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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

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

Guidelines - RL

EA guidelines on EA's homepage

ILAC - Guidelines from ILAC-homepage

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
 

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