About ISO 13485:2016
To give an understanding of the full standard. You should be qualified as internal auditor in ISO 13485 after the course.
Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force. Anette is also a member of the new task force for Annex L (high level structure).
Course material is in English.
Presentation in English or Swedish (depending on the participants).
Two days course including a written examination (multiple choice questions)
Background and introduction to ISO 13485
The chapters 4 – 7.2 with exercises and workshops within policy, objectives and competence profiles. Examples to illustrate industry practice. Practical guide information throughout and reference to other guidance documents.
Continue chapter 7 and 8 with workshops within the CAPA process. Examples to illustrate industry practice. Practical guide information throughout and reference to other guidance documents.