ISO 9002 1994 IS NOW OBSOLETE.

IT WAS REPLACED BY ISO 9001 2008.

OTHER PLAIN ENGLISH STANDARDS

ISO 9004 2009 Quality Management in Plain English

ISO 28000 Supply Chain Security in Plain English

AS9100 2009 Aerospace Quality in Plain English

OHSAS 18001 OH&S Translated into Plain English

ISO 22000 Food Safety Management in Plain English

ISO 14001 Environmental Management in Plain English

ISO 27001 Information Security Management in Plain English

ISO 27002 Information Security Management in Plain English

ISO 13485 Medical Device Quality Management in Plain English
 

ARCHIVE OF OBSOLETE ISO 9002:1994 MATERIAL

ISO 9002 Translated into Plain English

ISO 9002 is for Organizations that
Produce, Install, and Service Products

ISO 9002 is a Quality Assurance Model
made up of Quality System Requirements

ISO 9002 is a quality assurance model made up of quality system requirements. This model applies to organizations that produce, install, and service products. ISO expects organizations to apply this model, and to meet these requirements, by developing a quality system.

ISO 9002 is made up of 19 sets of quality system requirements. However, it is numbered from 4.1 to 4.20. This is because ISO 9002 retains 9001's 20 part numbering system. As you read the following material, you will notice that item 4.4 Product design is not required by ISO 9002.

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ISO 9002 4.1 - Management responsibilities

• Define a quality policy. Your policy should describe your organization's attitude towards quality.

• Define the organizational structure that you will need in order to manage your quality system.

• Define a procedure that your senior managers can use to review the effectiveness of your quality system.

ISO 9002 4.2 - Quality system requirements

• Develop a quality system and a manual that describes it.

• Develop and implement quality system procedures that are consistent with your quality policy.

• Develop quality plans which show how you intend to fulfill quality system requirements. You are expected to develop quality plans for products, processes, projects, and customer contracts.

ISO 9002 4.3 - Contract review requirements

• Develop and document procedures to coordinate the review of sales orders and customer contracts. Make sure you include the customer in the process of review.

• Your contract review procedures should ensure that all contractual requirements are acceptable before you agree to provide products or services to your customers.

• Develop procedures which specify how customer contracts are amended, and which ensure that changes in contracts are communicated throughout the organization.

• Develop a record keeping system that you can use to document the review of customer orders and contracts.

ISO 9002 4.4 - Product design (not used by ISO 9002)

ISO 9002 4.5 - Document and data control

• Develop procedures to control quality system documents and data.

• Develop procedures to review, approve, and manage all of your quality system documents and data.

• Develop procedures to control changes to documents and data.

ISO 9002 4.6 - Purchasing requirements

• Develop procedures to ensure that purchased products meet all requirements. These procedures should control the selection of subcontractors, the use of purchasing data, and the verification of purchased products.

• Develop procedures to select, evaluate, monitor, and control your subcontractors (your suppliers). Make sure that quality records are kept which chronicle the performance of all your subcontractors. Your records should identify the acceptable subcontractors and the products and services they provide.

• Develop procedures to ensure that your purchase order documents precisely describe what you want to buy.

• Develop procedures that allow you or your customers to verify the acceptability of products you have purchased.

ISO 9002 4.7 - Customer-supplied products

• Develop procedures to control products supplied to you by customers. These procedures should ensure that you:

ISO 9002 4.8 - Product identification and tracing

• Develop and document procedures to identify and track products from start to finish. When appropriate, these procedures must ensure that you:

ISO 9002 4.9 - Process control requirements

• Develop and document procedures to plan, monitor, and control your production, installation, and servicing processes.

• Design a record keeping system that monitors and controls process personnel and equipment. Make sure that all important process qualities are monitored and recorded.

ISO 9002 4.10 - Product inspection and testing

• Develop procedures to inspect, test, and verify that incoming, in-process, and final products meet all specified requirements. Also ensure that appropriate product inspection and testing records are developed, and that your procedures ensure that these records are properly maintained.
• Develop procedures which ensure that incoming products are not used until you have verified that they meet all specified requirements.
• Develop procedures which ensure that work-in-process meets all requirements before work is allowed to continue.
• Develop procedures which ensure that final products meet all requirements before they are made available for sale.
• Develop a record keeping system that your staff can use to document all product testing and inspection activities.

ISO 9002 4.11 - Control of inspection equipment

• Develop procedures to control, calibrate, and maintain inspection, measuring, and test equipment used to demonstrate that your products conform to specified requirements (the term equipment includes both hardware and software).

• Develop procedures to ensure that your measurement equipment is appropriate, effective, and secure.

• Develop procedures to calibrate all of your quality oriented inspection, measuring, and test equipment.

ISO 9002 4.12 - Inspection and test status of products

• Develop procedures to control the test status of your products. These inspection status control procedures should ensure that:

ISO 9002 4.13 - Control of nonconforming products

• Develop procedures to prevent the inappropriate use of nonconforming products. Also make sure that everyone is notified when your products do not conform to specified requirements.

• Develop procedures to control how your nonconforming products are reviewed, reworked, regraded, re-tested, recorded, and discussed.

ISO 9002 4.14 - Corrective and preventive action

• Develop procedures to correct or prevent nonconformities.

• Develop procedures to ensure that nonconformities are identified and corrected without delay.

• Develop procedures to ensure that potential nonconformities are routinely detected and prevented.

ISO 9002 4.15 - Handling, storage, and delivery

• Develop and document procedures to handle, store, package, preserve, and deliver your products.

• Develop product handling methods and procedures that prevent product damage or deterioration.

• Designate secure areas to store and protect your products.

• Develop procedures which specify how your products will be placed into storage and removed from storage.

• Develop procedures which specify how your products will be protected from damage or deterioration during storage.

• Develop procedures which specify how your products will be monitored and evaluated to detect damage or deterioration while in storage.

• Develop packing, packaging, and marking methods and procedures to protect and control the quality of products and packaging materials.

• Develop methods and procedures to protect and preserve product quality prior to delivery and while the product is still under your control.

• Develop procedures to protect your products after final testing and inspection, and during product delivery.

ISO 9002 4.16 - Control of quality records

• Identify and define the quality information that should be collected.

• Develop a quality record keeping system, and develop procedures to maintain and control it. Develop procedures to:

ISO 9002 4.17 - Internal quality audit requirements

• Develop internal quality audit procedures which:

• These procedures should also ensure that:

ISO 9002 4.18 - Training requirements

• Develop quality training procedures which ensure that:

ISO 9002 4.19 - Servicing requirements

• Develop and document quality service procedures. Your procedures should specify how:

ISO 9002 4.20 - Statistical techniques

• Select the statistical techniques that you will need in order to establish, control, and verify your process capabilities and product characteristics.

• Develop procedures to explain how your techniques should be applied.

• Develop procedures to monitor and control how techniques are used.

• Make sure that all statistical procedures are documented.

• Make sure that proper statistical records are kept.

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