The 20 ISO 9000 quality assurance system elements

An ISO 9000 compliant quality assurance system includes up to 20 system elements documented in a pyramid of inter-connected policies, procedures and work instructions. Of the three system models (ISO 9001, 9002, and ISO 9003), ISO 9001 requires all 20 system elements. The following summary is condensed from the International Standard document ISO 9001, second edition, reference number ISO 9001:1994(E)

  1. Management responsibility:
    to define, document, and implement a policy for quality.
  2. Quality system:
    to establish, document, and maintain a quality system which includes a quality manual, system procedures, and quality planning.
  3. Contract review:
    to establish and maintain documented procedures for contract review.
  4. Design control:
    to establish and maintain documented procedures to control and verify the design of the product to ensure conformance to specified requirements.
  5. Document and data control:
    to establish and maintain documented procedures to control all documents and data (including hard copy and electronic media) including such documents as standards and customer drawings.
  6. Purchasing:
    to establish and maintain documented procedures to ensure that purchased product, associated documents and data conform to requirements. Sub-contractors are to be evaluated and selected on their ability to meet subcontract requirements and the type and extent of control exercised by the supplier over sub-contractors is to be defined.
  7. Control of customer-supplied product:
    to establish and maintain documented procedures for the control of verification, storage and maintenance of customer-supplied product provided for incorporation into the supplies or for related activities.
  8. Product identification and traceability:
    where appropriate, to establish and maintain documented procedures for identifying the product from receipt and during all stages of production, delivery and installation.
  9. Process control:
    to identify and plan the production, installation and servicing processes which directly affect quality, and to ensure these processes are carried out under controlled conditions.
  10. Inspection and testing:
    to establish and maintain documented procedures for inspection and testing activities, in order to verify that the specified requirements for the product are met.
  11. Control of inspection, measuring and test equipment:
    to establish and maintain documented procedures to control, calibrate and maintain inspection, measuring and test equipment (including test software) used by the supplier to demonstrate the conformance of product to the specified requirements.
  12. Inspection and test status:
    the inspection and test status of product shall be identified and maintained throughout the production, installation and servicing of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is dispatched, used or installed.
  13. Control of non-conforming product:
    to establish and maintain documented procedures to ensure that product that does not conform to specified requirements is prevented from un-intended use or installation.
  14. Corrective and preventive action:
    to establish and maintain documented procedures for implementing corrective action in the handling of customer complaints, product non-conformities, and the application of controls to ensure corrective action is taken and that it is effective. Preventive action procedures will detect, analyze, and eliminate potential causes of non-conformities.
  15. Handling, storage, packaging, preservation and delivery:
    to establish and maintain documented procedures to prevent damage or deterioration of product.
  16. Control of quality records:
    to establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records. Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system.
  17. Internal quality audits:
    to establish and maintain documented procedures for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.
  18. Training:
    to establish and maintain documented procedures for identifying training needs and provide for the training of all personnel performing activities affecting quality. Appropriate records of training shall be maintained.
  19. Servicing:
    where servicing is a specified requirement, to establish and maintain documented procedures for performing, verifying and reporting that the servicing meets the specified requirements.
  20. Statistical techniques:
    the supplier identify the need for statistical techniques required for establishing, controlling and verifying process capability and product characteristics, and shall establish and maintain documented procedures to implement and control their application.