Slide background
Slide background

Expert Commentary on BS EN ISO 13485:2016

ID 3179 | | Visite: 1279 | 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

Scarica questo file (ISO 13485 Expert Commentary BSI.pdf)ISO 13485 Expert Commentary BSIBSI 2016EN93 kB(244 Downloads)

Tags: Marcatura CE Direttiva Dispositivi medici

Articoli correlati

Ultimi archiviati Marcatura CE

Ott 12, 2018 23

RAPEX Report 41 del 12/10/2018 N. 9 A12/1486/18 Bulgaria

RAPEX: Rapid Alert System for Non-Food Consumer Products Report 41 del 12/10/2018 N. 9 A12/1486/18 Bulgaria Approfondimento tecnico: Candela Il prodotto, di marca Maisen, è stato sottoposto alla procedura di ritiro dal mercato perché non conforme alla norma tecnica Europea EN 15493:2008 - Candele -… Leggi tutto
Ott 05, 2018 39

RAPEX Report 40 del 05/10/2018 N. 16 A12/1440/18 Finlandia

RAPEX: Rapid Alert System for Non-Food Consumer Products Report 40 del 05/10/2018 N. 16 A12/1440/18 Finlandia Approfondimento tecnico: Spaccalegna Il prodotto, di marca Timco Tools, mod. WP-7N è stato sottoposto alla procedura di richiamo presso i consumatori perché non conforme alla Direttiva… Leggi tutto
Set 28, 2018 49

RAPEX Report 39 del 28/09/2018 N.14 A12/1419/18 Francia

RAPEX: Rapid Alert System for Non-Food Consumer Products Report 39 del 28/09/2018 N. 14 A12/1419/18 Francia Approfondimento tecnico: Hoverboard Il prodotto, di marca REVOE, è stato sottoposto alla procedura di richiamo presso gli utilizzatori perché non conforme alla Direttiva 2006/42/CE del… Leggi tutto
Technical File Medical Device
Set 27, 2018 106

Technical File Medical Device

Technical File Medical Device Il presene documento si propone dare informazioni relative al Regolamento (UE) 2017/745 per la costituzione di un Technical File Medical Device.Questa prima Revisione 00 2019 è puramente normativa, con revisioni successive daremo esempi pratici. Regolamento (UE)… Leggi tutto
Set 21, 2018 65

RAPEX Report 38 del 21/09/2018 N. 1 A12/1375/18 Francia

RAPEX: Rapid Alert System for Non-Food Consumer Products Report 38 del 21/09/2018 N. 1 A12/1375/18 Francia Approfondimento tecnico: Trappola per insetti Il prodotto, di marca Aries, è stato sottoposto alla procedura di richiamo presso i consumatori perché non conforme al Regolamento (CE) N.… Leggi tutto
Set 14, 2018 77

RAPEX Report 37 del 14/09/2018 N. 36 A11/0067/18 Polonia

RAPEX: Rapid Alert System for Non-Food Consumer Products Report 37 del 14/09/2018 N. 36 A11/0067/18 Polonia Approfondimento tecnico: Gilet ad alta visibilità Il prodotto, di marca sconosciuta, mod. WX-B1001, è stato sottoposto alla procedura di ritiro dal mercato perché non conforme Direttiva… Leggi tutto

Più letti Marcatura CE

Ott 01, 2017 33646

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) G.U.U.E L… Leggi tutto