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
- 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-4/18:2010: 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 G19:08/2014: Modules in a Forensic Science Process
- ILAC G-24:2007: ILAC Guidelines for the determination of calibration intervals of measuring instruments
ACCREDITATION MESSAGES
Various accreditation messages have also been published to guide and describe the assessment practice and relevant issues.
1. ACCREDITATION MESSAGES - AMF
3. AML - FOR ALL TYPES OF LABORATORIES
- AML 02: Extend of accreditation scope
- AML 03: Use of computer systems in accredited laboratories.
- AML 04: Processing non-conformities.
- 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
2. AML M - FOR MEDICAL LABORATORIES
- AML M 01: Declarations of validity in medical examinations in clinical biochemistry
- AML M 02: Accreditation to Point-of-care testing – Requirements to quality and competence
- AML M 03: Use of referral laboratories
- AML M 05: Change of equipment in medical laboratories
- AML M 06:Verification of examination results' reproduction in external information systems
- AML M 07: Genetic analyzes and studies
- AML M08: Implementation and transition period for ISO 15189:2022