Training on medical devices quality systems and ISO 13485 audits are often needed to help customers and consultants write or amend documented quality systems, train internal auditors, train supplier auditors and as an introduction to new members of the quality department. All training in these areas will be based on ISO 13485:2003 Medical devices – Quality management systems. Requirements for regulatory purposes but can additionally include the quality system requirements of the appropriate national or regional regulations.

Ensuring that quality remains a priority throughout the development and production of medical devices requires not only the creation of quality management systems and associated documents but also the adherence of all staff and the supplier network to the quality management standards you introduce. SGS training in quality management for medical devices helps instill quality management procedures and standards – both those of your organization and of regulators – within your company.

The objective of our training courses range from providing an understanding of the fundamentals on standards to helping reach a professional auditor competency.

Our trainers are experts not only in the latest in training methods but also in quality management regulation developments such as ISO 13485 and ISO 9001, and other local regulations in regions such as Europe, US, Canada, Hong Kong, Taiwan, and Japan – which means they are equipped to help you meet the quality management standards expected across international markets.

SGS training programs are fully flexible, and can be tailored to fill any knowledge or skill gaps identified during an SGS gaps analysis audit prior to training. They can be delivered as public courses or in-house programs for your staff and suppliers.  However, whatever program we create for you, our aim is always to ensure that the quality of your product is not compromised by a lack an understanding of the standards that must be reached before your product is released in a specific part of the world.

SGS experts can advise on a program that meets the training needs of your current circumstances. By contracting us to conduct your quality management training, your business will benefit from the knowledge and skills that have already brought distinct business benefits to organizations across the globe.