Swedac accredits medical laboratories. Through accreditation, it is ensured that the samples submitted are handled and analyzed consistently, regardless of the laboratory’s location in the country, whether it is large or small, private or public. The accreditation signifies that laboratory work is performed impartially and correct, based on internationally recognized standards.
EN ISO 15189 sets requirements for quality and competence in medical laboratories. The medical laboratory is crucial for patient care, as decisions regarding patient treatment are made based on laboratory results. The standard is designed to ensure the high quality of laboratory tests and to promote confidence in the results produced by medical laboratories.
EN ISO 15189 provides a framework that enables medical laboratories to consistently develop their quality management systems and assess their own competence.
Requirements and guidance documents - Medical testing
Requirements to be Met for Accreditation to be Granted:
- SS-EN ISO 15189:2022 | Medical Laboratories – Requirements for Quality and Competence
- STAFS 2020:1 | Swedac’s Regulations and General Guidelines on Accreditation
Instructions and Guidelines for Meeting Accreditation Requirements:
- EA-4/02 M:2022 | Evaluation of the Uncertainty of Measurement in Calibration
- EA-4/17 M:2022 | Description of Scopes of Accreditation for Medical Laboratories
- EA-4/18 G:2021 | Guidance on the Level and Frequency of Proficiency Testing Participation
- EA-4/21 INF:2018 | Guidelines for the Assessment of the Appropriateness of Small Interlaboratory Comparisons within the Process of Laboratory Accreditation
- ILAC G17:01/2021 | ILAC Guidelines for Measurement Uncertainty in Testing
- ILAC G24:2022 | Guidelines for the Determination of Recalibration Intervals of Measuring Equipment
- ILAC G26:11:2018 | Guidance for the Implementation of a Medical Accreditation Scheme
- ILAC G8:09/2019 | Guidelines on Decision Rules and Statement of Conformity
- SWEDAC DOC 01:14 | Assessment of Quality Systems in an Electronic Environment
- SWEDAC DOC 03:9 | Swedac’s Policy on Flexible Scope Accreditation
- SWEDAC DOC 04:2 | Swedac’s Policy for Metrological Traceability, Calibration, and Measurement Uncertainty
- SWEDAC DOC 05:3 | Measurement Uncertainty in Laboratory Medicine and Imaging and Functional Medicine
- SWEDAC DOC 05:6 | Internal Audits – Guidance for Laboratories and Inspection Bodies
- SWEDAC DOC 06:9 | Swedac’s Policy for the Participation of Accredited Laboratories and Inspection Bodies in Proficiency Testing
- SWEDAC DOC 10:5 | Guidance for Information Security Work
- SWEDAC DOC 12:7 | Guidance on the Use of Scales in Testing Laboratories and Inspection Bodies
- SWEDAC DOC 20:1 | Swedac’s Policy for Referencing Accreditation