1st Edition

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

    1432 Pages 31 B/W Illustrations
    by CRC Press

    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.

    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



    Donnell R. Christian Jr., Stephanie Drilling

    ...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