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Title: A Quality Calibration System
Author: Jay L. Bucher
Source: 2008 Measurement Science Conference
Year Published: 2008
Abstract: Whether a company is trying for registration to ISO 9000 standards, or accreditation to ISO 17025, or pushing to meet the Quality System Regulation (FDA) - they will need to have a calibration system of some sort, and it is just as easy to implement a quality system as opposed to a non-quality system. But what is a quality calibration system? The basic premise and foundation of a good quality calibration system is to Say what you do, do what you say, record what you did, check the results, and act on the difference. Within this quality system are the basics for any calibration or metrology function: calibration procedures, traceability, uncertainty, calibration records, environmental controls, out-of-tolerance procedures, etc. How much importance is placed on each of these areas is usually determined by who your customer is, and what requirements, standards, or guidelines your calibration program must meet. To this end, a quality calibration system in its basic form can set the foundation for your policies and procedures. The basics, what needs to be addresses and covered, along with a laundry list of other subjects will be presented. This paper will show how a quality calibration system within a company can be a cost effective program while meeting and/or exceeding any compliance or FDA requirements. Other companies have been doing business this way for yearsisnt it about time for everyone to be on a level playing field? You can do it, we can show you how.

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