ISO 13485:2016 Training Course

ISO 13485:2016 (Medical Devices Quality Management System)

ISO 13485:2016 Medical Devices Quality Management System

Requirements, Lead Auditor & Internal Auditor training courses

ISO 13485 is an international standard that specifies requirements for quality management systems for the medical device manufacturing industry. Our Extensive ISO 13485 training courses can help any organization involved in the design, production, installation, and servicing of medical devices understand and apply quality management standards.

ISO 13485:2016 Lead Auditor Course duration- 5 Days

The ISO 13485 lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures and techniques.

ISO 13485:2016 Standard requirements- 2 Days

This course will give you a detailed understanding  of Medical Devices quality management system requirements, the knowledge of ISO 13485 impacts the design, development and production of medical devices and Learn why ISO 13485 compliance is essential to meeting customer and legal requirements

ISO 13485:2016 Internal Auditor Course- 3 Days

The ISO 13485 Internal Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures and techniques.

Who Should Attend?

  • Anyone involved in the auditing, maintaining or supervising of an ISO 13485:2016 (MDQMS)
  • Management Representatives, Medical Representative, Authorized Representative
  • Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016
  • Staff responsible for conducting ISO 13485 or Quality audits
  • Candidate who are looking a career in Medical Devices quality Management, Consultants

Training Course Content

  • Understand the operations of a Medical Devices Quality Management System based on ISO 13485 standard requirements and sub clauses
  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
  • Application of auditing guidelines to ISO 13485:2016
  • An overview of the ISO 13485 requirements and Risk Assessment
  • The management systems and internal audits roles
  • The roles and responsibilities of an Internal Auditor
  • Plan your audits and how to develop the effective checklists
  • Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011 and in accordance with ISO 13485
  • Write factual audit reports that help to improve the effectiveness of the Medical Devices management system by the implementation of appropriate corrective action

Training Methodology

The preparation system incorporates lectures, practice and team coordination. The members are requested to complete group and individual activities, role playing activities, which target to build up their abilities (time administration, teamwork, participation) and assessment tests. At last, members are assessed on the consequences of their preparation and the accomplishment of the training objectives.

Why Choose ABI?

Our ISO 13485 Training program are designed by a team highly qualified and experienced medical professionals, biomedical engineers and highly experienced managements professionals in Medical Devices management system and other various ISO standards. They have handled more than 1500 training program sessions. For the usage of training classes, Recognized speaker are chosen with broad information and involvement in the field of management systems and standards. Recognizing the present patterns in the training segment.

Active Business International has made a wide system of specialist and mentors far and wide, who give an enormous state of information and involvement in the preparation area. The Training classes offered by ABI are internationally recognized and certified accredited personnel certification body. Upon fruitful completion of the composed examinations, the members will be awarded by certificate endorsed by a recognizing body.