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Session:
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4A - Uncertainty Analysis III
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Date & Time:
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Tuesday August 8, 10:45 AM - 12:15 PM
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Paper Title:
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Audits - why they aren't enough.
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Speaker:
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Harry Spinks, Calibration Services Manager
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CoAuthors:
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Speaker Info
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Company:
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Boston Scientific
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Address:
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2 Scimed Place
, MS B195 Maple Grove, MN, 55311, United States
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Phone:
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763-494-1945
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Email:
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harry.spinks@bsci.com
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Abstract:
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Organizations have many ways to evaluate or determine their ability to conform to quality requirements, whether those requirements are internally (i.e. corporate policy) or externally imposed (i.e. regulatory law, etc). One method in through audits. Calibration/metrology lab will be periodically audited to determine the level of compliance to their own quality manual (policies) and to regulatory requirements if they apply. Of particular interest are audits required by the Food and Drug Administration. The products regulated by the FDA have a direct affect on society whether they be food, medicine, or medical devices. Failure to comply with regulatory requirements could result in serious and significant harm to the public. Is it possible for a lab to pass audit after audit and still have "holes" in their quality program? Could they be compliant with their own quality policies yet fail to meet regulatory requirements? These are just some of the questions to be discussed in this paper. Case studies will be reviewed to identify why audits aren't enough and what you can do to bullet proof your quality system. This will also be of interest to auditors of calibration laboratories in evaluating their current auditing practices and determining if there are any "holes".
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