Medical device companies must comply with internal audit requirements of ISO 13485, but beyond regulatory compliance, internal audits are a fundamental part of implementing, maintaining and improving your quality system which is critical to your business’ success.
Deploying an internal audit program throughout your organisation will help educate personnel, confirm ownership of various quality system elements and ultimately drive continuous improvement and cost reductions.
Internal audits deliver value irrespective of how immature or mature your organisation’s quality system is.
Want to optimise and deliver more value from your internal audit program? This course can help you.
Content
You will learn and practice techniques for preparing audit plans, performing audits, verifying observations and reporting.
- Quality Auditing
- Critical role of quality audit in ISO 13484 compliance & improvement
- Regulatory standards and guidelines for quality auditing
- Risk assessment as it applies to quality audit practices
- Documents, records & data for effective audits
- Audit schedules and the use of risk management in relation to prioritising audits
- Six fundamental steps of auditing explained in detail (including tips on how to manage & facilitate audits in a constructive manner)
Participants
This course is designed for operational personnel in the medical device industry (key operators, supervisors and managers) and will assist those with a key role in quality systems implementation to develop an effective system of quality audit.
Format and Course Length
The course will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training is delivered as 2 x half-day sessions over 2 days. Breaks are included.
What Do I Need?
Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.
Sessions
This course is not currently scheduled for public delivery.
Fee and Discount
- AUD $700 (excluding GST) per participant
- A 10% discount applies for 3 or more participants from the same company
Contact us to discuss your interest in a public or private delivery of this course.
