Section 5.5.2 is short, simple, and surprisingly easy to fumble. Name a real member of management, give them real authority, and for heaven’s sake put it in writing before the auditor asks.
Clause 7 of ISO/IEC 42001:2023 governs the unglamorous machinery of an AI management system — resources, competence, awareness, communication, and documented information. Art Meta walks through what the standard actually asks for, and why this is the clause where most implementations quietly collapse.
If everyone owns quality, nobody does. ISO 13485 §5.5.1 asks you to define, document, and communicate who is responsible for what — and yes, that means your org chart needs to be more recent than 2019.
ISO 13485 §§5.4.1 and 5.4.2 require you to turn your quality policy from a wall decoration into a measurable plan. Here’s what quality objectives actually need to look like — and why ‘improve customer satisfaction’ is not one of them.
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.
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.
Welcome back. You’ve made it to Clause 4, which means you have survived the Scope (Clause 1), the Normative References
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.