ISO 13485 Medical Device Internal Auditor
SGS Academy in Finland will organise a
ISO 13485:2016 Medical Devices Internal Auditor Training Course (2 days)
Date and location:
Feb 12th – 13th, 2019
9 am – 6 pm on both days (Registration and breakfast starting 8.40 am)
Simonkatu 9, 00100 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
This course has been prepared by the medical device specialists of SGS and the content is approved by SGS United Kingdom Ltd. SGS United Kingdom Limited is approved as Notified Body 0120, a CMDCAS Recognized Registrar, and UKAS accredited certification body 005. SGS UK Ltd is accredited under the FDA Approved Persons Program and is recognized by many other regulatory authorities including those in Australia and Taiwan. Other medical device approvals in the SGS group include SGS Japan Inc as a JPAL Registered Certification Body and SGS Hong Kong Ltd recognized by the Hong Kong Medical Device Control Office.
Robert Ross McIver, a skilled and competent Quality Systems Certification & Notified Body (Medical Devices) Consultant & Lead Auditor, with 30 years’ experience of the Medical Devices and Healthcare sectors.
The maximum number of delegates is 12. The training and all the lessons and exercises will be conducted in English. Please note that the tutor speaks British English.
To gain the most from this training, delegates will require a copy of ISO 13485 as it will be reviewed and referred to during the training. Copies of the Standard are provided for the learner’s use during this course. If participants would like to purchase their own copy of the Standard to familiarize themselves with the vocabulary and clauses,the documents are available to order here.
A 2-day-course costs 1329 € 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 Jan 21st, 2019 at the latest via the Register -button on top of this page.
General terms and conditions:
The client accepts that it is their responsibility to ensure the selected course is suitable and appropriate for participants and that they have the necessary level of competence to be able to achieve the course objectives.
SGS Fimko Ltd. can withdrawal the training 3 weeks prior if the number of delegates is less than 12. SGS Fimko Ltd. can change the lecturer and the venue. In case a delegate cancels the training at the latest 3 weeks before the agreed training date, 50% of the training fee will be charged. If delegate cancels the training later or does not cancel at all, the training fee will not be returned.
If the course is cancelled, SGS will not be obliged to reimburse any costs incurred.
For more information, please contact:
Seppo Vahasalo, Chief Technical officer, tel. +358 40 560 9500
Anne Paakkunainen, Training Coordinator, tel. + 358 43 824 9144
You can also contact us via the link below: