Telefon: (011) 7541-421, 3409-301, 3409-335, 6547-293, 3409-310
E-mail: Prodaja standarda: prodaja@iss.rs Seminari, obuke: iss-edukacija@iss.rs Informacije o standardima: infocentar@iss.rs
Stevana Brakusa 2, 11030 Beograd
Glavni meni

ISO 13485:2003

Medical devices — Quality management systems — Requirements for regulatory purposes
3. 7. 2003.
95.99 Povučen   24. 2. 2016.

Опште информације

95.99     24. 2. 2016.

ISO

ISO/TC 210

Međunarodni standard

03.100.70     11.040.01  

engleski   francuski   ruski  

Kupovina

Povučen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 13485:1996

TRENUTNO

POVUČEN
ISO 13485:2003
95.99 Povučen
24. 2. 2016.

ISPRAVKE / IZMENE

POVUČEN
ISO 13485:2003/Cor 1:2009

REVIDIRAN OD

OBJAVLJEN
ISO 13485:2016

Nacionalna preuzimanja

Medicinski uređaji - Sistemi menadžmenta kvalitetom - Zahtevi za svrhe regulative

95.99 Povučen