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:
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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
Med mere end 70.000 certifikater udstedt på verdensplan, har DNV GL i årevis været den foretrukne certificeringspartner for mange internationale organisationer samt mindre og mellemstore virksomheder.
DNV GL's lokale tilstedeværelse, globale erfaring og anerkendte faglige kompetence på tværs af brancher bidrager til et godt samarbejde med vores kunder. Vi samarbejder med vores kunder for at hjælpe dem med at skabe værdi, og til at opfylde økonomiske, sociale og miljømæssige krav og udfordringer - uanset industri, branche eller størrelse på organisationen.
Gennem vores certificering, verificering, assessments og kursus ydelser, styrker vi vores kunders organisationer, produkter, medarbejdere, faciliteter og forsyningskæder.
Vores kerneområder er:
* Certificering af ledelsessystemer - Vi har udstedt mere end 70.000 certifikater.
* Supply Chain Management
* Produktcertificering - Sikre adgang til globale markeder og mere bæredygtige produkter.
* Verifikation
* Personcertificering- Sikre og skabe tillid til individuelle kompetencer.
* Uddannelse – Inden for kvalitet, miljø, arbejdsmiljø og audit
Vores mission er at beskytte liv, ejendom og miljø, da DNV GL gerne vil bidrage til en sikker og bærerdygtig fremtid.
