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Quality Management Systems demonstrate that organizations have clear and definite processes that can provide the service they offer with quality and control. Meeting clients' expectations, having lean and adequate organizational processes, competitive costs and prices, quality assurance and recognition, routine record and consistent information for decision making are key factors for achieving success in any organization. If you believe that those factors are vital and you are anxious to develop them in your organization, be aware that Quality Management Systems can help you achieve and maintain those standards through ISO Certification.
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What is ISO?
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The Resolution RDC 59 approved on June 27, 2000 is a set of mandatory requirements imposed by ANVISA* (Agência Nacional de Vigilância Sanitária Nacionanl / Nacional) for manufacturers and distributors of medical and dental products. Meeting RDC 59 requirements also known as (GMP) Good Manufacturing Practice or (GDP) Good Distribution Practice is compulsory.
RDC 59 is based on the requirements imposed by FDA in the United States of America (USA) where it is known as Good Manufacturing Practices (GMP). Therefore we can better define GMP as a Quality Management System specially created for manufacturers and distributors of medical and dental equipments.
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Get more information about GMP/RDC 59
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