Content
According to the medical device guidelines and regulations as well as DIN EN ISO 13485, medical device manufacturers are obliged to regularly verify the effectiveness of their QM system, to check their suppliers and are also audited by external organizations. During the seminar, participants will learn how internal and external audits can be planned, prepared, carried out, analyzed and used effectively. Internal audits, supplier audits and audits by third parties are compared and similarities and differences are identified.
The different types of audits as well as the requirements for the auditors and the people to be audited are presented. Preparation for external audits including the organization of a “back office” is discussed. Using case studies, you will learn how to prepare and carry out audits and how to manage conflict situations.
Topic overview
- Legal and normative requirements for internal audits and auditors
- Communication before, during and after the audit including audit behavior and ethics
- Review documents and prepare supporting documents
- Psychology of the auditee
- Conducting supplier audits
- Managing 3rd party audits
- Case studies
target group
Employees from the areas of quality management, regulatory affairs, development, production and purchasing.
Prior knowledge
Basic knowledge of DIN EN ISO 13485.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
