Implementation of ISO 9001 in a medical testing laboratory |
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Authors: | L Burnett Colin Rochester Mark Mackay Anné Proos Warwick Shaw Gabe Hegedus |
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Institution: | (1) Department of Clinical Chemistry and Molecular Genetics, Institute of Clinical Pathology and Medical Research, Westmead Hospital, Westmead NSW 2145, Australia Tel.: +61 2 9845 6177; Fax: +61 2 9845 7947 e-mail: LeslieB@westmed.wh.su.edu.au, AU |
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Abstract: | The Department of Clinical Chemistry and Molecular Genetics, within the Institute of Clinical Pathology and Medical Research
at Westmead Hospital, is a medical testing laboratory operating within the public sector health system of New South Wales,
Australia. It provides acute-care pathology services to Westmead Hospital (a 900-bed tertiary referral university teaching
hospital) as well as to three district hospitals and three rural hospitals. In addition to these core clinical chemistry services,
it offers approximately 150 specialised biochemistry, pharmacology, toxicology, trace metal and molecular genetics assays
as a reference laboratory service. In 1993, the Department became Australia's first medical testing laboratory to be registered
to ISO 9001-1987/AS3901-1987. In 1995, this certification was extended to AS/NZS ISO 9001-1994. We are currently preparing
for further accreditation to ISO/IEC Guide 25-1990, with additional supplementary requirements for medical testing. This paper
describes the Quality System that the Department developed and which has been successfully maintained and extended since original
certification. Important features of the Quality System are:
1. Primary design of the Quality System to meet medical and customer needs, with subsequent addition of required ISO elements.
2. Use of national Quality Award criteria to identify key business processes.
3. Development of integrated technical non-conformance, customer complaint, staff suggestion, and quality system corrective
action procedures.
4. Implementation without external resources.
Our conclusions are that ISO 9000 Quality Systems can be applied to medical testing laboratories, and can be implemented with
minimum resource costs. Improvements in technical and service quality and business performance have resulted from this process.
However, implementation of ISO 9000 at the level of individual Departments is not ideal. Greater improvements are possible
when this process is undertaken at the level of the entire organisation.
Received: 9 September 1996 Accepted: 5 October 1996 |
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Keywords: | ISO 9000 Quality System Clinical chemistry Medical testing Pathology Health care |
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