ISO 9001 – Medical Devices Auditor Transition Training
SGS delivers efficient, practical and thorough training in order to provide accurate and current information for medical device manufacturers to meet the global regulatory, quality and technical requirements for medical devices. This allows you to place your products onto the market in the minimum time and with maximum confidence.
The Medical Devices Auditor Transition Training is designed to familiarize quality and regulatory professionals, engineers, supervisors and management with the quality system requirements under which medical devices are designed and manufactured.
The objective of this training is to inform delegates on the additional requirements of ISO 13485:2003 and their interpretation. The quality system of requirements of EC directives 93/42/EEC (medical devices) and 98/79/EC (in vitro diagnostic medical devices) are also included to allow full understanding of quality systems required to achieve CE marking.
Upon completion of this training delegates will be able to:
- Understand the requirements of ISO 13485:2003 and their interpretation
- Understand the quality system requirements of EC directives 93/42/EEC and 98/79/EC
- Prepare quality management system documentation to meet ISO 13485:2003 and EC Directives 93/42/EEC and 98/79/EC
- Use the references and guidance documents available to further enhance their understanding of quality systems for medical devices
- Undertake internal audits, supplier audits and third party audits of medical devices manufacturers
Delegates are expected to have a working knowledge ISO 9001:2008 Quality Management principles. It is also advisable to have also read the standard ISO 13485:2003.
Contact SGS today to find out more about SGS ISO 9001 to Medical Devices Auditor Transition Training.Email us
ISO 9001:2015 White Paper
ISO 9001:2015 White Paper
Helping you to better understand the contents and implications of the changes to Quality Management System requirements in ISO 9001:2015.
Medical Device Regulations White Paper
About MD market entry regulations in 13 main markets (PDF 2.55 MB)
ISO 9001:2015 Flyer (123 KB)
ISO 9001:2015 Flyer
ISO 9001:2015 positions the new version of the standard as an integral part of an organization’s efforts towards the broader aim of sustainable development and promotes it as a tool for improving an organization’s overall performance.
ISO 9001:2015 Briefing Doc (140 KB)
ISO 9001:2015 Client Briefing Document
An overview of the key changes to Quality Management Systems (QMS).
ISO 9001:2015 Presentation (543 KB)
ISO 9001:2015 Introduction Presentation
Introduction on the new version of ISO 9001.
All 13 resources