The company formulates the Procedures for the Control and Management of Instrument and Equipment, and the laboratory should be equipped with equipment necessary for the correct development of laboratory activities and that can affect the results, including but not limited to: testing instruments, software, testing standards, reference materials, reference data, reagents, consumables or auxiliary devices.
Note 1: Reference materials and certified reference materials have many names, including standard samples, reference standards, calibration standards, standard reference materials and quality control materials. The reference materials provided by the manufacturer of labeled substances that meets the requirements of ISO17034 will have a product information sheet/certificate, which contains at least the uniformity and stability of the specified characteristics in addition to other characteristics. For certified reference materials, the information contains the standard values of the specified characteristics. For related measurement uncertainty and measurement traceability, use the reference materials provided by the manufacturer that meets ISO17034.
Note 2: ISO Guide 33 gives guidelines for the selection and use of reference materials. ISO Guide 80 gives guidelines for the internal preparation of quality control substances.
When the laboratory uses equipment other than laboratory testing, it shall ensure that the equipment requirements of the standard are met.
The laboratory should have procedures for handling, transporting, storing, using and maintaining equipment as planned to ensure the normal operation of equipment functions and prevent pollution or performance degradation.
The equipment used for measurement should be able to achieve the required measurement accuracy or uncertainty in order to provide effective results.