PLUS 9001

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 ISO 9001:2000. The ISO 9000 family of Standards has undergone two revisions. Initially published in 1987, it was revised in 1994 and in 2000. The first part of the handbook is made up of three subsections: "Foreword", "Conceptual Overview", and "Implementation Path". The "Foreword" outlines the background of the ISO 9000:2000 family of standards and describes the changes that have occurred in these standards, compared with their 1994 versions. The "Conceptual Overview" describes some of the basic concepts, to help understand the fundamentals associated with quality management systems (QMS). Finally, the "Implementation Path" suggests an approach for QMS registration, and discusses of conformity assessment by third-party registration bodies (registrars) and accreditation bodies. The second part of the handbook is also made up of subsections that are numbered according to corresponding clause numbers in ISO 9001:2000. This facilitates reading by allowing a direct link to all clauses of ISO 9001:2000 and ISO 9004:2000. Section 2 also contains - the actual text of ISO 9001:2000 - guidance, made up of excerpts from ISO 9000-2:97, as well as other information available to the CAC/ISO/TC 176 (Canadian Advisory Committee to the ISO Technical Committee 176) and members of the editorial team - numerous definitions extracted from ISO 9000:2000 - typical audit questions useful for organizations seeking to implement a QMS based on ISO 9001:2000 - self-diagnostic questions to be used by an organization while preparing its quality management system Finally, in Section 3, several diagrams, tables, and appendices are provided to help understand the 9000:2000 family and its relationship to ISO 9001:1994. The figures and tables were kindly provided by Dr. Pierre F. Caillibot, Chair of the ISO/TC 176, by Pierre Landry, of the Medical Devices Bureau of Health Canada, and convener of ISO/TC 176/WG2, and by Denis Pronovost of Accademia Qualitas, a private organization that teaches the application of ISO 9000 principles.