content
According to the medical device guidelines and regulations as well as DIN EN ISO 13485:2016, medical device manufacturers are obliged to regularly verify the effectiveness of their QM system. Internal audits are one of the most effective tools for this. At the seminar, the participants learn how internal audits can be planned, prepared, carried out, analyzed and used effectively. The different audit forms as well as the requirements for the auditors and the persons to be audited are presented. Case studies are used to show how an internal audit is prepared and carried out and how conflict situations can be mastered.
topic overview
- Legal and normative requirements for audits and auditors
- Definition of the audit area
- Communication before the audit
- Review of documents and preparation of supporting documents
- Auditing Conduct and Ethics
- Psychology of the auditees
- Effective use of audit results
- case studies
target group
Employees from the areas of quality management, regulatory affairs, development production and purchasing.
previous knowledge
Basic knowledge of DIN EN ISO 13485.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
