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Interview
Q&A: Sheila Woodcock, champion of quality management in medical laboratories

May 28, 2021

Q&A: Sheila Woodcock, champion of quality management in medical laboratories

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Interview
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Sheila Woodcock is a quality management specialist who founded QSE Consulting. She has more than 40 years of experience in health care, education and professional regulation. Sheila is the Convenor leading the ISO working group ISO/TC 212 WG1 Quality and competence in the medical laboratory. The working group is part of the technical committee for Clinical Laboratory Testing and In Vitro Diagnostic Test Systems, ISO /TC212.

Q.

What are some of Canada’s key contributions to advancing the work of the technical committee on Clinical laboratory testing and in vitro diagnostic test systems, ISO/TC 212?

A.

The people and their expertise on the subject matter. The technical committee’s most popular standard is ISO 15189 Medical laboratories – Requirements for quality and competence. Two Canadians led the development of the original main document used for laboratory accreditation to ISO 15189 and I am currently co-leading the revision of the standard.

Canada holds leadership roles on ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems. This includes one convenor and one deputy convenor.

Canadians were very involved in developing both ISO/TS 20658 Medical laboratories – Requirements for sample collection, transport, receipt and handling, and ISO/TS 20914 Medical laboratories — Practical guidance for the estimation of measurement uncertainty. We’ve hosted meetings in Vancouver and Toronto – delegates love coming to Canada!

The biorisk management standard for laboratories, ISO 35001:2019, was also based on Canadian documents.

Q.

ISO/TC 212 contributes 20 standards to the United Nations Sustainable Development Goals for Good Health and Well-Being; Quality Education; Industry, Innovation and Infrastructure; and Responsible Consumption and Production. What are some of the committee’s top priorities for the next five years?

A.

The committee aims to further enhance the quality of laboratory services globally. Our technical committee chair conducted research to determine how clinical standards are used and found that ISO 15189 is overwhelmingly used more than any other document from our committee. The standard’s core content outlines what needs to be done to ensure quality, and it is supported by a number of supplemental documents that specify how to achieve quality (ISO 15190, ISO 22367, ISO/TS 20658, ISO/TS 20914).

Q.

As a Canadian leader in international standardization, what are you most proud of?

A.

Representing Canada! Canada is widely respected, especially in ISO/TC 212. We are not known as dominant or coming to meetings with an agenda. We’re very consensus driven. A lot more Canadians have joined the committee in the last nine years.

We’ve reduced publication timelines by making our processes more efficient. We integrate technology and ISO’s enhanced resources to continuously improve. Our mirror committee has seen an increase in the financial support we receive from vendors.

Participation in international technical committees, such as ISO/TC 212, allows experts to shape standards that impact them. Find more opportunities to get involved in standardization activities.

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