Sawin, Stephen D.; Hutchens, Spencer, Jr. (1991, ASQC) Intertek Services Corporation, Fairfax, VA
This paper discusses the evolution of the ISO (the International Organization for Standardization), the European Community (EC), the ISO 9000 series, and the certification process; it also presents the benefits as well as the pitfalls in pursuing certification.
The ISO 9000 Quality Management System (QMS) standards, adopted by the EC as EN 29000, were developed to ensure consistency of product quality and reliability, and QMS has been a critical element of initiatives like Total Quality Management (TQM) and the Malcolm Baldrige National Quality Award (MBNQA). Adoption of the ISO 9001 standard has replaced the Good Manufacturing Practice (GMP) standards.The certification process, which can take from 15 to 18 months, has four stages: Stage I is Determination for Readiness; Stage II is Preparation Services; Stage III is Documentation Review and Assessment; and Stage IV is Assessment Review, Certification, and Registration. Statistics on the certification process indicate: (1) 70% of all companies who do not pursue pre-assessment or preparation services fail the assessment the first time, and (2) 50% of all problems associated with this high failure rate are related to five clauses of the standard: documentation control, design control, purchasing, inspection and test, and process control.
Good Manufacturing Practice (GMP),European Community (EC),ISO 9000,International Standards Organization (ISO),Malcolm Baldrige National Quality Award (MBNQA),Standards and specifications,Total Quality Management (TQM),Certification