Quality Management Systems: ISO 9001

ISO 9001 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 current revision was in 2008. 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.

The standard has a 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 text of the standard is organized into eight sections with five 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.

Basic Requirements

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 is Required
Measurement-monitoring activities are a 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.

ISO 9001: FAQ

ISO Implementation