Да ли су вам стандарди потребни у вашем послу?
Да
Не
Понекад
Не знам
Укупан број гласова: 7167

Пријавите се!
 

SRPS EN ISO 13485:2008

Статус: Повучен
Језик: Srpski
Бр. страна: 133
Датум: 09.10.2008.
Датум повлачења: 28.11.2014 .
Службени гласник: 104/8
Број решења:
Издање: 1 ED
Веза са међународним стандардима
Ovaj standard je identičan sa:
EN ISO 13485:2003   CEN/CLC/JTC 3
Цена: 6466 RSD

За читање онлајн

Одштампај

Наслов на српском језику

Medicinski uređaji - Sistemi menadžmenta kvalitetom - Zahtevi za svrhe regulative

Наслов на енглеском језику

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

Апстракт на српском језику

Ovaj međunarodni standard specificira zahteve za sistem menadžmenta kvalitetom, koje organizacija može koristiti za projektovanje i razvoj, proizvodnju i servisiranje medicinskih uređaja, kao i za pružanje odgovarajućih usluga. Mogu se takođe koristiti i sve interne i eksterne zainteresovane strane, uključujući i sertifikaciona tela, za ocenu sposobnosti organizacije da ispunjava zahteve korisnika i zahteve propisa.

Апстракт на енглеском језику

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.

Комисија за стандарде


ICS



Директиве



Национални пропис



Национална активност



Дескриптори

menadžment;medicinski;uređaj;sistemi;kompatibilnost;zahtev;politika;korisnik; preispitivanje;upravljanje;merenje;neusaglašen;proizvod


Извор

 Ознака стандарда
Језик
Статус
Датум
Бр. страна
Цена
 
Купи
Srpski
Повучен 
30.11.2017 . 
167 стр.
6857 RSD 
PDF
Medicinska sredstva — Sistemi menadžmenta kvalitetom — Zahtevi za svrhe regulative