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ISO/IEC 13485 - QMS for Medical Devices, Training
(Awareness and Internal Auditor)

As “Quality and Standard” are the factors considered in medical devices and equipment to maintain the safety and health at the point of use, ISO/IEC 13485 is the International standard to provide the statutory and applicable requirements. ISO/IEC 13485 is a Quality Management System for such type of organizations to demonstrate its ability to provide medical devices and related services. Training is designed for organizations who are willing to maintain quality of the devices and equipment which reflects the safety and health, as per the requirements of the ISO/IEC 13485 and needs to create awareness of implementation and audits. This training provides participants knowledge and capability needed to implement and audit Management System, and to manage a team of auditors by applying widely recognized audit principles, procedures, programs and techniques.
 

Benefits of the Training Course

  • Ability to supply Quality and Standard medical devices
  • Meet Customer expectations and regulatory requirements
  • Enhance supply chain performance and traceability
  • Maintain ISO/IEC 13485 compliance
  • Optimize implementation and auditing skills
  • Safe and healthy point of use
  • Wider market credibility
  • Demonstrated employee competence for quality and safety
  • Performing internal audits and supplier audits
  • Ability to prepare and compete the customer audits


Who should Attend

  • Medical Devices supply chain professionals
  • Process Owners
  • Functional Heads and Managers
  • System Implementers and Auditors
  • Consultants
  • Product service and development team


Course Duration (Days)
Internal AuditorLead AuditorAwareness
02 NA01
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