ISO 13485:2016 MDQMS (MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM)
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
BENEFITS OF ISO 13485 MDQMS CERTIFICATION
The benefits of ISO 13485 certification include a demonstration of regulatory compliance and more effective risk management. Certification aids compliance with national or international regulatory requirements. Certification also confirms to customers, suppliers, and other stakeholders that the organization is in a state of control over its operations. In addition, certification:
- 1. Enables your organization to prepare for product-to-market regulatory requirements for the medical device markets of Europe, Australia, Asia, and all major developed as well as emerging markets
- 2. Provides confidence in quality risk management and good manufacturing practices within the medical device supply chain throughout the medical device product life cycle
- 3. Assures that appropriate regulatory requirement are implemented within your organizational processes
- 4. Provides confidence that best practice validation and GMP have been implemented and evaluated
- 5. organizational processes
