ACCREDITATION TO CERTIFICATION OF MEDICAL EQUIPMENT

Below are links or references to documents for the specific scheme.

EXECUTIVE ORDERS

• Executive order No. 913 of 25 September 2009 on accreditation of companies
  
  

ACCREDITATION STANDARD

• DS/EN ISO/IEC 17021-1:2015, ’Conformity assessment – Requirements for bodies providing audit and certification of management systems - Part 1: Requirements’ 4th edition 2015-07-30
• ISO/IEC 17021-3:2016, 'Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 3: competence requirements for auditing and certification of quality management systems 1st edition 2016-06-29
  
  

ACCREDITATION REGULATIONS

• AB 1 General regulation for accreditation of companies
• AB 2 DANAK’s accreditation mark and reference to accreditation
• AB 6 Accreditation to certification
• AB 18: Accreditation as basis for notification
  
• AB 20: Flexible accreditation scope for certification, inspection, validation and verification bodies
  
  

INTERNATIONAL INTERPRETATIONS

• IAF MD 1:2023 IAF Mandatory Document for the Audit and Certification of a Management System Operated by a Multi-Site Organization
• IAF MD 2:2023 IAF Mandatory Document for the Transfer of Accredited Certification of Management Systems
• IAF MD 4:2023 IAF Use of Information and Communication Technology (ICT) for Auditing/Assessment Purposes
• IAF MD 5:2023 Determination of Audit Time of Quality, Environmental, and Occupational Health & Safety Management Systems
• IAF MD 9:2023 Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)

• IAF MD23:2023 Control of Entities Operating on Behalf of Accredited Management Systems Certification Bodies

ACCREDITATIONS MESSAGES - IN DANISH

AKKREDITERINGSMEDDELELSER - AMF

• AMF 04: Management of Non-compliances
• AMF 05: Remote assessment for certification and inspection bodies

AKKREDITERINGSMEDDELELSER - AMC

• AMC 15: Accreditation to certification of management systems, persons and verification. Information on the extent of DANAK's witness activities
• AMC 29: Requirements for accreditation for certification to ISO 13485 - Implementation of IAF MD 8 and 9:2017
• AMC 35: Accreditation announcement on multisite requirements
• AMC 36:Indication of additional requirements in management systems certificates
• AMC 40: Implementation of second delimitation of accreditation area for Management Systems - QMS, EMS, OH & SMS and EnMS
• AMC 43: Accreditation regarding scope of audit for certification of management systems
• AMC 45: Certification of Management Systems - Reporting to IAF CertSearch