Implementing Quality in Laboratory Policies and Processes : Using Templates, Project Management, and Six Sigma book cover
1st Edition

Implementing Quality in Laboratory Policies and Processes
Using Templates, Project Management, and Six Sigma

ISBN 9781420073041
Published November 24, 2009 by CRC Press
1432 Pages 31 B/W Illustrations

USD $1,100.00

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Book Description

In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Laboratory Policies and Processes: Using Templates, Project Management, and Six Sigma provides templates for the various policies, procedures, and forms that should be contained in the quality assurance, operational, and technical manuals of a laboratory seeking accreditation.

Templates for the entire project life cycle

The book begins with a general introduction and overview of quality assurance and then moves on to cover implementation strategies. It contains best practices and templates for the project management of the design and implementation of the laboratory operational and technical manuals required to establish a quality assurance program. The templates span the entire project life cycle, from initiation, to planning, to execution, to monitoring, and finally, to closure. The book also examines how Six Sigma concepts can be used to optimize laboratories, and contains templates that cover administrative issues, quality assurance, sample control, and health and safety issues. In addition, there is a section of criteria files that relate the individual document templates to specific accreditation criterion.

Addresses the standards of ISO 17025

The results of any laboratory examination have the potential to be presented in court and can ultimately affect the life and liberty of the parties involved. Therefore, a stringent quality assurance program, including well-documented policies and a procedure manual, is essential. Ensuring that laboratories meet the standards of ISO 17025, this volume is a critical component of any laboratory’s accreditation process.

Table of Contents

Section I: Establishing the Need


What Manuals?


A Manual by Any Other Name

Manual Categories

Manual Components

Overview of Quality Assurance

What Is Quality Assurance

Quality Assurance Program Components


Quality Assurance Benefits

Quality Assurance Cost

Cost of NO Quality Assurance

Quality Control

Quality Assurance Documentation


Section II: Implementation Strategies

Project Management


What Is Project Management?

What Is a Project?

What Are the Phases of a Project?

Project Initiation

Project Planning

Project Execution

Project Monitoring and Control

Project Closure

Overview of Six Sigma


Six Sigma Foundation—DMAIC







Outsourcing Quality Assurance Programs





Section III: Policy Manual Development

Content and Format

Manual Types

Manual Categories

Manual Components



Operational Manuals


Administrative Manual

Quality Manual

Health and Safety Manual

Sample Control Manual

Technical Methods Manuals

Training Manuals (TM)

Analytical Procedures

Quality Assurance Procedures

Documentation Requirements


Criteria Files

Section IV: Appendices


Administrative Policy Document Templates

Administrative Policy Manual Template

Quality Policy Document Templates

Quality Policy Manual Template

Safety Policy Document Templates

Safety Manual Template

Sample Control Document Templates

Sample Control Manual Template

Technical Manual Template

ISO 17025 Criteria File

ASCLD/LAB (Legacy) Criteria File

Policy/Procedure Association Templates

Project Management Templates


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...The authors do deserve applause for preventing repetitions, which are the norm, rather than exceptions, in books of this kind ... it is an important book which describes how quality has to be managed in any laboratory...
—Puneet Setia and Avneesh Gupta, in Anil Aggrawal's Internet Journal of Forensic Medicine and Toxicology, Volume 11, Number 2, July - December 2010