ISO 13485 Internal Auditor
ISO 13485:2016 Medical Devices Internal Auditor Training Course (2 days)
Date and location:
Nov 10th – 11th, 2021
9 am – 5 pm on both days (Registration and breakfast starting 8.40 am)
SGS Fimko Oy, Takomotie 8, 00380 Helsinki
This SGS controlled course is designed to familiarize quality and regulatory professionals, engineers, designers and management with the requirements for internal auditing of ISO 13485 quality systems.
The objective of this course is to provide the skills and knowledge required to conduct internal audits as required by ISO 13485. Upon completion of this course delegates will be able to:
- Understand the requirements of ISO 13485:2016, and the quality system requirements of Directives 93/42/EEC and 98/79/EC
- Know how to conduct internal quality system audits:
- understand the role of internal audit in the maintenance and improvement of management systems
- plan and prepare for an internal audit
- learn to gather evidence by observation, questioning & sampling
- write factual reports on the compliance of the management system against the audit standards
- participate in the corrective action process
The training will be held in Finnish.
A 2-day-course costs 1190 € per delegate. Price includes course material, breakfast, lunch and afternoon snack. This training will be pre-invoiced and the payment is required before the training. VAT 24 % will be added.
Please register by Oct 26th, 2021 at the latest via the Register -button on top of this page.
For more information, please contact us via the link below: