Guidelines on Establishment of Accreditation of Health Laboratories
Dr Panadda Silva





Contents
Preface _____________________________________________________________ v
1. Accreditation and quality system____________________________________ 1
1.1 Quality system ___________________________________________________ 2
1.2 Status of accreditation in countries of South-East Asia Region _____________ 4
1.3 International accreditation agencies __________________________________ 6
2. Guiding principles for the establishment of accreditation _______________ 8
2.1 Setting up an accreditation body ____________________________________ 8
2.2 Key elements of the accreditation body ______________________________ 10
2.3 Standards ______________________________________________________ 12
3. Implementation of accreditation ___________________________________24
3.1 Development of national policy ____________________________________ 24
3.2 Establishment of accreditation body _________________________________ 24
3.3 Formulation and dissemination of standards __________________________ 25
3.4 Development of process of accreditation ____________________________ 26
3.5 Collaboration with other stakeholders _______________________________ 30
3.6 Factors to be considered in implementation __________________________ 32
3.7 Critical factors determining success__________________________________ 35
Further reading______________________________________________________38
Abbreviations and acronyms___________________________________________39
Annex 1 ___________________________________________________________40

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