Laboratory licensing: an essential part of the national laboratory regulatory framework

ABSTRACT

This document aims to provide support and offer guidance to national health authorities and national health laboratory focal points in their efforts to strengthen laboratory systems. It defines the regulatory requirements for registration, licensing, certification and/or accreditation of health laboratories, and applies to all health laboratories (public, private not-for-profit and private-for-profit). It explains the difference between certification and accreditation, and details how these can be used throughout the licensing process to implement quality requirements.