Laboratory Accreditation

To gain accreditation, a laboratory must be fully conversant and comply with one of the following international standards, as applicable:

ISO/IEC 17025:2017 – General requirements for the competence of testing and calibration laboratories

ISO 15189:2012 – Medical laboratories – Requirements for quality and competence

In addition, the following international standards include criteria that are used in the accreditation of specific laboratory activities:

  • ISO 15195:2018 Laboratory medicine – Requirements for the competence of calibration laboratories using reference measurement procedures (used in combination with ISO/IEC 17025:2017)
  • ISO 22870:2016 Point-of-care testing (POCT) – Requirements for quality and competence (used in combination with ISO 15189:2012)

The following publications relate to laboratories operating in the Testing, Calibration and Medical fields, including Sampling.

UKAS Publications

LAB 5 Reporting Calibration Results (Edition 4, October 2021)
LAB 11 Traceability of Temperature Measurement: Platinum Resistance Thermometers, Liquid-in-glass Thermometers and Radiation Thermometers (Edition 4, November 2012)
LAB 12 The Expression of Uncertainty in Testing (Edition 3, November 2019)
LAB 13 UKAS Guidance on the Application of ISO/IEC 17025:2017 Dealing with Expressions of Opinions and Interpretations (Edition 3, April 2019)
LAB 14 Guidance on the calibration of weighing machines used in testing and calibration laboratories (Edition 6, October 2019)
LAB 15 Traceability: Volumetric Apparatus (Edition 3, April 2019)
LAB 22 Traceability: Test Sieves (Edition 3, May 2017)
LAB 23 Traceability for Equipment used in Acoustical Testing (Edition 2, January 2007)
LAB 24 Measurement Traceability and Calibration in the Mechanical Testing of Materials (Edition 2, May 2021)
LAB 25 Traceability of Hardness Measurements (Edition 3, September 2019)
LAB 26 Calibration of Radionuclide Sources: Activity, Particle or Photon Emission Rate, Air Kerma Rate (Edition 3, February 2018)
LAB 30 Application of ISO/IEC 17025 for Asbestos Sampling and Testing (Edition 4, July 2021)
LAB 31 Use of Culture Media Procured Ready-To-Use or Partially Completed, Including Diagnostic Kits, In Microbiological Testing (Edition 3, March 2019)
LAB 32 Accreditation for Suppliers to the UK National DNA Database (Edition 5, October 2018)
LAB 33 Assessment and Accreditation of UK Official Food and Feed Laboratories and National Reference Laboratories (Edition 1, November 2021)
LAB 36 Laboratory Accommodation and Environment in the Measurement of Length, Angle and Form (Edition 4, October 2019)
LAB 37 Accreditation Requirements for Sampling and Testing in Accordance with the Drinking Water Testing Specification (DWTS) (Edition 4, February 2020)
LAB 45 Schedules of Accreditation for Calibration Laboratories (Edition 4, September 2021)
LAB 46 UKAS Policy for Participation in Measurement Audits and Interlaboratory Comparisons (Edition 4, May 2019)
LAB 48 Decision Rules and Statements of Conformity (Edition 3, June 2020)
LAB 51 UKAS Accreditation of Laboratories Performing Analysis of Toxicology Samples (Edition 1, May 2021)
M3003 The Expression of Uncertainty and Confidence in Measurement (Edition 4, October 2019)
TPS 25 Rolling Straight Edge - The Measurement of Surface Regularity of Road Pavement Surfaces - Calibration Requirements (Edition 5, March 2008)
TPS 37 Simplified Test Reports (Edition 5, October 2020)
TPS 38 The Implementation of EURAMET Calibration Guide No. 13 Guidance on Calibration of Temperature Block Calibrators (Edition 5, October 2019)
TPS 41 UKAS Policy on Metrological Traceability (Edition 5, October 2019)
TPS 47 UKAS Policy on Participation in Proficiency Testing (Edition 4, February 2020)
TPS 49 Interim Arrangements and guidance on the interpretation of IEC 61672 Sound Level Meters - Periodic Tests (Edition 2, June 2009)
TPS 53 Management system requirements of laboratories (ISO/IEC 17025 and ISO 15189) and inspection bodies (ISO/IEC 17020) - Statements for use on test, examination, calibration and inspection reports/certificates (Edition 2, June 2017)
TPS 54 UKAS Policy on Traceability of Calibration Gas Standards used in Stack Emission Monitoring (Edition 3, April 2019)
TPS 57 UKAS Policy on Selection and Use of Reference Materials (Edition 4, June 2020)
TPS 63 UKAS Policy on Deviating Samples (Edition 2, December 2019)
MED 1201 Assessor Guidance - Medical Laboratory Services Delivery Off-Site

Relevant Mandatory European and International Publications

EA-4/02 M: 2021 Evaluation of the Uncertainty of Measurement in Calibration
EA-4/17 M: 2008 EA position paper on the description of scopes of accreditation of medical laboratories
ILAC-P10:07/2020 ILAC Policy on Traceability of Measurement Results
ILAC-P14:09/2020 ILAC Policy for Uncertainty in Calibration

Relevant European and International Guidance and Informative Publications

EA -4/23 INF: 2019 The Assessment and Accreditation of Opinions and Interpretations using ISO/IEC 17025:2017
EA-4/09 G: 2017 Accreditation For Sensory Testing Laboratories
EA-4/14 INF: 2003 Selection and use of reference materials
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-G7:04/2021 Accreditation Requirements and Operating Criteria for Horseracing Laboratories
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-G24:2007 Guidelines for the determination of calibration intervals of measuring instruments
ILAC-G26:11/2018 Guidance on Implementation of a Medical Accreditation Scheme

For all available EA / ILAC publications please see the publications pages of their websites.

Guidance in interpreting the standards has been published under international agreements and adopted by UKAS. UKAS has also published or adopted other publications concerned with specialised aspects of testing and calibration. Even if a publication is applicable to only part of a laboratory’s activities, compliance with the requirements in the publication is still mandatory. Laboratories (including applicant laboratories) and assessors/auditors must read the UKAS Publications List (M4), which can be accessed via the Publications home page, to check for publications with which they have to comply.