Column: Standards Outlook: ISO 9001 and Regulatory Compliance In the Medical Device Industry

Abstract:[Abstract from article]

Lack of attention to quality systems can result in hefty fines and indirect costs for federally-regulated industries such as the medical devices industry. Regulatory considerations are identified under the ISO 9001:2000 clauses for scope and management commitment and are included as requirements for the design and development inputs of products and processes. The traditional approach used by companies for achieving regulatory compliance focuses on individual requirements and their corresponding procedures, resulting in a mountain of documentary evidence. The trouble with complex document bureaucracies has been lack of clarity for top management as to the key issues affecting quality. The solution to many of the problems faced by regulated industry involves addressing how organizations identify real and potential deficiencies to …

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good informative article

Aylin N.M.
--Aylin Nafia Minikus, 10-31-2018

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