Quality system certification, definition

Reliable chemical measurements in future will depend on more RMs with direct links to the SI as well as on RMs of greater diversity than are available now. Chemical science will be assisted by clear consensus definitions of traceability, certification, and validation, as well as by a widely accepted system for describing RMs by material composition, degree of traceability, uncertainty, quality, and purpose. Ultimately, chemists, physicists, and engineers benefit from adherence to the well-grounded and well-established discipline of metrology under a coherent system of units. 

The definition of supplier validation activities and documentation should be embedded in contractual agreements. In addition, suppfiers should agree to potential inspection by GxP regulatory agencies and Supplier Audit by pharmaceutical and healthcare companies. Supplier Audits can be conducted by the pharmaceutical or healthcare company s own personnel or, if this would compromise the supplier s commercial interests, by an independent software quality assurance auditor, consultant, or validation expert employed by the pharmaceutical or healthcare company. Auditors must be suitably qualified, for example by independent certification by examination to the quafity system standards such as ISO 9001 2000. Suppfier Audits are discussed in detail in Chapter 7. 

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