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.
AREAS OF ACCREDITATION
- Biochemistry
- Pharmacology
- Physiology and Nuclear Medicine
- Genetics
- Immunology
- Microbiology
- Pathology
- Special laboratory
EXECUTIVE ORDERS
ACCREDITATION STANDARD
- DS/EN ISO 15189:2022. Medical laboratories - 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
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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.
AML - FOR ALL TYPES OF LABORATORIES
- AML 02: Extend of accreditation scope
- AML 03: Use of computer systems in accredited laboratories.
- AML 07: Securing independence and impartiality.
- AML 10: Surveillance of the general management system of multiple accreditations.
- AML 17: Internal audit and management evaluation.
- AML 18: Formulation of scope of accreditation.
- AML 22: Submitting electronic management systems.
- AML 23: Reference to DANAK and accreditation and specification of traceability.
- AML 28: Calibration and control of measuring equipment
- AML 29: Change of location
AML M - FOR MEDICAL LABORATORIES
- AML M01: Declarations of validity in medical examinations in clinical biochemistry
- AML M02: Accreditation to Point-of-care testing – Requirements to quality and competence
- AML M03: Use of referral laboratories
- AML M05: Change of equipment in medical laboratories
- AML M06:Verification of examination results' reproduction in external information systems
- AML M07: Genetic analyzes and studies
- AML M08: Implementation and transition period for ISO 15189:2022
- AML M09: Specification of accreditation scope for pathology laboratories
- AML M10: Evaluation of ECG
- AML M11: Field of Diagnostics
ACCREDITATION MESSAGES - AMF
- AMF 04: Management of Non-compliances