The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard.

The Laboratory Quality Assurance Manual:

• Incoporates changes to ANSI/ISO/ASQ 9001-2000 pertaining to laboratories.
• Provides blank forms used in preparing a quality manual.
• Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001-2000

Contents

Laboratory Quality System Elements

• Quality Policies.
• Quality Objectives.
• Management of the Quality Manual.
• Control of Quality Documentation and Records.
• Customer Focus.
• Quality System Planning.
• Organization for Quality.
• Communications.
• Management Review.
• Human Resources.
• Laboratory Infrastructure.
• Work Environment.
• Quality in Procurement.
• Sample Handling, Identification, Storage, and Shipping.
• Chain-of-Custody Procedures.
• Laboratory Testing and Control: Intra-and Interlaboratory Proficiency Testing.
• Design and Development (Excluded).
• Customer Property (Excluded).
• Control of Measuring and Test Equipment.
• Preventive Maintenance.
• Estimate of Uncertainty of Measurement.
• Reference Standards and Standard Reference Materials.
• Data Validation.
• Measurement, Analysis, and Improvement of the Quality System.
• Statistical Methods.
• Subcontracting Services and Supplies.
• Quality Audits.
• Nonconformity.
• Customer Satisfaction and Complaints.
• Corrective and Preventive Action.
• Method Validation.
• Reliability.
• Quality Cost Reporting.

How to Write a Laboratory Quality Assurance Manual

• Organizing for Preparation of the Manual.
• Establishing Objectives and Priorities.
• Collection and Review of Existing Procedures.
• Preparation of a Flowchart.
• Identification of Program Requirements.
• Identification of Shortfalls and the Assignment of Priorities.
• Writing the Manual.

XYZ Laboratory Quality Assurance Manual

Sample Quality Assurance Forms

Index

click here to see books • videos • cd-roms of related interest