ISO 9001 and 9002 Requirements by Section

Prepared by Charles S. Tritt, Ph.D.
April 6, 1997

1. Management responsibility

Summary: Management must formulate the quality policy and provide the organization and resources necessary for supporting the quality system. Managers must periodically review the quality system to assess its effectiveness and suitability. There must be a management representative for ISO 9000.

Typical Tasks:

  1. Define and document a quality policy and ensure that the policy is understood and implemented by all personnel at all levels.
  2. Define and document the responsibility, authority and interrelation of key personnel concerned with the quality system.
  3. Appoint an executive manager to be the Management Representative for ISO 9000, and define his or her authority.
  4. Conduct scheduled management reviews of the quality system.

2. Quality system

Summary: The quality system must be documented in a quality manual and operational procedures. The system must be effectively implemented and maintained. There must be a quality plan for verification (inspection and testing) of products and services.

Typical Tasks:

  1. Document the outline structure of the quality system in a quality manual.
  2. Develop procedures addressing the requirements of the standard and the quality policy.
  3. Implement the documented quality system.

3. Contract review

Summary: Contracts and orders must be reviewed to ensure that the customer's requirements are adequately defined and that they have been well understood. Before accepting an order, the company must also verify that it has the capacity to meet the customer's requirements.

Typical Tasks:

  1. Review contracts and orders to ensure that customer requirements are adequately defined and resolve any misunderstandings or ambiguities.
  2. Verify the capacity to meet contract or order requirements.
  3. Define and document how amendments to contracts are made and how changes are communicated to organizations concerned.

4. Design control (only ISO 9001)

Summary: Design activities must be planned. Design input must be defined and approved. Design reviews must be conducted at important design phases. The design output must be documented, reviewed, verified and validated before release to production. There must be a system for controlling design changes.

Typical Tasks:

  1. Plan design activities, define organizational and technical interfaces and assign qualified personnel.
  2. Identify, document and review the design input.
  3. Conduct formal design reviews.
  4. Document the design output, including acceptance criteria.
  5. Review and approve design output documents before release.
  6. Verify design at appropriate stages to ensure that the design stage output meets the design stage input requirements.
  7. Validate new designs for operating conditions corresponding to intended uses.
  8. Identify, document, review and approve design changes.

5. Document and data control

Summary: Documents must be reviewed and approved before issue and be identified with a revision level. Current documents must be available at locations where they are used. Obsolete or invalid documents must be removed. All document changes and corrections must be authorized.

Typical Tasks:

  1. Review and approve documents prior to issue.
  2. Identify documents with their revision level and maintain a master list with current revision status of documents.
  3. Ensure that current documents are available at all locations where they are needed.
  4. Remove obsolete documents from points of use and identify retained historical copies of obsolete documents to preclude unintended use.
  5. Review and approve corrections in documents and reissues of revised documents.
  6. At distribution, highlight changes in revised documents.

6. Purchasing

Summary: Quality capability of suppliers and subcontractors must be evaluated. There must be a list of approved vendors. Quality performance of vendors must be continuously monitored. Purchase orders must precisely describe the ordered products and services.

Typical Tasks:

  1. Evaluate subcontractors and monitor their quality performance.
  2. Maintain a list of approved subcontractors and records evidencing their quality capabilities and performance.
  3. Precisely and completely describe the ordered product. Review and approve purchasing documents prior to release.
  4. When appropriate, verify purchased products at subcontractor's premises. Afford the same right to your customers.

7. Control of customer supplied product

Summary: This requirement is only relevant when customers supply their own products for incorporation into the final product made for them. In this case, the customer products must be verified and adequately stored. Customers must be notified in the event of loss of or damage to their products.

Typical Tasks:

  1. Verify, store, and protect products received from customers for incorporation into their supplies, and notify them in the event of loss or damage.

8. Product identification and traceability

Summary: All materials, components and products must be identified (usually by part number) during storage and all stages of production. When traceability is required, products or batches must also be identified by unique serial numbers.

Typical Tasks:

  1. Identify materials, components, and products during all stages of production.
  2. If required, uniquely identify individual products and batches to ensure traceability.

9. Process control

Summary: Production steps must be planned. For complex operations and processes, personnel must be provided with work instructions. Critical processes must be controlled. Machines, tools and equipment must be suitable and well maintained.

Typical Tasks:

  1. Plan production activities and processes.
  2. Provide personnel with work instructions and workmanship standards.
  3. Qualify, monitor and control processes, especially those the results of which cannot be verified.
  4. Use suitable production equipment and maintain the equipment to ensure continuing process capability.

10. Inspection and testing

Summary: All inspections and testing must be specified in a quality plan. Purchased products must be inspected before they are used in production. In-process inspections must be carried out when specified in the quality plan. All finished products must be inspected before they are shipped to customers.

Typical Tasks:

  1. Specify the required inspecting and testing program in quality plans and procedures.
  2. Inspect or otherwise verify received products and prevent them from being used or processed before they are accepted.
  3. Inspect products at appropriate stages of production and hold them until they pass specified in-process inspections.
  4. Inspect finished products to complete the evidence of conformance.

11. Control of measuring, inspection and test equipment

Summary: All measuring and test equipment used for inspection of products must be calibrated (or checked) and be identified with calibration stickers. Calibration certificates must be established and maintained. There must be instructions for performing complex measurements and calibrations.

Typical Tasks:

  1. Calibrate and/or check measuring and test equipment and maintain calibration records.
  2. Identify, maintain and safeguard measuring and test equipment.
  3. Define criteria for selecting appropriate measuring and test equipment with regard to accuracy, precision and environmental conditions.

12. Inspection and test status

Summary: All inspected or tested materials, components and products must be marked to indicate whether they have passed inspection, failed inspection or are on hold awaiting inspection. In addition, products that fail inspection must be segregated.

Typical Tasks:

  1. Identify inspection and test status of products to ensure that only conforming products are used or dispatched.

13. Control of nonconforming product

Summary: Nonconforming or defective products must be identified and the nonconformities (defects) must be documented. The decision regarding a nonconforming product (accept, regrade, rework, repair or scrap) must also be documented and signed by authorized personnel.

Typical Tasks:

  1. Identify, segregate and document nonconforming products.
  2. Review nonconforming product and decide if it should be accepted, regraded, reworked, repaired or scrapped.

14. Corrective and preventive action

Summary: Causes of product, process and quality system nonconformities must be investigated and corrective actions must be implemented to prevent recurrence of the nonconformities. Potential nonconformities must also be prevented. There must be a system for handling customer complaints.

Typical Tasks:

  1. Establish a system for effective handling of customer complaints.
  2. Investigate causes of product, process and quality system nonconformities and implement corrective actions.
  3. Review process and quality records to identify potential causes of nonconformities, and implement preventive actions.

15. Handling, storage, packaging, preservation and delivery

Summary: Products must be adequately handled, preserved and packaged during production, storage and delivery. Special handling, preservation and packaging techniques must be specified and personnel must be trained in their use. Deteriorated and damaged products must be removed from storage.

Typical Tasks:

  1. Provide methods of handling products that prevent damage and deterioration.
  2. Provide designated storage areas.
  3. Control receipt and dispatch of products to and from storage areas.
  4. Regularly assess the condition of products in storage.
  5. Specify and control product packaging.
  6. Apply appropriate methods of preservation and segregation of products.
  7. Protect the quality of finished products to include delivery, when specified in contract.

16. Control of quality records

Summary: All records demonstrating product conformity, process capability, personnel training and effective functioning of the quality system must be properly stored and indexed and be easily retrievable. Storage locations and retention periods of records must be documented in a procedure.

Typical Tasks:

  1. Index and organize quality records to facilitate their retrieval.
  2. Determine and document retention times for quality records.

17. Internal quality audits

Summary: All activities affecting quality must be periodically audited. Auditors must be independent from the audited activities. Audit findings must be documented and be followed up with corrective actions to deal with identified problems.

Typical Tasks:

  1. Plan and schedule internal audits of the quality management system.
  2. Conduct internal audits using independent and qualified auditors.
  3. Implement corrective actions to deal with identified deficiencies.
  4. Record and report the results of internal audits.

18. Training

Summary: Personnel must have adequate qualifications for the jobs to which they are assigned. Training needs for personnel must be identified and the required training provided. Personnel must be trained in understanding and using the quality system. A record must be kept of all training activities.

Typical Tasks:

  1. Identify training needs for all personnel.
  2. Provide for the required training and maintain training records.

19. Servicing

Summary: This section only applies to companies that provide servicing of their products. In this case, the servicing activities must be planned, organized and managed to comply with all relevant sections of the standard. Serviced products must be inspected or tested before they are shipped to customers.

Typical Tasks:

  1. Apply all relevant requirements of the standard to servicing operations and activities.

20. Statistical techniques

Summary: This section applies to companies that use statistical process control or inspect large quantities of products. In this case, there must be procedures explaining the statistical techniques used in process control and inspections.

Typical Tasks:

  1. Identify the need for and apply statistical techniques to process control and product verification.

Refereces

ISO 9000 In Our Company. Jack Kanholm. Los Angeles: AQA Co. 1994 (ISBN 1-882711-03-3)

ISO 9000 Explained (65 Requirements Checklist and Compliance Guide, 1994 Standards), 2nd ed. Jack Kanholm. Los Angeles: AQA Co. 1994 (ISBN 1-882711-06-8)

Demystifying ISO 9000. Gerard W. Paradis, Fen Small and Information Mapping Team ISO. Reading, MA: Addison-Wesley Publishing Co. 1996 (ISBN 0-201-63490-2)