ISO 17025 Quality Manual ISO 17025 Quality Manual Template

Thursday, May 11, 2006

 

4.6 Purchasing services and supplies

4.6.1
POLICY and PROCEDURE must be in place for selecting and purchasing services and supplies.

The purchasing procedures for reagents and lab consumable materials must include details on:
- purchase
- reception
- storage


ISO 9001:2000 Interpretation Reference clause 7.4.1
Top management of the organization must 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 organization's 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 organization's 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 supplier's 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 must 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 organization's purchasing process. This could also assist the organization in its control and availability of inventory.

The organization must define the need for records of purchased product verification, communication and response to nonconformities in order to demonstrate its own conformity to specification.

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