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

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.

Preface

Section I : Establishing the Need
Chapter 1 : Overview of Quality Assurance

Section II : Implementation Strategies
Chapter 2 : Project Management
Chapter 3 : Overview of Six Sigma
Chapter 4 : Outsourcing Quality Assurance Programs

Section III : Policy Manual Development
Chapter 5 : Content and Format
Chapter 6 : Operational Manuals
Chapter 7 : Technical Methods Manuals
Chapter 8 : Criteria Files

Section IV : Appendices
Appendix A : Definitions
Appendix B : Administrative Policy Document Templates
Appendix C : Administrative Policy Manual Template
Appendix D : Quality Policy Document Templates
Appendix E : Quality Policy Manual Template
Appendix F : Safety Policy Document Templates
Appendix G : Safety Manual Template
Appendix H : Sample Control Document Templates
Appendix I : Sample Control Manual Template
Appendix J : Technical Manual Template
Appendix K : ISO 17025 Criteria File
Appendix L : ASCLD/LAB (Legacy) Criteria File
Appendix M : Policy/Procedure Association Templates
Appendix N : Project Management Templates
Index