Course Description

This exciting offering from JANAAC looks at imparting the necessary knowledge to clearly understand and interpret the requirements of the ISO 15189:2022 standard.

Learning Outcomes and Topical Outline

• Develop an understanding of the structural, technical and management requirements of the ISO 15189:2022 standard

• Understand the importance of an ISO 15189:2022 Quality Management System within a medical laboratory

· Be aware of the differences between the ISO 15189:2012 and the ISO 15189:2022 standard

Pre-requisites

Basic/Fundamental knowledge of good laboratory practices, basic knowledge of quality management systems is an asset, technical knowledge of test methods in respective laboratory.

Target Attendees

· Analysts and Managers of Existing and prospective medical Laboratories

· Regulatory bodies

· Quality Management team within entities seeking accreditation or a part of an already accredited entity

· Consultants

· ISO 15189 Technical Assessors

Areas of Focus

i. The Benefits of Accreditation

ii. The Management Requirements of the ISO 15189:2022 Standard for Medical Laboratories

iii. The Technical Requirements of the ISO/IEC 17025:2017 Standard for Medical Laboratories

iv. Structuring of Management System Documentation