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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 product, including quality management system-related services to such organizations.
The “ISO 17025:2018 Lead Assessor” course provides comprehensive training in Learn how to audit each and every ISO 17025: 2018 and ISO 17011 requirements Learn basic auditing skills; Implement methods to comply with the ISO 17025:2018 requirements. Auditing process and techniques