ACCREDITATION FOR MEDICAL EXAMINATION

Laboratories are accredited according to standard DS/EN ISO 15189 to carry out investigation of samples from the human body. This can be in the form of biological and microbiological testing, but also chemical, biophysical, pathological and other types of testing.

DS/EN ISO 15189, which is based on ISO/IEC 17025 and ISO 9001, contains requirements for competence and quality in the laboratory. These are requirements that apply specifically for medical laboratories.

POCT: Laboratories accredited to DS/EN/ISO 15189 can extent their accreditation to include DS/EN ISO 22870: 2006. Point of Care Testing (POCT) - Requirements for quality and competence. The requirements in DS/EN ISO 22870:2006 must be met when examinations are conducted using equipment under laboratory control, but by staff from other departments.

See also accreditation message M02 (AML M 02).

 

AREAS OF ACCREDITATION

  • Biochemistry
  • Microbiology
  • Immunology
  • Pathology
  • Medical imaging
  • Physiology and nuclear medicine
  • Genetics
  • Pharmacology
  • Sampling

 

RULES AND REGULATIONS:

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

 

EXECUTIVE ORDERS

 

ACCREDITATION STANDARD

  • DS/EN ISO 15189:2013. Medical laboratories - Requirements for quality and competence

Supplementary accreditation standard

  • DS/EN ISO 22870:2006. Point-of-care testing (POCT) – Requirements for quality and competence

 

ACCREDITATION REGULATIONS

 

GUIDELINES

In addition to the requirement documents listed above, the medical laboratory must comply with, a number of international guidelines are relevant for the accredited laboratories and implemented through the accreditation regulations.

 

INTERNATIONAL INTERPRETATIONS

International interpretations concerning the link between the accreditation of laboratories and fulfilment of ISO 9001.

 

ACCREDITATION MESSAGES

Various accreditation messages have also been published to guide and describe the assessment practice and relevant issues.

1. ACCREDITATION MESSAGES - AMF

 

2. AML M - FOR MEDICAL LABORATORIES

Application form

Contact person: Kirsten M. Rosenberg. Tel: +45 77 33 95 83. E-mail: kmr@danak.dk