ISO 13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations. 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 such as technical support. 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 regulatory requirements.
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