Slide background
Slide background




Expert Commentary on BS EN ISO 13485:2016

ID 3179 | | Visite: 2000 | Documenti Marcatura CE ENTIPermalink: https://www.certifico.com/id/3179

Expert Commentary on BS EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes

The third edition of ISO 13485 was published on 1 March 2016 and has been adopted as EN ISO 13485:2016.

The European adoption has identical requirements in the body of the standard and the addition of a European Foreword and European Annexes ZA, ZB and ZC, which describe the relationship between the requirements of the three European Medical Devices Directives and the clauses of the standard. ISO 13485:2016 is a revision of the second edition of ISO 13485, which was published in 2003.

An updated European adoption of the second edition was published in 2012 with a revised European Foreword and new Annexes ZA, ZB and ZC. The third edition of the standard has been put forward to be harmonized against the Active Implantable Medical Devices Directive (AIMD) 90/385/EEC (as amended), the Medical Devices Directive (MDD) 93/42/EEC (as amended) and the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC, and has revised Annexes ZA, ZB and ZC with more detail, as compared with the Annexes Z for the 2012 version of EN ISO 13485, and changes to reflect the revised content of ISO 13485.

The structure of ISO 13485:2016 is aligned with ISO 9001:2008 and follows the clause and subclause sequence in ISO 9001:2008, but with some adjustment to the subclause numbering. This adjustment was introduced to accommodate the classification system for observations described by the Global Harmonization Task Force (GHTF) and used in the pilot Medical Devices Single Audit Programme (MDSAP), established by some members of the International Medical Devices Regulators Forum (IMDRF).

The GHTF was a precursor organization to the IMDRF. This classification system is numerical with a greater classification being applied to repeat or multiple observations in the same three-digit subclause (e.g. 4.2.1). In ISO 13485:2016, the subclause numbering has been amended to make the content at the three-digit level applicable to discrete aspects of the quality management system and reduce the breadth of content in some of the three-digit subclauses by reducing the occurrence of four- and five-digit subclause numbers. The structure of the revised ISO 13485 does not follow the structure of ISO 9001:20153 because:

1. the two standards were developed in parallel;

and

2. ISO 13485 is used for regulatory purposes and there was not alignment at this time with the regulatory authorities to introduce a major restructure to this standard.

However, Annex B has been included in the standard to provide cross-references with the clause structure in ISO 9001:2015 for organizations that wish to comply with both standards.

Read more

Pin It
Scarica questo file (ISO 13485 Expert Commentary BSI.pdf)ISO 13485 Expert Commentary BSIBSI 2016EN93 kB(364 Downloads)

Tags: Marcatura CE Direttiva Dispositivi medici

Articoli correlati

Ultimi archiviati Marcatura CE

FaQ   COVID 19 Verifica immissione sul mercato MD e DPI
Mag 28, 2020 144

Faq COVID-19 | Verifica immissione sul mercato MD e DPI

Faq - COVID-19 | Verifica immissione sul mercato MD e DPI EU, 25.05.2020 How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context The purpose of this guidance document is to provide basic… Leggi tutto
Decreto 13 febbraio 2020 n  72
Mag 21, 2020 86

Decreto 13 febbraio 2020 n. 72

Decreto 13 febbraio 2020 n. 72 Procedure di autorizzazione degli organismi di valutazione della conformita' e di controllo degli organismi notificati ai sensi del decreto del Presidente della Repubblica n. 239/2017, recante attuazione della direttiva 2014/90/UE sull'equipaggiamento marittimo.… Leggi tutto
Rapporto 28 2020
Mag 21, 2020 93

Dispositivi diagnostici in vitro per COVID-19

Dispositivi diagnostici in vitro per COVID-19 Rapporto ISS COVID-19 n. 28/2020 - Dispositivi diagnostici in vitro per COVID-19. Parte 1: normativa e tipologie. Versione del 18 maggio 2020 I dispositivi diagnostici in vitro (IVD) rappresentano strumenti essenziali per un’efficace gestione… Leggi tutto
Circolare Ministero della Salute del 05 Maggio 2020 n  26342
Mag 13, 2020 316

Circolare Ministero della Salute del 05 Maggio 2020 n. 26342

Circolare Ministero della Salute del 05 Maggio 2020 n. 26342 OGGETTO: Richieste di Autorizzazioni in deroga ai sensi dell’art. 11, comma 14 del D.Lgs. n. 46/97 ed Emergenza COVID 19 In merito alla possibilità di ricorrere ad autorizzazioni in deroga per la valutazione della conformità ai fini della… Leggi tutto

Più letti Marcatura CE

Giu 26, 2019 54041

Regolamento Prodotti da Costruzione (UE) 305/2011 - CPR

Regolamento CPR (UE) 305/2011 Regolamento (UE) N. 305/2011 del Parlamento Europeo e del Consiglio del 9 marzo 2011 che fissa condizioni armonizzate per la commercializzazione dei prodotti da costruzione e che abroga la direttiva 89/106/CEE del Consiglio (Testo rilevante ai fini del SEE) GU L 88/10… Leggi tutto