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

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

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

AB 1: General regulation for accreditation of companies
AB 2: DANAK's accreditation mark and reference to accreditation
AB 3: Accreditation of laboratories
AB 10: Accreditation of laboratories to a flexible scope of accreditation

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.

EA-4/14:2003: The Selection and Use of Reference Materials
EA-4/18:2021: Guidance on the level and frequency of proficiency testing participation
ILAC G8:09/2019: Guidelines on Decision Rules and Statements of Conformity
ILAC G17:01/2021: ILAC Guidelines for Measurement Uncertainty in Testing
ILAC G19:06/2022: Modules in a Forensic Science Process
ILAC G24:2022: Guidelines for the determination of recalibration intervals of measuring equipment

ACCREDITATION MESSAGES

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