ISO 13485:2016 Lead Auditor Training
Lead auditor training for ISO 13485:2016 — Medical Devices — delivered fully online.
Who it is for
Quality and regulatory staff at medical device manufacturers, importers and distributors, and auditors working in a regulated environment.
What the course covers
- ISO 13485 requirements, and where they diverge from ISO 9001
- Auditing design controls and the design history file where design is in scope
- Assessing risk management across the product lifecycle
- Testing traceability appropriate to device classification
- Auditing complaint handling, vigilance reporting and corrective action
- Working within documentation retention and regulatory expectations
Delivery
Delivered fully online, so your team can qualify without travel or time away from site. Course dates, duration, fees and the certification scheme that applies are confirmed on enquiry — ask us and we will send the current schedule rather than have you work from a page that may be out of date.
The standard itself
If you are weighing training against certifying your own organisation, the two usually go together: a team that has been through lead auditor training runs internal audits that hold up, and internal audits that hold up are the single most common thing missing when an organisation is found not ready at Stage 1.
ISO 13485 certification — requirements, evidence and pricing