To mark World Quality Week (November 7–11), SGS Academy has expanded the geographical delivery reach of its ISO 13485 Lead Auditor Training Course. This means increased availability to suit a range of time zones and regions, with interactive activities, based on industry case studies.
The flagship course provides the knowledge and skills to audit a medical devices quality management system (MD-QMS), in accordance with ISO 19011 (guidelines for auditing management systems) and ISO/IEC 17021 (conformity assessment).
To adapt to your learning style and needs, you can attend face-to-face or through virtual instructor-led training (VILT).
This five-day, CQI/IRCA-certified course helps you to:
- Explain the purpose of an MD-QMS, the interaction with appropriate medical device regulatory authority requirements, QMS standards, third-party certification and the benefits
- Understand the role and responsibilities of an auditor to plan, conduct, report and follow up a QMS audit, in accordance with ISO 19011 and ISO/IEC 17021
- Plan, conduct, report and follow up an audit to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents, in accordance with ISO 19011 and ISO/IEC 17021
A world leader in training delivery
As a leader in training delivery, we offer unrivaled experience and a global network of qualified trainers with extensive experience in the latest practices. SGS is an MDR and a CE Notified Body, a UKCA Approved Body and MDSAP Auditing Organization.
What is ISO 13485?
ISO 13485 is a globally recognized medical device certification standard to help you demonstrate that your management system meets product and regulatory requirements.
The standard specifies requirements for a quality management system (QMS) to help an organization show its ability to provide medical devices and related services that adhere to user and legal standards.
Organizations can be involved in one or more life-cycle stages, including production, storage and distribution, and installation. It can also be involved in servicing, design and development or associated activities like technical support.
The standard can be used by suppliers or external parties that provide products to organizations.
What are the key benefits?
Certification follows successful completion of an audit and enables you to:
- Produce and distribute devices faster
- Enable systematic process improvement
- Discover ways to improve efficiency and add value
- Gain a competitive advantage
- Monitor supply chains for continuous improvement
- Align with UN Sustainable Development Goals 3 and 10
Raising awareness of quality
The CQI, the only chartered body for quality professionals, hosts World Quality Week every November to raise awareness of the quality management profession.
This year’s campaign focuses on Quality Conscience: Doing the Right Thing. We are marking the event in numerous ways, including raising awareness of quality standards and examining our quality management culture.
For more information on our ISO 13485 Lead Auditor Training Course, visit ISO 13485:2016 Medical Device QMS Lead Auditor Training Course (CQI and IRCA Certified).
International Account Manager, SGS Academy
t: +34 638 56 29 69
We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.