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An audit questionnaire that examines specifically the management of technical activities clauses in ISO 15189

Citation

Hartley, TF, An audit questionnaire that examines specifically the management of technical activities clauses in ISO 15189, Indian Journal of Clinical Biochemistry, 25, (1) pp. 92-98. ISSN 0970-1915 (2010) [Refereed Article]

DOI: doi:10.1007/s12291-010-0019-9

Abstract

The aim of this study was to design an audit questionnaire that focuses on the management of the technical activities in a Diagnostic Pathology Laboratory. The ISO 15189 Standard is written in such a way that it continually moves back and forth from topics where the auditor needs to question bench level staff, to topics where the auditor needs to question Technical Management Staff. This makes for a disjointed audit process - both Bench Staff and Technical Managers are repeatedly interrupted. The solution was to do a clause by clause analysis of the Standard and assign the major responsibility for the compliance to each clause to either Technical Managers or Bench Staff. The Clauses were then grouped under four topic headings regardless of whether they were a Section 4 or Section 5 Clause. Two questionnaires have emerged - the one described in this work and one directed primarily towards the activities of bench staff. There are 95 questions and it takes approximately two hours to complete.

Item Details

Item Type:Refereed Article
Research Division:Medical and Health Sciences
Research Group:Other Medical and Health Sciences
Research Field:Medical and Health Sciences not elsewhere classified
Objective Division:Health
Objective Group:Health and Support Services
Objective Field:Diagnostic Methods
Author:Hartley, TF (Dr Thomas Hartley)
ID Code:62662
Year Published:2010
Deposited By:Health Sciences A
Deposited On:2010-03-16
Last Modified:2011-05-16
Downloads:0

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