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ISO 9001 Requirements

The International Organization of Standards (ISO) is the world's largest developer of standards. Founded in Geneva in 1947, ISO is comprised of members from both the public and private sectors in over 150 countries. ISO standards have historically focused on the manufacturing of products, standardizing everything from the thickness of an ATM card to the number of threads on a screw, but have in recent years evolved into the development of quality management standards. ISO standards are not only concerned with the product or service but also with the process by which that product is produced or that service delivered.

The family of ISO 9000 Standards is the result of a synthesis of "best practices" in quality management. Like all ISO standards, the 9000 family was developed around the idea that standardization creates an atmosphere of transparency, accountability, and cooperation. Standardization in business process allows everyone involved to stay on the same page. It maximizes efficiency while exposing weak areas in the process. It allows organizations to develop clear, attainable goals. The principles themselves are designed to increase patient satisfaction and operate under the assumption that improvement is always possible.

ISO 9001 requirements are based on eight management principles:

  1. Customer focus

  2. Leadership

  3. Involvement of people

  4. Process approach

  5. System approach to management

  6. Continual improvement

  7. Factual approach to decision making

  8. Mutually beneficial supplier relationships

A quality management system is developed by

  • Documenting what is done

  • Establishing a process for the service

  • Performing to the documentation

  • Providing the service based on the process

  • Recording the results of the work performed

  • Appropriately maintaining all recorded information

  • Auditing the documentation for effectiveness

  • Auditing using the process approach

Documentation and maintenance of records create transparency within the organization. A commitment to performing to the documentation and providing the services described by the process create an atmosphere of accountability. Auditing enforces that accountability. Overall, cooperation both within an organization and with other organizations within the field ensures the constant improvement of process.