DIN EN ISO 13485:2007
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007

Standard No.

DIN EN ISO 13485:2007

Release Date

2007

Published By

German Institute for Standardization

Status

Withdraw 2010-01

Replace By

DIN EN ISO 13485:2010

Latest

DIN EN ISO 13485:2021

DIN EN ISO 13485/A1:2019

DIN EN ISO 13485:2016

DIN EN ISO 13485:2021-12

DIN EN ISO 13485 E:2014-04

DIN EN ISO 13485:2012

DIN EN ISO 13485:2010

Scope

1.1 General 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 requirements and regulatory requirements applicable to medical devices and related services. The primary objective of this International Standard 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 ali the requirements of ISO 9001 (see Annex B). 1.2 Application All requirements of this International Standard 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 (see 7.3), 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 this International Standard reflect exclusion of design and development controls [see 4.2.2 a) and 7.3]. If any requirement(s) in Clause 7 of this International Standard 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 [see 4.2.2 a)]. The processes required by this International Standard, 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 [see 4.1 a)]. In this International Standard the terms "if appropriate' and "where appropriate ~ are used several times. When a requirement is qualified by either of these phrases, it is deemed to be "appropriate" unless the organization can document a justification otherwise. A requirement is considered "appropriate' if it is necessary in order for -- the product to meet specified requirements, and/or -- the organization to carry out corrective action.

DIN EN ISO 13485:2007 history

• 2021 DIN EN ISO 13485:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
• 2019 DIN EN ISO 13485/A1:2019 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
• 2017 DIN EN ISO 13485 Berichtigung 1:2017 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016, Corrigendum to DIN EN ISO 13485:2016-08; German version EN ISO 13485:2016/AC:2016
• 2016 DIN EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016
• 2012 DIN EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012
• 2010 DIN EN ISO 13485:2010 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009
• 2007 DIN EN ISO 13485:2007 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007
• 2003 DIN EN ISO 13485:2003 Medical devices quality management systems requirements for regulatory purposes
• 2001 DIN EN ISO 13485:2001 Quality assurance systems for medical devices