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

Abstract

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.

DIN EN ISO 13485:2012-11 (E)
Medical devices – Quality management systems – Requirements for regulatory
purposes (ISO 13485:2003 + Cor. 1:2009) (in cludes Corrigendum :2012)
Contents Page
Page
Foreword ………………………………………………………………………………………………………………………………………….3
0 Introduction ………………………………………………………………………………………………………………………….5
0.1 General …………………………………………………………………………………………………………………………………5
0.2 Process approach …………………………………………………………………………………………………………………5
0.3 Relationship with other standards 5
0.4 Compatibility with other management systems ……………………………………………………………………..6
1 Scope …………………………………………………………………………………………………………………………………..6
1.1 General …………………………………………………………………………………………………………………………………6
1.2 Application …………………………………………………………………………………………………………………………..6
2 Normative references ……………………………………………………………………………………………………………7
3 Terms and definitions …………………………………………………………………………………………………………..7
4 Quality management system …………………………………………………………………………………………………9
4.1 General requirements ……………………………………………………………………………………………………………9
4.2 Documentation requirements ………………………………………………………………………………………………..9
5 Management responsibility ……………………………………………………………………………………………….. 11
5.1 Management commitment …………………………………………………………………………………………………. 11
5.2 Customer focus …………………………………………………………………………………………………………………. 11
5.3 Quality policy ……………………………………………………………………………………………………………………. 11
5.4 Planning ……………………………………………………………………………………………………………………………. 12
5.5 Responsibility, authority and communication …………………………………………………………………….. 12
5.6 Management review …………………………………………………………………………………………………………… 13
6 Resource management ……………………………………………………………………………………………………… 13
6.1 Provision of resources ………………………………………………………………………………………………………. 13
6.2 Human resources ………………………………………………………………………………………………………………. 14
6.3 Infrastructure …………………………………………………………………………………………………………………….. 14
6.4 Work environment …………………………………………………………………………………………………………….. 14
7 Product realization ……………………………………………………………………………………………………………. 15
7.1 Planning of product realization ………………………………………………………………………………………….. 15
7.2 Customer-related processes ……………………………………………………………………………………………… 15
7.3 Design and development …………………………………………………………………………………………………… 16
7.4 Purchasing ……………………………………………………………………………………………………………………….. 18
7.5 Production and service provision ………………………………………………………………………………………. 19
7.6 Control of monitoring and measuring devices ……………………………………………………………………. 22
8 Measurement, analysis and improvement ………………………………………………………………………….. 22
8.1 General ……………………………………………………………………………………………………………………………… 22
8.2 Monitoring and measurement ……………………………………………………………………………………………. 23
8.3 Control of nonconforming product …………………………………………………………………………………….. 24
8.4 Analysis of data ………………………………………………………………………………………………………………… 24
8.5 Improvement …………………………………………………………………………………………………………………….. 25
Annex A (informative) Correspondence between ISO 13485:2003 and ISO 13485:1996 ……………………. 26
Annex B (informative) Explanation of differences between ISO 13485:2003 and ISO 9001:2000 ……….. 30

Annex ZA (informative) Relationship between this European Standard and the Conformity
Assessment Requirements of EU Directive 90/385/EEC ………………………………………………………..62
Annex ZB (informative) Relationship between this European Standard and the Conformity
Assessment Requirements of EU Directive 93/42/EEC ………………………………………………………… 67
Annex ZC (informative) Relationship between this European Standard and the Conformity
Assessment Requirements of EU Directive 98/79/EC …………………………………………………………… 74

Bibliography …………………………………………………………………………………………………………………………………. 81

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

DIN EN 14136:2004-08 (D)
Verwendung externer Qualitätssicherungsprogramme bei der Bewertung der
Durchführung von Untersuchungsverfahren in der In-vitro-Diagnostik; Deutsche
Fassung EN 14136:2004
Inhalt Seite
Vorwort……………………………………………………………………………………………………………………………………………. 3
Einleitung ………………………………………………………………………………………………………………………………………… 3
1 Anwendungsbereich…………………………………………………………………………………………………………….. 4
2 Normative Verweisungen ……………………………………………………………………………………………………… 5
3 Begriffe………………………………………………………………………………………………………………………………… 5
4 Gestaltungsanforderungen für externe Qualitätssicherungsprogramme (EQAS)……………………. 6
5 Anforderungen an Organisationen, die EQAS durchführen……………………………………………………. 7
6 Bewertung analytischer Untersuchungsverfahren…………………………………………………………………. 8
6.1 Allgemeines …………………………………………………………………………………………………………………………. 8
6.2 Bewertungsverfahren für quantitative Ergebnisse auf Verhältnis- oder Differenzskalen…………. 9
6.3 Beurteilung qualitativer Ergebnisse auf Nominalskalen oder quantitativer Ergebnisse auf
Ordinalskalen……………………………………………………………………………………………………………………….. 9
7 Verwendung der Ergebnisse zur Feststellung möglicher Mängel…………………………………………. 10
8 Archivierung der Dokumente………………………………………………………………………………………………. 10
9 Vertraulichkeit ……………………………………………………………………………………………………………………. 10
Anhang ZA (informativ) Zusammenhang zwischen dieser Europäischen Norm und den
grundlegenden Anforderungen der EU-Richtlinie 98/79/EG………………………………………………….. 11
Literaturhinweise……………………………………………………………………………………………………………………………. 12