Internal auditor in the medical device industry
Description:
Internal audits are not only required by standards; in practice, they also represent an indispensable tool for reviewing and improving company processes. Effective internal audits can make huge contributions to the optimisation and further development of processes. This requires highly educated auditors who work methodically and thoroughly to verify compliance with the fundamentals set out in standards and laws, which is required in the medical device industry, and who should also be able to go further, advancing the company's processes using analysis and identification of potential improvements.
Contact Person:
Goals
This seminar explains the principles and methods involved in planning and performing internal audits, in particular the specific requirements set out in EN ISO 13485. It covers the specialist principles behind performing an internal audit, and offers participants the chance to develop their dialogue and behaviour skills in workshops. This seminar is specifically tailored for the medical device industry and should equip auditors to perform accurate, complete analyses of processes.
Seminar content
Principles of internal auditing:
- Internal audits, theoretical principles
- Audit techniques
- Audit planning, audit performance in practice, audit follow-up
Interpretation of EN ISO 13485
Essential requirements set out in EN ISO 13485 are explained in more detail. In collaboration with the participants, the aspects of internal audits that must specifically be considered in the medical technology sector are determined. Key topics include:
- Development and technical documentation
- Manufacturing under particular environmental conditions (cleanrooms)
- Validation and routine monitoring of sterilisation
- Specific processes in manufacturing
- Traceability
- Complaint management and customer feedback, legally required processes for vigilance and post-market surveillance
Workshop topics:
- Applying the set of audit documents
- Audit planning
- Audit performance role-play
- Assessing audit results
Target group / seminar duration and certificate
This seminar is designed for internal auditors and for employees in quality management or quality assurance.
The content is presented over two days, including workshops where participants can apply their knowledge. Following the seminar, participants then take a test to check their knowledge. You will receive an "Internal Auditor" certificate and, on request, materials for participants in physical or digital form.
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