ISO 13485:2016 Lead Auditor Training for Medical Device industry

The QMS ISO 13485:2016 requires internal audits to be planned and performed by competent individuals. Part of this competence is audit technique and competence in the relevant standards.

This course will cover ISO 19011 and touch ISO 17021 for audit technique. For QMS audit we will cover the ISO 13485:2016 with its interface to ISO 14971 and touch other ISO standards.

About ISO 13485:2016 Lead Auditor Training for Medical Device industry

Goal:

This course will in detail go through the audit planning, performing an audit with all roles, reporting and follow-up the audit. It is expected the participants have knowledge in ISO 13485 as this is not a QMS course, but training for new auditors as well as for auditors that want to keep their competence. There will be exercises and group work within audit technique throughout the days. Even if the focus is ISO 13485 the practice can be applied for any QMS standard and other audits.

In short; to give a basic education to gain knowledge in audit technique and by that become an auditor within medical device industry focusing on ISO 13485. 

Who benefits:

Anyone who are supposed to perform audits. Usually the functions QA/RA, Supply Quality, potential internal auditors and management.

Exam:

At the end of the training there will be an exam. Certificate of successful completion/Certificate of attendance will be issued after the training.

Course Leader:

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.

Language:

Course material is in English.

Presentation in English or Swedish (depending on the participants).

Venue:

The training is held in the area of Copenhagen, Denmark