Training Supplier Audits in field of Medical Devices
According to ISO 13485:2016, supplier audits are mandatory in some cases for manufacturers of medical devices. This seminar will teach you the special features of ISO 13485:2016 with regard to audit requirements. You will learn how to plan, prepare, conduct and evaluate supplier audits in accordance with ISO 19011:2018. Using practical examples from the medical device industry, you will gain confidence in conducting audits and be able to react to different audit situations. You will learn about the special features of supplier audits in the medical device industry and the requirements for a management system throughout the organization and how to classify them.
This training is also available in German under course number 4611989.
- Legal and normative framework conditions (ISO 13485:2016; special features of the standards with regard to audit requirements, EU regulations)
- Audit implementation in accordance with ISO 19011:2018
- Importance of supplier audits
- Requirements for the auditors
- Overview of the different types of audits
- Frequency and planning of supplier audits
- Practical preparation of audits
- Which areas are audited?
- Audit questions, audit process, audit documentation
- Conducting the audit (incl. introductory and final meeting)
- Communication within the audit team and audited parties
- Follow-up and evaluation of audit results
- Determination and tracking of corrective measures
- Comprehensive workshop with practical case studies and role plays
- You will learn how to successfully carry out the prescribed supplier audits in the medical device industry.
- As a medical device auditor, you will make a contribution to quality improvement through effective supplier audits.
- You will be able to ensure the required product safety of your medical devices through supplier audits.
- You will learn communication techniques for successful audits.
- Manufacturers and operators of medical devices
- Managers and specialists from the medical device industry who want to work as auditors
- Managers from strategic purchasing
- Employees from materials management/purchasing
- Internal auditors who want to expand their knowledge
- Employees from suppliers who are planning to enter the medical device industry
- Employees from the areas of Supplier Quality, Quality Assurance and Regulatory Affairs
Basic knowledge of ISO 13485
- The seminar deals with internationally valid standards and is also suitable for implementation abroad.
English
This training is also available in German under course number 4611989.
Certificate of attendance from TÜV SÜD Academy