Learning Outcomes

ISO 15189 and Quality Regulations for Medical Laboratories

Navigating the Changes

Terms and Definitions in ISO 15189

Structural and Governance Requirements

Requirements for Environmental Conditions

Lesson Summary

This module introduces you to ISO 15189, its implications for medical laboratories, and its comparison with its previous version. The module also explains terms and definitions used in the standard along with various critical requirements, such as structural, governance, risk management, resource, and environmental conditions.

ISO 15189 - Requirements for Reagents and Consumables

Laboratory Process Requirements

Examination Process Requirements in ISO 15189

This module explains ISO 15189:2022 requirements regarding reagents and consumables in the laboratory. It also describes the requirements for laboratory information for patients and instructions about sample collection and transport. The module also discusses the examination process requirements and ways to evaluate measurement uncertainty.

Requirements - Post-Examinations and Non-conformities

Management of System Requirements and Record Control

Improvement Requirements and Corrective Actions

In this module, we will explain post-examination and reporting requirements for laboratories of ISO 15189. It also presents requirements for the laboratories to enact a robust management system. Lastly, the requirements regarding improvement and the ways to take corrective actions against nonconformities are also explained in this module.

ISO 15189:2022 - Medical Laboratories' Quality Assurance & Competence - Course Assessment

Learn the requirements of ISO 15189 regarding quality regulations of operations of medical laboratories.

ISO 15189:2022 - Medical Laboratories' Quality Assurance & Competence

ISO 15189 is an international standard developed by the ISO. It helps medical laboratories to be quality oriented and competent in their operations. The most recent version of this standard was introduced in 2022, and this course explains all its major requirements. By taking this course, you can opt for a career as a quality regulator for medical laboratories. This course can also help you become proficient as a QMS professional.

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