Laboratory Quality Management System – Handbook pdf download

Manostaxx - Industrial Management Consulting
Manostaxx – Industrial Management Consulting

Achieving, maintaining and improving accuracy, timeliness and reliability are major
challenges for health laboratories. Countries worldwide committed themselves
to build national capacities for the detection of, and response to, public health
events of international concern when they decided to engage in the International
Health Regulations implementation process.

Only sound management of quality in health laboratories will enable countries
to produce test results that the international community will trust in cases of
international emergency.

This handbook is intended to provide a comprehensive reference on Laboratory
Quality Management System for all stakeholders in health laboratory processes,
from management, to administration, to bench-work laboratorians.

This handbook covers topics that are essential for quality management of a public
health or clinical laboratory. They are based on both ISO 15189 and CLSI
GP26-A3 documents.

Each topic is discussed in a separate chapter. The chapters follow the framework
developed by CLSI and are organized as the “12 Quality System Essentials”. A
diagram representing these 12 essentials is shown below.

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