Accreditation of Laboratories - Health Care
Below can be found references or links to general and specific documents which are DANAK´s basis for accreditation.
Such documents are translations from Danish. Any differences between the Danish and the English versions are not intended but in case of doubt with respect to the correctness of the English translation, the Danish language version should be consulted. Danish versions can be found here.
Rules and regulations
- DANAK's fees for accreditation 2009
- The Statutory Order No. 745, dated September 27, 1999 (laboratory accreditation)
Standards
(to be purchased at the Danish Standards Assosiation (DS))- DS/EN ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
- DS/EN ISO 15189:2008 Medical laboratories - Particular requirements for quality and competence
Joint ISO-ILAC-IAF Communiques
Technical regulations -TF
- TF 1 DANAK’s accreditation mark and reference to accreditation
- TF 2 Granting and Maintaining Accreditation
- TF 4 Rules concerning the obligation to provide information
- TF 5 Approved Calibration Certificates
Guidelines - RL
- RL 1 Validation of methods in chemical analytical laboratories – quantitative methods of analysis
- RL 2 Flexible scope of accreditation for testing laboratories
- RL 3 Description of accreditation areas for laboratories
- RL 4 Text of information on accreditation and the use of calibration labels at calibration laboratories
- RL 5 Activities performed on site
- RL 6 Validation of measurement procedurers (methods validation) in clinical biochemical laboratories
- RL 9 Proficiency Testing and Comparative Testing. All types of accreditations
- RL 11 DANAK’s policy for measurement uncertainty at calibration and testing
- RL 12 Entitled to sign
EA guidelines on EA's homepage
ILAC - Guidelines from ILAC-homepage
- G-13:2007. ILAC Guidelines for the Requirements for the Competence of Providers of Proficiency Testing Schemes
- G-17:2002. Introducing the Concept of Uncertainty of Measurement in Testing in Association with the Application of the Standard ISO/IEC 17025
- G-24:2007. ILAC Guidelines for the determination of calibration intervals of measuring instruments
EURACHEM - Guidelines from EURACHEM-homepage
Accreditation messages - AML
- AML 01 of 2007.11.30. Declarations of validaty of medical examinations within the clinical bio chemical speciality
- AML 03 of 2007.11.30. Use of computer systems in accredited laboratories
- AML 04 of 2010.02.11. Processes and tools for handling non-compliances
- AML 06 of 2008.10.08. Accreditation to Point-of-care testing – Requirements to quality and kompetence
- AML 07 of 2008.10.08. Securing independence and impartiality
- AML 10 of 2008.10.08. Surveillance of superior common management system for more accreditations
- AML 11 of 2008.10.08. Reports from laboratories authorized to verification within legal metrology
- AML 12 of 2008.10.08. Liberty of action of Medical Laboratories without flexible scope