Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. 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.

Helping human research protection program professionals create, implement, and evaluate quality assurance/quality improvement programs. Quality Assurance and Quality Improvement Handbook for Human Research is the first comprehensively designed instructional manual aimed at teaching human research protection program (HRPP) professionals how to create, implement, evaluate, and improve QA/QI programs. Geared toward institutions and individuals responsible for establishing new QA/QI programs or functions, the book offers several organizational models for consideration. It also provides practical information for improving and strengthening established programs, both big and small. Written in a conversational style, the book's step-by-step instructions make it easily accessible to those who may not be well versed in QA/QI concepts and fundamentals. Developed by the QA/QI Subcommittee of the Harvard Catalyst Regulatory Foundations, Ethics, and Law Program, which is committed to designing and strengthening QA/QI programs and functions, this volume • includes contributions by fifteen experts with diverse professional experiences from varied organizations • is enhanced with flow charts, examples, sample forms, and templates • incorporates model slide presentations and instructional materials • discusses the respective benefits and challenges of different organizational models • is applicable across many organizational types with a variety of reporting structures and available resources, including academic and medical institutions Perfect for both seasoned personnel and newcomers to the field, Quality Assurance and Quality Improvement Handbook for Human Research is a needed resource for ensuring investigative accountability. Contributors: Hila Bernstein, MS, MPH, Barbara E. Bierer, MD, Elizabeth Bowie, JD, MPH, MSc, Susan Corl, MSW, MPH, CIP, CCRP, Jacquelyn-My Do, MPH, Lisa Gabel, CIP, Alyssa Gateman, MPH, CCRP, Jennifer A. Graf, Nareg D. Grigorian, Leslie M. Howes, MPH, CIP, Jennifer Hutchinson, CIP, CPIA, Cynthia Monahan, MBA, CIP, Eunice Newbert, MPH, Sarah A. White, MPH, CIP, Elizabeth Witte, MFA