ISO 9001

ISO 9001:2000

ISO 9001:2000 Quality Management Systems - Requirements contains the general requirements for a quality management system. The standard is applicable to all companies including manufacturing and service providers. The most recent revision was in 2000. The ISO 9001 standard is on a regular schedule of review and improvement.

The American Society for Quality publishes this standard in the US. All ISO standards are available through the International Standardization Organization.

New Format

In the most recent revision (2000) the text was reworded for easier adaptation to a wider range of organizations. Some definitions have changed.

"Subcontractor" has been changed to "supplier".
"Supplier" now refers to the main organization seeking certification.
"Customer" remains unchanged.

The standard has a new process-oriented structure. It includes a process model based on the Plan-Do-Check-Act cycle, which outlines the product and/or service cycle and the management control cycle.

The old 20-point format has been replaced. The text of the standard is now organized into five major auditable processes. A brief description of the sections can be found through the links below.

Section 4. Quality Management System

Section 5. Management Responsibility

Section 6. Resource Management

Section 7. Product Realization

Section 8. Measurement, Analysis, and Improvement

Documentation requirements are less-prescriptive, and allow greater flexibility.

New Requirements

Higher Focus on the Customer
Organizations must determine customer needs and expectations and, as a new requirement, monitor customer satisfaction and/or dissatisfaction.

Measurable Objectives Must be Established
Increased emphasis is placed on the role of top management to develop and improve the system, integrate legal and regulatory requirements, and establish measurable objectives at appropriate levels of the organization.

Measurement and Continual Improvement Required, not Implied
Measurement-monitoring activities are a new requirement. Organizations must determine needs and uses of "applicable methodologies," including statistical techniques. Also, data must be used to determine the performance of the quality system and to identify improvements. Results of data analysis and improvement must be part of management review.

Training effectiveness must be evaluated
Evidence that training has been provided will not be enough. An evaluation of the effectiveness of training will now be required.

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