SIST EN ISO 13485:2016/AC:2017

Oznaka standarda: SIST EN ISO 13485:2016/AC:2017
Koda projekta: JT003C07
Organizacija: SIST
Naslov (angleški): Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Naslov (slovenski): Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2016)
Če kupite standardizacijski dokument v .pdf formatu prek spletne prodaje, vam nudimo 20% popust pri spodnji ceni brez DDV. Cenik SIST
Dokumenti
Ime Jezik Status Cena Dodaj v košarico
SIST EN ISO 13485:2016/AC:2017 angleški jezik Withdrawn SIST-AC: 0.00 EUR
PDF
Papir
SIST EN ISO 13485:2016/AC:2017 slovenski jezik Withdrawn SIST-AC: 0.00 EUR
PDF
Papir
Tehnični odbor: VAZ - Varovanje zdravja
ICS: 03.100.70 11.020.01
Status: Razveljavljen
Objavljen: 01-apr-2017
Refer. št. objave: Sporocila 2017-04
Razveljavitev: 01-maj-2018
Referenca razveljavitve: Sporocila 2018-05
Področje projekta (angleško): 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.
Povezava na standarde
Povezava Ime Datum
Popravek k SIST EN ISO 13485:2016 - Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2016) 01-mar-2017
Nadomeščen z SIST EN ISO 13485:2016/AC:2018 - Medicinski pripomočki - Sistemi vodenja kakovosti - Zahteve za zakonodajne namene (ISO 13485:2016) - Popravek AC 01-maj-2018


• Slovenski standardi SIST s cenovnim razredom AC so popravki standardov in so v večini primerov brezplačni.

• Slovenski standardi SIST s cenovnim razredom AP so privzeti tuji standardi, katerih sestavni del je izvirni standard, ki ga moramo pridobiti pri izdajatelju v tujini. Naročilo pošljite na: prodaja@sist.si.

Najbolje prodajani standardi