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Iso 13485 Implementation Improves / Leads To: policies & Objectives Set By \'top Management\' conformance to Legal and Regulatory Requirements recognition By Regulators Around the World of Iso 13485:2003 as a Good Basis for Addressing Medical Device Design and Manufacturing Regulatory Requirements controlled Consistency of Manufactured Products managed Productivity and Efficiency, Controlling Costs competitive Advantage and Increased Marketing and Sales Opportunities. improved Customer Perception of the Organizationâs Image, Culture and Performance. improved Internal and External Communications greater Understanding of the Organization\'s Processes clear Responsibilities and Authorities Agreed for all Staff improved Use of Time and Resources reduced Wastage greater Consistency and Traceability of Products and Services.