Preface The primary objective of this handbook is to provide both novice and experienced quality practitioners with a concise, user-friendly guide to understanding and implementing the requirements of the ISO 9001 quality management standard. The ISO 9000 family of standards has undergone three revisions. Initially published in 1987, ISO 9001 was revised in 1994, 2000, and, most recently, in 2008. Introduction 0.1 General The ISO 9000 family of standards was developed to assist organizations, of all types and sizes, to implement and operate an effective quality management system (QMS). It is made up of four core standards: a) ISO 9000:2005, entitled Quality management systems - Fundamentals and vocabulary, describes the fundamentals of a QMS and specifies the terminology for a QMS. b) ISO 9001:2008 specifies requirements for a QMS where an organization needs to demonstrate its ability to provide products that meet customer requirements and applicable regulatory requirements and aims to enhance customer satisfaction. c) ISO 9004:2000, entitled Quality management systems - Guidelines for performance improvement, provides guidelines for both the effectiveness and efficiency of the QMS. The aim of this standard is the improvement of the performance of an organization and the satisfaction of customers and other interested parties. Note: At time of printing, this standard is under development with a new edition planned for mid-2009. d) ISO 19011:2002, entitled Guidelines for quality and/or environmental management systems auditing, provides guidance on auditing quality and environmental management systems, and was developed by both ISO/TC 176 and ISO/TC 207. The ISO/TC 207 is responsible for the ISO 14000 family of environmental management system standards. Together the four ISO documents form a coherent set of QMS standards facilitating mutual understanding for national and international trade.