2018 - ISO 13485:2016 – Are your suppliers ready?

OVERVIEW
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 ISO 13485 and certifications to the second edition will expire by March 2019. If you haven’t completed the transition your organization may not be able to market devices in 2019 or you may have corrective actions forced on you by your customers. This webinar will provide you with practical actions you can take to ensure your certification to this new edition of the standard is obtained.
AREAS COVERED
• Role of the organization
• Risk-based approach
• Outsourcing
• Criteria for supplier selection and monitoring
• Risk-based controls for supplier management
LEARNING OBJECTIVES
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
• Supplier Management
• Auditors
• SMEs doing the work
• Quality assurance
• Regulatory Professionals
• Biostatistics
• Data Management
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