Summary

“What fascinates me about the AI auditor is that it is very strict on one hand, and very complete on the other hand.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Eckhard Jokisch, a lead auditor with extensive experience in ISO 13485 and ISO 9001. They discuss the importance of building trust in the auditing process, the challenges of risk management in medical devices, and the innovative use of AI-based virtual auditors. Eckhard shares insights on how AI can enhance auditing efficiency while also addressing the concerns that arise from discovering more compliance issues. The conversation emphasizes the human aspect of auditing and the need for effective communication and understanding within organizations.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 Introducing Eckhard Jokisch

03:38 Building Trust as an Auditor

06:14 Understanding ISO 13485 Requirements for Risk Management

08:40 Importance of Management Responsibility in Audits

09:30 Exploring AI-Based Virtual Auditors

15:08 Balancing Findings and Concerns in Audits

18:49 Overcoming Mental Barriers with AI-assisted Audits

21:00 Announcements, Key Takeaways and Future Insights

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Suggested links:

LTR: How AI is transforming Quality in MedTech.

LTR: What we will need to lead in the age of AI.

GenieCert: Instant Audits for ISO-9001 and ISO-13485.

Key Takeaways

* Building trust is essential for effective auditing.

* AI tools can significantly enhance the auditing process.

* Risk management in ISO 13485 requires thorough documentation.

* Auditors should focus on human relationships during audits.

* Internal audits can benefit from AI-based tools.

* Finding more issues is a sign of improved scrutiny, not failure.

* Management must be involved in understanding audit findings.

* AI can help distribute workload among team members.

* Auditors need to overcome their initial distrust of automation.

* Effective communication is key to successful audits.

Keywords

Risk management, medical devices, ISO 13485, AI auditor, auditing, trust building, compliance, quality management, virtual auditor, healthcare

About Eckhard Jokisch

Eckhard Jokisch is a lead auditor for ISO 13485 and ISO 9001 compliance in MedTech. His professional experience spans over three decades in various roles ranging from software engineer, requirements analyst and manager, and Chief Technology Officer. He also served as a chartered PRRC at AuthReps.eu.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

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