ISO 13485:2016 Internal Auditor Training Course

Level Internal auditor Duration 2 days

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Designed by your partner in learning as an intensive course for medical device quality professionals, this ISO 13485 internal auditor training builds knowledge for an effective quality management system.

The two-day training is delivered either in person or live online in a classroom environment. Guided by experienced instructors, you will learn how to explain the structure and scope of the standard and identify an auditor’s key responsibilities. You’ll also discuss every stage of the internal audit process through role-play, workshops and tutorials, plan and conduct an audit and assess if it was done effectively.

Although some prior understanding of ISO 13485:2016 is useful, you’ll leave the course with all the knowledge you need. You’ll be able to maintain compliance and internal processes and motivate colleagues to do the same.

How will I benefit?

This course will help you:

Able to fully grasp and comply with ISO 13485:2016
Confidence that your organization is using competent auditors
Maintain rigorous internal processes
Write factual audit reports and suggest corrective actions

On completion, you should gain the knowledge and skills to:
- Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
- Identify the key principles of auditing and auditor responsibilities
- Plan an internal audit
- Conduct an effective audit based on process identification, sampling and questioning
- Determine if corrective action has been effectively implemented
Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016, as well as individuals interested in conducting first-party or second-party audits, management representatives, internal auditors and consultants.
This training course is HRD Corp claimable programme.
On completion, you will be awarded an internationally recognized BSI Training Academy certificate.
This course forms part of our auditor qualification programme. The ISO 13485 Internal Auditor Practitioner is the first step on the auditor qualification pathway to guide improvements to maintain high standards of service delivery.

On successful completion of your qualification, you’ll receive a BSI Mark of Trust that can be shared across within your organization and across your network of contacts.

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