Slide background
Slide background




Expert Commentary on BS EN ISO 13485:2016

ID 3179 | | Visite: 3128 | 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

DescrizioneLinguaDimensioneDownloads
Scarica questo file (ISO 13485 Expert Commentary BSI.pdf)ISO 13485 Expert Commentary BSI
BSI 2016
EN93 kB1155

Tags: Marcatura CE Direttiva Dispositivi medici

Ultimi archiviati Marcatura CE

Dangerous fakes
Gen 23, 2023 66

Dangerous fakes trade in counterfeit goods

Dangerous fakes trade in counterfeit goods that pose health, safety and environmental risks OECD/EUIPO (2022) - 9 March 2022 Illicit trade in counterfeit goods causes economic damage by reducing sales and profits as well as innovation incentives in legitimate industries. At the same time, some… Leggi tutto
Gen 13, 2023 184

Circolare INAIL n. 6821 del 13.10.2015

Circolare INAIL n. 6821 del 13.10.2015 Oggetto: Generatori di vapore ed acqua surriscaldata - Conduzione da personale abilitato patentino di abilitazione - possibilità esenzione EX DM 21/5/74 - Procedura di attuazione. Con riferimento all'oggetto si trasmette, per opportuna informativa:- ii parere… Leggi tutto
Gen 12, 2023 64

Raccolta E (ANCC)

Raccolta E (ANCC) / Gennaio 1979 Specificazioni tecniche applicative del D.M. 21 maggio 1974 - Norme integrative del regolamento approvato con R.D. 12 maggio 1927, n. 824, e disposizioni per l'esonero da alcune verifiche e prove stabilite per gli apparecchi a pressione.________ Visto l'art. 58 del… Leggi tutto
Gen 07, 2023 83

Istruzioni vigilanza articoli pirotecnici marcati CE e Modulo controllo Dogane

Istruzioni vigilanza articoli pirotecnici marcati CE e Modulo controllo Dogane Allegato modulo ad uso delle dogane e del personale addetto ai controlli per la vigilanza sul mercato. Controllo sulla marcatura ed etichettatura di un fuoco d'artificio - decreto legislativo 29 luglio 2015, n. 123;… Leggi tutto
Regolamento UE 2022 2480
Dic 19, 2022 159

Regolamento (UE) 2022/2480

Regolamento (UE) 2022/2480 / Modifica Regolamento sistema europeo di normazione ID 18405 | 19.12.2022 Regolamento (UE) 2022/2480 del Parlamento europeo e del Consiglio del 14 dicembre 2022 recante modifica del regolamento (UE) n. 1025/2012 per quanto riguarda le decisioni delle organizzazioni… Leggi tutto

Più letti Marcatura CE