In this two day internal auditor training course you will learn the principles and practices of effective quality management process audits in accordance with ISO 13485:2016 and ISO 19011:2018. You will be taken through the entire audit process from planning the audit to reporting and follow up on non-conformities.
About ISO 13485:2016 Internal Auditor Course
Content:
• ISO 19011:2018 introduction
• ISO 13485:2016 introduction and focus on checklists each chapter one day
• How to plan and conduct effective audits for ISO 13485 including preparation of checklists
• Workshop on Preparation of checklists and presentation
Who should attend:
The training is for all individuals and organizations who need to perform internal or external audits (supplier audits) within a medical device life-cycle based on ISO 13485:2016.
You will learn how to plan and perform audits, how to use the ISO 13485 to prepare checklists and how to report the audit.
What will you learn:
• Have an understanding of ISO 19011 and its benefits
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• Have an understanding of the principles and the benefits of ISO 13485 auditing
• Have obtained the skills necessary to plan and conduct audits based on ISO 13485
• Be able to plan, prepare, conduct and report on internal audits against ISO 13485
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. Anette is also a member of the new task force for Annex L (high level structure).
Language:
The training is held in English.
%%%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.
