» Information for Assessors and Laboratories

Medical Laboratories and Technical Assessors may find the following documents useful.


Links to Technical Bulletins:

June 2020

Guidance on application for accreditation to include COVID-19 testing

The purpose of this document is to provide guidance to applicant laboratories for COVID-19 testing (ISO 15189 or ISO/IEC 17025).

November 2019

Guidance on Extension to Scope for ISO 15189:2012 Accredited Medical Laboratories

This document is intended to provide general guidance to accredited medical laboratories on whether a formal extension to scope application is required when changes are made within a fixed scope of accreditation.

September 2019

Accreditation of medical laboratory examination/test processes delivered between multiple legal entities

This document outlines the UKAS assessment approach where the applicant or accredited laboratory does not directly manage all stages of the end to end process; in other words where critical parts of the pre-examination, examination/testing or post examination process are carried out by (an)other laboratory/laboratories

June 2018

Medical Laboratories: Maintaining UKAS Accreditation During Periods of Change

This document covers aspects of medical laboratory change of legal entity, change of name and extensions to scope of accreditation

November 2017

UKAS Position Paper: Assessment of a Medical Laboratory’s approach to the assurance of clinical staff competence and use of EQA

This paper, developed by the UKAS Medical Laboratory Technical Advisory Committee, is intended to clarify requirements of ISO 15189:2012 and UKAS’ expectations of how a medical laboratory demonstrates the competence of its clinical staff


Assessor Guidance and Information Documents:

MED 1200 Potential challenges when assessing organisational processes for assurance of clinical competence in labs with limited clinical staff resource (May 2018)
MED 1201 Assessor Guidance: Assessment and Accreditation of Medical Laboratory Services Delivered Off-site (April 2019)



Further information: