Thursday, April 28, 2005

Partnering to Promote an Understanding of ISO 15189:2003

Linda Crawford, Julie Coffey, and Harold Richardson.

The Quality Management Program – Laboratory Services provides accreditation to ISO 15189:2003. Partnering with the Standards Council of Canada and the Entidad Mexicana de Acreditación, it developed a course to familiarize laboratory personnel with this international standard.

To illustrate ISO 15189:2003, recognize differences from other standards, know how to apply this standard, and how to assess conformance to it.

Two instructors delivered a five-day course utilizing lectures and group exercises. Sixteen presentations were delivered and seven group exercises conducted. A final written examination was administered.

Twenty-four individuals attended the course in Mexico City from October 4-8, 2004. Lectures covered an introduction, background and overview of ISO 15189:2003 in medical laboratories, document/record control, quality manuals, measurement analysis and improvement, referrals, personnel, accommodation and environmental conditions, laboratory equipment/supplies, pre-examination procedures, examination procedures and quality assurance, post-examination procedures and reporting, safety, and assessment processes. Content was drawn from Plus 15189 the ISO 15189:2003 essentials – a practical handbook for implementing the ISO 15189:2003 standard for medical laboratories (Canadian Standards Association, 2004). Group exercises were incorporated throughout the five days. Case studies were used in the group exercises to highlight clauses within the standard, illustrate how they apply in practice, and demonstrate how to assess conformance to them. They reinforced the lecture content and focused on quality management systems, quality management and document control, measurement analysis and improvement, referrals, resources, pre-examination, quality control and post-examination. Comparisons were provided to ISO 9000:2000, 17025 and 15190. A final examination consisted of 26 true/false or multiple-choice questions and six conformity assessment scenarios. For each scenario, students identified at least one applicable conforming and one non-conforming clause from ISO 15189:2003. Certificates of completion were presented to all attendees.

A comprehensive course can be successfully delivered to familiarize laboratory personnel with ISO 15189:2003.

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