ISO 13485 Certification : Quality Management System(QMS) Training

We have a variety of training courses to help you to understand, implement, and audit to the new version of ISO 9001:2015, plus some more in-depth workshops. If you are just starting out on your Quality Management System journey, want to improve what you have, focus on a specific aspect of your management system, or you are an experienced practitioner looking to gain a formal qualification, SIS Certifications has a course to meet your learning objectives.

ISO 13485:2016 Internal Auditor (Medical Devices - Quality Management System Training)

This is commonly a two- or three-day course that is based on the lead auditor course above, but does not include the test for competence, so this is most useful for someone beginning to do internal audits within a company

ISO 13485:2016 Lead Auditor (Medical Devices - Quality Management System Training)

This is a four- to five-day training course focused on understanding the ISO 13485 QMS standard and being able to use it for auditing management systems against these requirements. The course includes a test at the end to verify knowledge and competence, and it is only with an accredited course that an individual can become approved to audit for a certification body.

ISO 13485:2016 - Awareness (Medical Devices - Quality Management System Training) Course

Several courses are offered that provide knowledge of ISO 13485 and how to implement it. These can be one- or two-day courses, and they can even include online e-learning sessions as a method of teaching the material. These courses are good for those who need an overview of the ISO 13485 standard, or those who will be involved in the implementation within a company, and many are more economical than investing in the lead auditor course for those involved at this level.