ISO 9000 Faces Complete Restructuring
The ISO 9000 quality management systems (QMS) standards are set to take on a completely different look under revisions slated for release in mid to late November or early December.
The International Organization for Standardization (ISO) requires all of its standards to be reviewed every five years to determine whether they should be confirmed, revised or withdrawn.
ISO 9000, first released in 1987, underwent limited revisions in 1994. A more thorough revision was begun by ISO Technical Committee (TC) 176, Quality Management and Quality Assurance, in 1996, with Subcommittee (SC) 2, Quality Systems, developing revision drafts.
The First Committee Draft (CD1) of the ISO 9000: 2000 standards was released in July 1998, with the Second Committee Draft (CD2) published in February 1999, the Draft International Standard (DIS) released in November 1999 and the Final Draft International Standard (FDIS) published in September. These drafts consist of four primary standards, replacing more than 20 standards and documents.
The four primary standards are ISO 9000: Quality Management Systems - Fundamentals and Vocabulary, replacing ISO 9000-1 and 8402; ISO 9001: Quality Management Systems - Requirements, replacing ISO 9001, 9002 and 9003; ISO 9004: Quality Management Systems - Guidelines for Performance Improvements, replacing ISO 9004-1; and ISO 19011: Guidelines for Auditing Management Systems, replacing ISO 10011-1, 10011-2 and 10011-3, as well as the ISO 14010, 14011 and 14012 environmental auditing standards.
Other old ISO 9000 standards and documents are being reviewed by ISO/TC 176 for incorporation into the new standards, withdrawal or reissue as technical reports.
The new standards, particularly ISO 9001, are being designed to be more generic, follow a process-based structure and be more compatible with the ISO 14000 series of environmental management systems (EMS) standards, allowing for integrated management systems.
Under the 2000 revisions, ISO 9001 becomes more generic through the new option of being tailored to omit requirements that don't apply to an organization or limiting the scope of application under Section 1.2, Application . This eliminates the need for the less comprehensive ISO 9002 and 9003 standards. In addition, there are no QMS documentation layout or structure requirements.
The new process-based structure, similar to that used in ISO 14001, creates a completely different look for ISO 9001. The 20 elements have been replaced by five clauses containing 23 elements. The two standards are more compatible under this approach, making it easier to integrate management systems and combine documentation.
ISO 9004, Section 4.3 and ISO 9000, Section 0.2 set forth eight quality management principles, which have been identified as forming a framework for improved performance by an organization. These principles are the basis of ISO 9001. They are:
Major clauses of ISO 9001: 2000 are:
4 Quality Management System (2 elements), which states general requirements, along with such documentation requirements as the quality manual, procedures, work instructions and records. It sets the general framework to establish a quality management system, which defines and manages processes in order to produce a good product or service and allow for continual improvement.
5 Management Responsibility (6 elements), under which management defines policy, objectives, planning and quality management system requirements, while providing for feedback through management review for change authorization and initiation of improvement. It addresses management's responsibility to establish a system that continually meets customer needs and expectations, even in times of organizational change. This responsibility includes quality objectives at each organizational function and level.
6 Resource Management (4 elements), where necessary resources, such as human resources and facilities, are determined and applied. Theses resources, which include new elements covering infrastructure and work environment, are required to implement and maintain the quality management system.
7 Product Realization (6 elements), under which processes, such as customer-related processes, design, purchasing, and production and service provision, are established and implemented. These processes are needed to manufacture product and/or deliver services from receipt to delivery. Organizations must define and describe their unique business processes, but are not obliged to use the standard's structure.
8 Measurement, Analysis and Improvement (5 elements), where results are measured, analyzed and improved through internal audits, nonconformity control and continual improvement. Organizations are required to measure and monitor processes, and product and/or service conformity. Collected data must be analyzed to initiate corrective and preventive action for continual improvement.
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