Organizational Management System

Organizational
Management System

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ISO 13485: Medical Devices Quality Management System

The Medical Device Quality Management System | BASE PLUS is a foundational product that contains core procedures for companies engaged in the design and manufacture of medical devices. Additional procedures can be easily added as needed. A perfect starter package for those who desire the minimum required content to obtain ISO 13485:2016 certification and FDA QSR …

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ISO 9001: Quality Management System

The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved. SECTOR-SPECIFIC APPLICATIONS OF ISO 9001 ISO has a range of …

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