About ISO 13485:2016
ISO 13485:2016 is an international standard that specifies requirements for a quality management system specific to the medical device industry. It covers areas such as design, development, production, storage, distribution, installation, servicing, and disposal of medical devices. The Internal Auditor Program as per ISO 13485:2016 is a structured approach designed to ensure that an organization's quality management system (QMS) conforms to the requirements specified in the ISO 13485 standard.
Training Shall Broadly Cover
- Introduction to Medical Devices and ISO 13485: 2016
- Relation of ISO 9001:2015 with ISO 13485:2016
- Interpretation of all clauses of ISO 13485:2016 including key issues addressed
- Identification of applicable regulatory requirements and its compliance
- Apply principles of ISO 19011 in the auditing process
- Plan, conduct, and report effective internal audits to ISO 13485:2016
- Exercises/Workshops with real-life scenarios and case studies to make the training session interactive and more engaging
- Dedicated ‘Question and Answer’ sessions to facilitate and provide participants with the opportunity to engage actively, seek clarification, and deepen their understanding through interactive dialogue
Prerequisites
There are no formal prerequisites for attending the Training ‘Internal Auditor Program as per ISO 13485:2016’. However, it is preferred if the participant has a basic understanding of quality management principles and medical devices.
Who Should Attend?
- Quality Assurance/Quality Control Professionals
- Internal Auditors
- Process Owners and Managers
- Regulatory Affairs Personnel
- Training Coordinators
- Management Representatives
- Assessors, etc.
What’s Included?
- Learning materials
- Copy of ISO 13485: 2016 (For Training Purposes only)
- Certificate of participation (Certificate shall be issued as a ‘Soft Copy’ from our Training Portal. This certificate can be verified anytime from our website tcb.qcin.org by entering its unique ID number or scanning the QR Code)
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