The ISO 13485 Standard Is an Effective Solution to Meet the Comprehensive Requirements for a QMS
ISO 13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series. It adapts the ISO 9000 process-based model for a regulated medical device manufacturing environment.
ISO 13485 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
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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 a product, including quality management system-related services to such organizations.
What Are the Benefits of Being Certified to ISO 13485?
Whether you are looking to operate internationally or expand locally. ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. It is the quality management system standard accepted as the basis for CE marking medical devices under European Directives.
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