Endorse Organization commitment on Quality Management by effective quality management system to provide medical devices and related services.The benefits for ISO 13485 Certification are Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. Requirements for regulatory purposes sets our regulatory requirements for quality management systems for medical devices. Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. BS EN ISO 13485:2016+A11:2021 Medical devices. ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. ISO 13485 is an international standard by ISO (the International organization for Standardization) 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.
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