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Clin Biochem. 2013 Sep;46(13-14):1187-93. doi: 10.1016/j.clinbiochem.2013.04.028. Epub 2013 May 3.

Role of a quality management system in improving patient safety - laboratory aspects.

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Headwaters Health Care Centre, Orangeville, Ontario, Canada.



The aim of this study is to describe how implementation of a quality management system (QMS) based on ISO 15189 enhances patient safety.


A literature review showed that several European hospitals implemented a QMS based on ISO 9001 and assessed the impact on patient safety. An Internet search showed that problems affecting patient safety have occurred in a number of laboratories across Canada. The requirements of a QMS based on ISO 15189 are outlined, and the impact of the implementation of each requirement on patient safety is summarized. The Quality Management Program - Laboratory Services in Ontario is briefly described, and the experience of Ontario laboratories with Ontario Laboratory Accreditation, based on ISO 15189, is outlined.


Several hospitals that implemented ISO 9001 reported either a positive impact or no impact on patient safety. Patient safety problems in Canadian laboratories are described. Implementation of each requirement of the QMS can be seen to have a positive effect on patient safety. Average laboratory conformance on Ontario Laboratory Accreditation is very high, and laboratories must address and resolve any nonconformities. Other standards, practices, and quality requirements may also contribute to patient safety.


Implementation of a QMS based on ISO 15189 provides a solid foundation for quality in the laboratory and enhances patient safety. It helps to prevent patient safety issues; when such issues do occur, effective processes are in place for investigation and resolution. Patient safety problems in Canadian laboratories might have been prevented had effective QMSs been in place. Ontario Laboratory Accreditation has had a positive impact on quality in Ontario laboratories.


A2LA; APLAC; American Association for Laboratory Accreditation; Asia Pacific Laboratory Accreditation Cooperation; CAR; CSA; Canadian Standards Association; EQA; External Quality Assessment; IFCC; IQMH; ISO; ISO 15189; Institute for Quality Management in Healthcare; International Federation of Clinical Chemistry and Laboratory Medicine; International Organization for Standardization; MOHLTC; NSS; National Standards System; OLA; OMA; Ontario Laboratory Accreditation; Ontario Medical Association; Ontario Ministry of Health and Long-Term Care; PAR; Patient safety; QC; QMP-LS; QMS; Quality Management Program — Laboratory Services; Quality management; Quality management system; SCC; Standards Council of Canada; corrective action report; preventive action report; quality control; quality management system

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