Purpose of Training:
To introduce the practices that will determine the adequacy, suitability and effectiveness of the ISO 13485 Medical Devices Management System Standard applied within the organization; planning, implementation of internal audits, selection of auditors, etc. To give basic information on the subjects.
Content of the Training:
•ISO 13485 Medical Devices Management System Standards
•ISO 13485 Medical Devices Management System Audit
•Inspection Types and Forms
•Audit Stages and Scope
•Issues to be Considered During the Inspection
•Standards Required for Inspection
•Auditor Features
•Auditor, Lead Auditor and Audited
•Responsibilities and Activities
•Preparation and Evaluation of the Audit Question List
•Audit plan and reporting
•Nonconformance and Corrective Preventive Activities Report
•List, Report, Plan Examples
•Sample examination application
Participant Profile: Personnel who will take part in internal and external quality audits within the scope of ISO 13485 Medical Devices Management System and will be subject to inspection.
Exam: Exam can be taken at the end of the training.
Trainer: Provided by our International Chief Auditor and Training Experts. Announced Before Training.
Training Date: Announced Before Training.
Training Duration: 2 or 3 days.
Training Location: Our Company Training Halls or Announced Before the Training.
Certificate: At the end of the training, a certificate is given to those who attended the training.
Türkçe
English