Role of inspectors in external review mechanisms: criteria for selection, training and appraisal.
There is a wide consensus that an external review mechanism, both in the form of a peer review, accreditation and certification according to the ISO 9000 series, is more than its standards. The survey process, the role of inspectors and standard interpretation contribute to the essence of the programme itself. Above all, the criteria used for the selection, training and appraisal of inspectors are of paramount importance. While the ISO norms do not require certification bodies to employ "peer reviewers" for the healthcare sector, experience in this sector is the main criterion for recruiting inspectors in accreditation and peer review programmes. However, the ISO/IEC Guide 58, for the setting up and operation of a laboratory accreditation body, specifies that inspectors should have appropriate technical knowledge of the specific calibrations, tests or types of calibration or tests for which accreditation is sought. Training, updating and assessment of inspectors are clearly defined under ISO, but are also systematic under accreditation programmes. Part-time inspectors who are professionals currently practising in a healthcare facility and are in touch with the day-to-day work reality are preferred for accreditation programmes which have self-regulation, education and quality improvement as their main concerns, while full-time and external inspectors are used in external review mechanisms with registration and certification as their main concerns. As well as harmonising the standards for accreditation, it is important to obtain consensus on the criteria to use for the selection, training and assessment of inspectors in order to ensure that different national or international programmes gain mutual recognition.
Plebani
M
M
Department of Laboratory Medicine, University-Hospital of Padova, Via Giustiniani, 2, 35128, Padua, Italy. pad08821@pd.nettuno.it
D000068:Accreditation; D002568:Certification; D002624:Chemistry, Clinical / Q000193:education / Q000592:standards*; D004521:Educational Measurement; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D007753:Laboratories / Q000592:standards*; D017056:Medical Laboratory Personnel / Q000193:education / Q000592:standards*; D010380:Peer Review; D010560:Personnel Selection; D012958:Societies, Scientific