DNVGL.no

ISO 13485:2016 Lead Auditor Training for Medical Device industry

Quality_Training

The QMS ISO 13485:2016 requieres 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.

ISO 13485:2016 Lead Auditor Traning for Medical Device industry

Goal:

To give a basic education to gain knowledge and by that become an auditor within medical device industry focusing on ISO 13485. To give an interactive education with full involvement of participants and practical examples with exercises. Ongoing discussions to make the education beneficial to all.

Who benefits:

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

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

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Varighet:

Duration: 1 day

Deltakeravgift:

Course fee: DKK 28.200,- (ex. VAT). The price is excluding accommodation. Course material and certificate of participation is included in the price.

Tilleggsinformasjon:

You can find our cancellation policy, terms & conditions and practical information about the course here: www.dnvgl.dk/betingelser

ISO 13485:2016 Lead Auditor Traning for Medical Device industry

Goal:

To give a basic education to gain knowledge and by that become an auditor within medical device industry focusing on ISO 13485. To give an interactive education with full involvement of participants and practical examples with exercises. Ongoing discussions to make the education beneficial to all.

Who benefits:

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

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