ISO 17025 Quality Manual ISO 17025 Quality Manual Template

Thursday, February 07, 2008

 

Purchasing - 4.6.1

ISO/IEC 17025 requires that the laboratory has a policy and procedure for purchasing services and supplies that affect the quality of the tests.

Required Procedures - purchasing, receiving, and storing reagents and consumable materials must be available, so that the laboratory can clearly define requirements for the supplier. The laboratory must evaluate suppliers, and once reliability has been established, the lab can accept reports from the supplier. Purchasing documents are to be reviewed and approved for technical content prior to release. Procedures must also verify suitability of materials upon receipt. This verification may require more than one suitability test. In addition, storage and disposal procedures must exist.

Required Records - records prove that proper procedures for purchase and use of consumable materials were followed. Records provide processing history for the product as prepared solutions must be traceable to the original manufacturer's lot number. Records of the lab's evaluation and approval of suppliers must be established prior to purchase. Records include proper log into the system, as well as tests performed to establish suitability for use. Multiple records might be required for preparation of a consumable material.

Procedures for purchasing according to the ISO 17025 standard can be found at:

http://www.e-shoq.com/wst_page4.html

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