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SRPS EN ISO 13485:2017

Статус: Објављен
Језик: Srpski
Бр. страна: 128
Датум: 30.11.2017.
Службени гласник:
Број решења: 3995/75-51-02/2017
Издање: 3
Веза са међународним стандардима
Ovaj standard je identičan sa:
EN ISO 13485:2016   CEN/CLC/JTC 3
Ovaj standard je identičan sa:
EN ISO 13485:2016/AC:2016   CEN/CLC/JTC 3
Ovaj standard je identičan sa:
ISO 13485:2016   ISO/TC 210
Цена: 6466 RSD

За читање онлајн

Одштампај

Наслов на српском језику

Medicinska sredstva – Sistemi menadžmenta kvalitetom – Zahtevi za svrhe propisa

Наслов на енглеском језику

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Апстракт на српском језику

Ovim međunarodnim standardom se utvrđuju zahtevi za sistem menadžmenta kvalitetom onda kada organizacija treba da pokaže svoju sposobnost da obezbeđuje medicinska sredstva i sa njima povezane usluge koje dosledno zadovoljavaju zahteve korisnika i primenljive zahteve propisa. Takve organizacije mogu da budu uključene u jednu ili više faza životnog ciklusa, uključujući projektovanje i razvoj, proizvodnju, skladištenje i distribuciju, postavljanje ili servisiranje medicinskog sredstva, kao i projektovanje i razvoj ili pružanje povezanih aktivnosti (npr. tehnička podrška). Ovaj međunarodni standard takođe mogu koristiti isporučioci ili eksterne strane koje obezbeđuju proizvod, uključujući usluge povezane sa sistemom menadžmenta kvalitetom koje pružaju takvim organizacijama.

Апстракт на енглеском језику

ISO 13485:2016 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization''s quality management system by monitoring, maintaining, and controlling the processes. If applicable 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 regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

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 Ознака стандарда
Језик
Статус
Датум
Бр. страна
Цена
 
Купи
Srpski
Повучен 
28.11.2014 . 
133 стр.
6466 RSD 
PDF
Medicinski uređaji - Sistemi menadžmenta kvalitetom - Zahtevi za svrhe regulative
Srpski
Повучен 
30.11.2017 . 
167 стр.
6857 RSD 
PDF
Medicinska sredstva — Sistemi menadžmenta kvalitetom — Zahtevi za svrhe regulative