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© ISO 2000 – All rights reserved
Participation by the affected parties permits the actual users to evaluate the output by such means as — validation of engineering designs prior to construction, installation or application,
— validation of software outputs prior to installation or use, and — validation of services prior to widespread introduction.
Partial validation of the design and development outputs may be necessary to provide confidence in their future application.
Sufficient data should be generated through verification and validation activities to enable design and development methods and decisions to be reviewed. The review of methods should include
— process and product improvement, — usability of output,
— adequacy of process and review records, — failure investigation activities, and
— future design and development process needs.
ISO 9001:2000, Quality management systems — Requirements 7.3.4 Design and development review
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements
a to evaluate the ability of the results of design and development to meet requirements, and b to identify any problems and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with the design and development stages being reviewed. Records of the results of the reviews and any necessary actions shall be maintained.
7.3.5 Design and development verification
Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the
verification and any necessary actions shall be maintained.
7.3.6 Design and development validation
Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, when known.
Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained.
7.3.7 Control of design and development changes
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development
changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
Records of the results of the review of changes and any necessary actions shall be maintained.
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© ISO 2000 – All rights reserved
29 7.4 Purchasing
7.4.1 Purchasing process
Top management of the organization should ensure that effective and efficient purchasing processes are defined and implemented for the evaluation and control of purchased products, in order that purchased products satisfy the
organizations needs and requirements, as well as those of interested parties.
Use of electronic linkage with suppliers should be considered in order to optimize communication of requirements. To ensure the effective and efficient performance of the organization, management should ensure that purchasing
processes consider the following activities: — timely, effective and accurate identification of needs and purchased product specifications;
— evaluation of the cost of purchased product, taking account of product performance, price and delivery; — the organizations need and criteria for verifying purchased products;
— unique supplier processes; — consideration of contract administration, for both supplier and partner arrangements;
— warranty replacement for nonconforming purchased products; — logistic requirements;
— product identification and traceability; — preservation of product;
— documentation, including records; — control of purchased product which deviates from requirements;
— access to suppliers premises; — product delivery, installation or application history;
— supplier development; — identification and mitigation of risks associated with the purchased product.
Requirements for suppliers processes and product specifications should be developed with suppliers in order to benefit from available supplier knowledge. The organization could also involve suppliers in the purchasing process in
relation to their products in order to improve the effectiveness and efficiency of the organizations purchasing process. This could also assist the organization in its control and availability of inventory.
The organization should define the need for records of purchased product verification, communication and response to nonconformities in order to demonstrate its own conformity to specification.
7.4.2 Supplier control process
