Medical Diagnostics
For the accreditation of medical laboratories, the standard SS-EN ISO 15189 applies. This standard comprises eight chapters and addresses requirements for management systems such as organization, document control, and customer communication, as well as technical requirements like personnel competence, method selection, and equipment. SS-EN ISO 15189 is specifically aimed at medical laboratories and includes explicit requirements for pre-analysis and collaboration with clinics. Another requirement for accreditation is participation in proficiency testing. Accreditation is also conducted according to Swedac’s own regulations, STAFS.
For the accreditation of clinical patient-related activities and activities not related to medical diagnostics, the standard for testing laboratories, SS-EN ISO/IEC 17025, applies.
For the accreditation of autopsy services, the standard for inspection bodies, SS-EN ISO/IEC 17020, applies.
Swedac accredits laboratories in the following areas:
- Clinical Genetics
- Clinical Pharmacology
- Clinical Chemistry
- Clinical Microbiology
- Clinical Pathology
- Clinical Immunology and Transfusion Medicine
- Imaging and Functional Medicine (e.g., Radiology and Clinical Physiology)
- Non-Clinical Genetics
- Clinical Autopsy
Other related activities accredited according to SS-EN ISO/IEC 17025 include medical research, forensic science, and veterinary medicine. Such accreditation is addressed here.
Other related activities accredited according to SS-EN ISO/IEC 17020 include forensic autopsy. Such accreditation is addressed here.
Guidelines (Swedac DOC) for accreditation have been developed in collaboration with specialist associations for each area.
Requirements and guidance documents - Clinical radiology
Specific Documents for the accreditation scheme
Instructions and guidelines for meeting accreditation requirements:
- SWEDAC DOC 01:31 | Internal and External Controls
- SWEDAC DOC 01:55 | Validation/Verification of Quantitative and Qualitative Methods
- SWEDAC DOC 06:7 | Measurement Uncertainty and Comparison of Results Between Methods, Equipment, and Units within Imaging and Functional Medicine
General documents for the conformity assessment
Activity 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
Requirements and guidance documents - Clinical pharmacology
Specific Documents for the Accreditation Scheme
Instructions and Guidelines for Meeting Accreditation Requirements:
- European Guidelines for Workplace Drug and Alcohol Testing in Hair
- European Guidelines for Workplace Drug Testing in Exhaled Breath
- European Guidelines for Workplace Drug Testing in Oral Fluid
- European Guidelines for Workplace Drug Testing in Urine (only applicable for workplace testing)
- SWEDAC DOC 01:31 | Internal and External Controls
- SWEDAC DOC 05:2 | Qualitative Studies – Estimation and Control of Uncertainty in Laboratory Medicine
General Documents for the Conformity Assessment
Activity 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
Requirements and guidance documents - Clinical genetics
Specific Documents for the Accreditation Scheme
Instructions and Guidelines for Meeting Accreditation Requirements:
Instructions and Guidelines for Meeting Accreditation Requirements:
- SWEDAC DOC 01:31 | Internal and External Controls
General Documents for the Conformity Assessment
Activity 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
Requirements and guidance documents - Clinical Immunology and Transfusion Medicine
Specific Documents for the Accreditation Scheme
Instructions and Guidelines for Meeting Accreditation Requirements:
- SWEDAC DOC 01:31 | Internal and External Controls
- SWEDAC DOC 05:2 | Qualitative Studies – Estimation and Control of Uncertainty in Laboratory Medicine
General Documents for the Conformity Assessment
Activity 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
Requirements and guidance documents - Clinical Chemistry
Specific Documents for the Accreditation Scheme
Instructions and Guidelines for Meeting Accreditation Requirements:
Instructions and Guidelines for Meeting Accreditation Requirements:
- European Guidelines for Workplace Drug Testing in Urine (only applicable for workplace testing)
- SWEDAC DOC 01:31 | Internal and External Controls
- SWEDAC DOC 05:2 | Qualitative Studies – Estimation and Control of Uncertainty in Laboratory Medicine
General Documents for the Conformity Assessment
Activity 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
Requirements and guidance documents - Clinical Microbiology
Specific Documents for the Accreditation Scheme
Instructions and Guidelines for Meeting Accreditation Requirements:
Instructions and Guidelines for Meeting Accreditation Requirements:
- SWEDAC DOC 01:31 | Internal and External Controls
- SWEDAC DOC 05:2 | Qualitative Studies – Estimation and Control of Uncertainty in Laboratory Medicine
General Documents for the Conformity Assessment
Activity 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
Requirements and guidance documents - Clinical Autopsy
Specific Documents for the Accreditation Scheme
Instructions and Guidelines for Meeting Accreditation Requirements:
Instructions and Guidelines for Meeting Accreditation Requirements:
- SWEDAC DOC 15:3 | Guidance for Accreditation of Clinical Autopsy
General Documents for the Conformity Assessment
Activity to be Met for Accreditation to be Granted:
- SS-EN ISO/IEC 17020:2012 | Conformity Assessment – Requirements for the Operation of Various Types of Bodies Performing Inspection
- STAFS 2020:1 | Swedac’s Regulations and General Guidelines on Accreditation
Instructions and Guidelines for Meeting Accreditation Requirements:
- ILAC G24:2022 | Guidelines for the Determination of Recalibration Intervals of Measuring Equipment
- ILAC P15:05/2020 | Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies
- 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 05:6 | 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 15:4 | Guidance for the Assessment of Inspection Bodies Against SS-EN ISO/IEC 17020:2012
- SWEDAC DOC 18:2 | Guidance on Measurements Performed as Part of an Inspection Process
- SWEDAC DOC 20:1 | Swedac’s Policy for Referencing Accreditation
Requirements and guidance documents - Clinical Pathology
Specific Documents for the Accreditation Scheme
Instructions and Guidelines for Meeting Accreditation Requirements:
Instructions and Guidelines for Meeting Accreditation Requirements:
- SWEDAC DOC 01:31 | Internal and External Controls
- SWEDAC DOC 17:1 | Guidance for Diagnosis on Digital Images and Remote Diagnosis in Clinical Pathology
General Documents for the Conformity Assessment
Activity 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