International Standards and Conformity Assessment for all electrical, electronic and related technologies

CEN/CLC/TC 3

Quality management and corresponding general aspects for medical devices

 

Project

Reference EN ISO 13485:2012/AC:2012
Title Medical devices - Quality management systems - Requirements for regulatory purposes
Project Number 24183
Abstract/Scope SO 13485:2003 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 ISO 13485:2003 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. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls. If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system. The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.
Status
Published

Status

Current Stage code 6060
Current Stage code date 2012-07-06
Current Stage code deadline  
Deadline date for vote  

Legal

Directive(s)  
Mandate(s)  
Order Voucher  

Details

IEC Technical Body IEC/SC 62A
Reference Document  
ICS  
Keywords  
Note  
A-Deviation(s)  
Special National Condition(s)  

Environment

Clause
Categories - Aspects
Product Life Cycle
Information

History

Stage
Date
Deadline Date
Documents
6060 2012-07-06   export to doc file  EN  FR  DE
1099 2012-04-27    

Implementation Dates

date of Ratification (DOR) (1)  
date of Availability (DAV) (2) 2012-07-06
date of Announcement (DOA) (3) -
date of Publication (DOP) (4) -
date of Withdrawal (DOW) (5) -

Relations

Supersedes  
Superseded by prEN ISO 13485:2014
Normative reference (6)  

(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved


(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat


(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level


(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement


(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn


(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.