The establishment of quality systems in veterinary diagnostic testing laboratories in developing countries: experiences with the FAO/IAEA External Quality Assurance Programme

Colling, Axel; Jeggo, Martyn; Louvandini, Hélder; Lelenta, Mamadou; Robinson, Mark

doi:10.1007/s00769-007-0329-7

Cited by 2 publications

(1 citation statement)

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“…Some regulatory bodies offer cost-free pre-assessment, which helps to define the scope of accreditation. The OIE Reference Laboratories, and international organisations such as the Food and Agriculture Organization of the United Nations and the International Atomic Energy Agency, provide training and offer enrolment in proficiency test rounds to facilitate development of a culture of quality within a testing laboratory (17).…”

Section: Discussionmentioning

confidence: 99%

Quality standards and guidelines for test validation for infectious diseases in veterinary laboratories

Newberry¹,

Colling²

2021

Rev. Sci. Tech. OIE

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The World Organisation for Animal Health Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Chapter 1.1.1. summarises the most relevant governance and managerial aspects of veterinary testing laboratories, and Chapter 1.1.5. introduces quality management. Both chapters are based on the International Organization for Standardization/International Electrotechnical Commission standard ISO/IEC 17025:2005 'General requirements for the competence of testing and calibration laboratories'. This paper provides an update of standards and regulatory bodies relevant for accreditation of quality management systems (QMS), with a focus on ISO/IEC 17025:2017 for testing and calibration laboratories. Important issues and considerations that a laboratory should address in the design and maintenance of its QMS are highlighted and examples provided, in particular aspects of test validation and verification, including measurement uncertainty (MU). A QMS aims to address all aspects of the laboratory operation, including staff, organisational structure, processes, and procedures. Accreditation of a diagnostic laboratory requires three notable components: a) independent or thirdparty assessment; b) suitably validated tests performed by proficient laboratory operators in an adequately equipped laboratory; and c) ongoing internal and external quality control. Together, these components ensure a test outcome is the result of a standardised process and structured peer review, and demonstrate both competency and ability to produce technically valid diagnostic results that will meet the needs of customers -veterinarians, animal owners, regulators, organisations and industry -as well as the needs of decision-makers involved in animal health and surveillance programmes.

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Section: Discussionmentioning

confidence: 99%