ACCREDITATION TO CERTIFICATION OF MEDICAL EQUIPMENT
Below are links or references to documents for the specific scheme.
EXECUTIVE ORDERS
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 and inspection bodies
INTERNATIONAL INTERPRETATIONS
- IAF MD 1:2018. Certification of Multiple Sites Based on Sampling
- IAF MD 2:2017. Transfer of Accredited Certification of Management Systems
- IAF MD 4:2018. Use of information and comunication technology for audit and assessment
- IAF MD 5:2019 Determination of Audit Time of Quality, Environmental, and Occupational Health & Safety Management Systems
- IAF MD9:2022. Application of ISO/IEC 17021-1 in Medical Device Quality Management Systems (ISO 13485)
- IAF MD 23:2018. Control of Entities Operating on Behalf of Accredited Management Systems Certification Bodies
ACCREDITATION MESSAGES (IN DANISH)
AKKREDITERINGSMEDDELELSER - AMF
- AMF 05: Remote assessment for certification and inspection bodies
- AMF 06: Special provisions under COVID-19
AKKREDITERINGSMEDDELELSER - AMC
- AMC 04: Accreditation to certification of managements systems. Validity for certificates
- 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