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 to 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.

The ISO 9000 documentation pyramid

The 20 quality assurance elements (or fewer elements in the case of ISO 9002 and ISO 9003), are incorporated in an interconnected documentation pyramid. The documents are indexed such that changes at one particular level do not require changes at a higher level, but may require changes at a lower level.

Level 1: the quality manual and quality system elements

At the top of the pyramid is the quality assurance manual which contains the corporate policy and statement on quality. Also included are brief statements describing how each of the applicable system elements are implemented in accordance with the company quality policy. The primary function of the 40 to 50 page quality manual is to succinctly define the company's quality assurance system to employees, management, and the ISO 9000 Registrar. It also acts as an excellent sales tool. The quality manual can be included with responses to proposals and other sales initiatives. It clearly confirms to the prospective client that they will be dealing with a quality organization which can provide goods or services in conformance with the clients specified requirements.

Level 2: quality assurance procedures

The second level of the documentation pyramid contains quality assurance procedures which describe how, when, and where the quality system element activities are conducted, along with who is responsible for conducting them. Typically, each procedure is a few pages long.

Level 3: quality assurance work instructions

The third documentation level includes the detailed instructions for the performance of the work done by the company or organization. The work instructions include design specifications, drawings, service instructions, operating procedures, process sheets etc.

Service companies and organizations

The staff effort and expense involved in creating and documenting an ISO 9000 compliant quality assurance system can be prohibitive. Service companies and organizations in particular can have difficulty in translating how they deliver their services into terms required by a quality assurance standard which was initially developed for manufacturers. However, it is possible for service companies and organizations to minimize the effort and expense involved .