Hivatkozási szám

MSZ EN ISO 13485:2016

Dokumentumazonosító

663676

Cím

Orvostechnikai eszközök. Minőségirányítási rendszerek. Szabályozási célú követelmények (ISO 13485:2016)

Angol cím

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

Alkalmazási terület

This International Standard 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). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Requirements of this International Standard 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 this International Standard 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 this International Standard reflect any exclusion of design and development controls. If any requirement in Clauses 6, 7 or 8 of this International Standard 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.

ICS

03.100.70 Irányítási rendszerek

11.040.01 Orvostechnikai berendezések általában

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2016-09-01

Forrás

idt ISO 13485:2016; idt EN ISO 13485:2016/AC:2018; idt EN ISO 13485:2016/AC:2016; idt EN ISO 13485:2016

Előd

MSZ EN ISO 13485:2012

Utód

Módosítás

MSZ EN ISO 13485:2016/A11:2022

Kiegészítő információk

SZK-közlemények

2019/05: Helyesbítés

Kapcsolódó európai jogszabály

98/79/EK AZ EURÓPAI PARLAMENT ÉS A TANÁCS 98/79/EK IRÁNYELVE (1998. október 27.) az in vitro diagnosztikai orvostechnikai eszközökről (VITD); 93/42/EGK A TANÁCS 93/42/EGK IRÁNYELVE (1993. június 14.) az orvostechnikai eszközökről (MDV93); 90/385/EGK A TANÁCS IRÁNYELVE (1990. június 20.) az aktív beültethető orvostechnikai eszközökre vonatkozó tagállami jogszabályok közelítéséről (90/385/EGK) (IMD90)

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