商品簡介
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.
目次
Section I: Establishing the Need
Introduction
What Manuals?
Application
A Manual by Any Other Name
Manual Categories
Manual Components
Overview of Quality Assurance
What Is Quality Assurance
Quality Assurance Program Components
Responsibilities
Quality Assurance Benefits
Quality Assurance Cost
Cost of NO Quality Assurance
Quality Control
Quality Assurance Documentation
Summary
Section II: Implementation Strategies
Project Management
Overview
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
Overview
Six Sigma Foundation—DMAIC
Define
Measure
Analyze
Improve
Control
Conclusion
Outsourcing Quality Assurance Programs
Introduction
Services
Benefits
Conclusion
Section III: Policy Manual Development
Content and Format
Manual Types
Manual Categories
Manual Components
Content
Format
Operational Manuals
Definitions
Administrative Manual
Quality Manual
Health and Safety Manual
Sample Control Manual
Technical Methods Manuals
Training Manuals (TM)
Analytical Procedures
Quality Assurance Procedures
Documentation Requirements
Inventories
Criteria Files
Section IV: Appendices
Definitions
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
Index
