Central Secretariat:Avenue Marnix 17, B-1000 Brüssel Avenue Marnix 17, B-1000 Brüssel© 2009 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier aux membres nationaux du CEN et aux membres du CENELEC. Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedern von CEN und den Mitgliedern von CENELEC vorbehalten. Ref. No. EN ISO 13485:2003/AC:2009 D/E/F SIST EN ISO 13485:2003/AC:2009



EN ISO 13485:2003/AC:2009 (E) 2 Modifications following EN ISO 13485:2003/AC:2007 1 Modification to the title page Add the following reference to the superseding note: “EN 46003:1999” 2 Modification to the 2nd paragraph Replace with the following: "This European Standard supersedes EN 46003:1999, EN ISO 13485:2000 and EN ISO 13488:2000." 3 Modification to the 3rd paragraph Replace "July 2006" with" July 2009" 4 Modification to the 7th paragraph Replace the first sentence with the following: "Three of the modules cited in Council decision, i.e. modules E, D and H require that "the manufacturer must operate an approved quality system". Add the following first dash to the existing two: "- Final product inspection and testing (module E)," 5 Modification to the 8th paragraph Replace twice in the first and second sentences "modules D or H" with "modules E, D or H". 6 Modification to the 9th paragraph To be deleted. 7 Modification to the table Replace the table with the following:
Module D Permissible exclusions Module E Permissible exclusions for conformity of "product quality assurance" Module H Permissible exclusions SIST EN ISO 13485:2003/AC:2009



EN ISO 13485:2003/AC:2009 (E) 3 Sub-clause 7.3: design and development Sub-clause 7.3: design and development Sub-clause 7.5.1: control of production and service provision Sub-clause 7.5.2: validation of processes for production and service provision NO exclusions permitted Module D is the basis for annex V of 93/42/EEC Directive and the basis for annex VII of 98/79/EC Directive. Module E is the basis for annex VI of Directive 93/42/EEC. Module H is the basis for annex 2 of Directive 90/385/EEC, for annex II of Directive 93/42/EEC and for annex IV of Directive 98/79/EC.
8 Modification to the endorsement notice Delete the note. 9 Modification to Annex ZA Replace Annex ZA with the following:
"Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Associati
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