ISO 13485:2016 – Are your suppliers ready?
This 1-hour session will provide the attendees with experience gained in providing transition assistance to medical device companies over the last 2 years. What constitutes a written quality agreement for outsourcing? What is the risk-based approach for supply chain management?
WHY SHOULD YOU ATTEND
All organizations that are part of the medical device supply chain are required to establish a quality management system that conforms to ISO 13485. The transition period is coming to an end for the third edition of
Role of the organization
Criteria for supplier selection and monitoring
Risk-based controls for supplier management
The transition period for this quality management system standard is coming to an end soon (February 2019). One of the key clarifications is the requirements for outsourcing as well as the selection and monitoring of suppliers. Have you prepared your supply chain for these changes? Do you expect conformance with ISO 13485 or ISO 9001?
WHO WILL BENEFIT
SMEs doing the work
For more detail please click on this below link:
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