ISO 9000 Requirements Summary

This is a summary of principle requirements of ISO 9000. Use it to explain to managers and others what ISO requires and why. Most of these requirements are just common sense, and yet, many organizations fail to use that common sense. 

• The quality policy shall be defined, documented, understood, implemented and maintained.

• Responsibilities and authorities for all personnel specifying, achieving and monitoring quality shall be defined.

• In-house verification resources shall be defined, trained and funded.

• A designated management person sees that the Q91 program is implemented and maintained.

• Procedures shall be prepared.

• Procedures shall be implemented.

• Incoming contracts (and purchase orders) shall be reviewed to see whether the requirements are adequately defined, agree with the bid and can be supplied.

• The design project shall be planned.

• Design input parameters shall be defined.

• Design output, including crucial product characteristics shall be documented.

• Design output shall be verified to meet input requirements.

• Design changes shall be controlled.

• Generation of documents shall be controlled.

• Distribution of documents shall be controlled.

• Changes to documents shall be controlled.

• Potential subcontractors and sub-suppliers shall be evaluated for their ability to provide stated requirements.

• Requirements shall be clearly defined in contracting data.

• Effectiveness of the subcontractor's quality assurance system shall be assessed.

• Any customer-supplied material shall be protected against loss or damage.

• The products shall be identified and traceable by item, batch or lot during all stages of production, delivery and installation.

• Production (and installation) processes shall be defined and planned.

• Production shall be carried out under controlled conditions: documented instructions, in-process controls, approval of processes and equipment, and criteria for workmanship.

• Special processes that cannot be verified after the fact shall be monitored and controlled throughout the processes.

• Incoming materials shall be inspected or verified before use.

• In-process inspection and testing shall be performed.

• Final inspection and testing shall be performed prior to release of finished product.

• Records of inspection and test shall be kept.

• Equipment used to demonstrate conformance shall be controlled, calibrated and maintained.

  Identify measurements to be made.

  Identify affected instruments.

  Calibrate instruments (procedures and status indicators).

  Periodically check calibration.

  Assess measurement validity if found out of calibration.

  Control environmental conditions in metrology lab.

• Measurement uncertainty and equipment capability shall be known.

• Where test hardware or software is used, it shall be checked before use and rechecked during use.

• Status of inspections and tests shall be maintained for items as they progress through various processing steps.

• Records shall show who released conforming product.

• Nonconforming product shall be controlled to prevent inadvertent use or installation.

• Review and disposition of nonconforming product shall be formalized.

• Problem causes shall be identified.

• Specific problems and their causes shall be corrected.

• Effectiveness of corrective actions shall be assessed.

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• Procedures for handling, storage, packaging and delivery shall be developed & maintained.

• Handling controls shall prevent damage and deterioration.

• Secure storage shall be provided. Product in stock shall be checked for deterioration.

• Packing, preservation and marking processes shall be controlled.

• Quality of the product after final inspection shall be maintained. This might include delivery controls.

• Quality records shall be identified, collected, indexed, filed, stored, maintained and dispositioned.

• Audits shall be planned and performed.

• Results of audits shall be communicated to management.

• Any deficiencies found shall be corrected.

• Servicing activities shall be performed to written procedures.

• Servicing activities shall meet requirements.

• Statistical techniques shall be identified.

• Statistical techniques shall be used to verify acceptability of process capability and product characteristics.