4.3 Accreditation

A certificate of accreditation is an official recognition of the quality and competence of a laboratory’s operations in line with international standards. It is an acknowledgement that the tests carried out by the laboratory are reliable and accurate. To achieve accreditation, laboratories are assessed by certified external experts, who review all aspects of the laboratory QMS according to recognised standards. Laboratories may be accredited for different types of work: for example, a reference laboratory may be accredited for providing clinical testing, and also separately accredited for providing a PTS.

One of the most widely recognised accreditation schemes is the International Standards Organisation (ISO) scheme. Ideally, public health laboratories should comply with the ISO 15189 quality standard, which covers both management and technical operations and is specific to clinical laboratories. Veterinary laboratories should comply with the ISO quality standard ISO/IEC 17025, which is used as a measure of the laboratory’s competence in testing and calibration activities. Compliance with country-specific standards may also be necessary for formal accreditation. In recognition of the fact that many laboratories in low- and middle-income countries will need substantial support to achieve ISO accreditation, the World Health Organization’s Regional Office for Africa (WHO AFRO, 2017) has established a framework for improving the quality of public health laboratories in developing countries, the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) programme. This framework provides a step-by-step, realistic programme for laboratories to follow to help them achieve accreditation. It incorporates its own star rating system to indicate how laboratories are performing against the simplified standard.