ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes 
ISO/TR 14969:2004  Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003

ISO 13485:2003     
Medical devices -- Quality management systems -- Requirements for regulatory purposes
 
Edition:  2 (Monolingual)
Number of pages:  57
Technical committee / subcommittee:  TC 210; ISO Standards
ICS:  11.040.01; 03.120.10
Status:   Published standard
Current stage:  60.60
Stage date:  2003-07-03
Revision information: (Show)  
 

Abstract

 ISO 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.
 
 
 
 ISO/TR 14969:2004 Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003

Edition:  1 (Monolingual)
Number of pages:  74
Technical committee / subcommittee:  TC 210; ISO Standards
ICS:  11.040.01; 03.120.10
Status:   Published standard
Current stage:  60.60
Stage date:  2004-10-18
Revision information: (Show)  
 
Abstract

ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.

This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.