» Information for Assessors and Laboratories
Medical Laboratories and Technical Assessors may find the following documents useful.
Links to Technical Bulletins:
The purpose of this document is to provide guidance to applicant laboratories for COVID-19 testing (ISO 15189 or ISO/IEC 17025).
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.
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
This document covers aspects of medical laboratory change of legal entity, change of name and extensions to scope of accreditation
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: