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Home > Publications > Promotional Documents > Brochure Contents > Introduction

IAF Brochure: (Download brochure in PDF format (2.2 Meg) View brochure as single page.

 

Brochure: The IAF Initiative for Accredited Certification to ISO 13485 -  Medical Devices

Introduction

ISO 13485 Medical Devices IAF Br IntroductionThe purpose of this brochure is to explain the benefits and use of the ISO 13485 Medical Device initiative developed by the International Accreditation Forum (IAF).

The initiative enables IAF accredited certification bodies to provide consistent, credible certification to ISO 13485.  The documents, developed as part of the IAF initiative, which are mandatory to both accreditation bodies within IAF and all certification bodies accredited by them to provide certification to ISO 13485, also enable national authorities with an opportunity to enhance their healthcare systems through the implementation of accredited ISO 13485 certification, without losing valuable access to medical devices that they are already using.

This brochure describes the importance of accredited certification and the roles and responsibilities of the different stakeholders with an interest in this scheme.  It explains the context within which ISO 13485 accredited certification is expected to be used and the links between this and medical device trade and public health.  

This informative guidance is intended to help the understanding of the utilisation of ISO 13485
accredited certification.

Objectives of the Initiative

  • Application of the initiative enables IAF accredited certification bodies to provide
    consistent, credible certification to ISO 13485.  
  • The initiative  documents, which are mandatory to both accreditation bodies within IAF and all  certification bodies accredited by them to provide certification to ISO 13485.
  • To enable national authorities with an opportunity to enhance their healthcare systems through the implementation of accredited ISO 13485 certification, without losing valuable access to   medical devices.

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Brochure Navigation:

IAF Br: IAF Reports associated with ISO 13485 (medical devices)IAF Br: IAF Reports associated with ISO 13485 (medical devices) Brochure Contents
Introduction to Accreditiation / Certification ISO 13485 Medical Devices 

Introduction

ISO 13485: Quality accredited in a national regulatory framework 

SO 13485 accredited certification within a national regulatory framework 

 ISO 13485 Medical Devices Br: Global Harmonization Task Force Relationship to guidance from the Global Harmonization Task Force (GHTF) 
IAF Br: How ISO 13485 certification relates to product certification  How ISO 13485 certification relates to product certification 
The IAF Multilateral Recognition Arrangement (MLA)
Structure of the MLA 
IAF Br: Risk Classification of Medical Devices to QMS requirements 

IAF MLA Mark
Key Features of the Initiative 

 IAF Br: IAF Reports associated with ISO 13485 (medical devices) Reports associated with the IAF Initiative 
Using Accredited ISO 13485 Certification in Practice 
 

 

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