Clause 6 of ISO/IEC 42001:2023 asks you to plan actions against risks and opportunities, then set measurable AI objectives and figure out how to achieve them. Art Meta walks you through what that actually means — and why AI risks are not quite like the ones you’ve been managing since ISO 27001.
ISO 13485 Clause 4.2 restructures the way medical device manufacturers think about documentation — collapsing the DMR, DHR, and DHF into the Medical Device File, and eliminating the old QSR exemption that kept your audit reports out of FDA’s hands. Here’s what that means in practice.
Clause 5 of ISO 42001 asks top management to demonstrate leadership and commitment to the AI management system. Art Meta walks through what that actually requires — policy, roles, and the fine tradition of recycled Annex SL language.
Every medical device company has a quality policy. Most couldn’t tell you what’s in it. Here’s what ISO 13485 §5.3 actually requires — and why ‘We are committed to quality and customer satisfaction’ doesn’t cut it.
Your contract manufacturer has ISO 13485 certification and a solid QMS. That’s great — and it still doesn’t satisfy your oversight obligations as the legal manufacturer. Here’s what QMSR and ISO 13485 actually require of each party when manufacturing is outsourced.
ISO 13485 §5.2 is exactly one sentence long — and it puts the weight of knowing and meeting customer and regulatory requirements squarely on top management’s shoulders. Here’s what that actually means in practice.
Welcome back. You’ve made it to Clause 4, which means you have survived the Scope (Clause 1), the Normative References
Section 820.45 is one of only two places in the entire QMSR where FDA stepped in and said ISO 13485 wasn’t sufficient. That’s worth paying attention to — especially if device labeling errors have ever appeared on your watch.
ISO 13485:2016 §5.1 requires top management to demonstrate genuine commitment to the QMS — not just sign the quality policy once a year and call it done. Here’s what that actually looks like, and why auditors can spot the difference from across the room.
Welcome back to our meticulous, clause-by-clause walkthrough of ISO/IEC 42001:2023 — the international standard for AI management systems that you’ve