§5.5.3 looks like the easiest clause in ISO 13485 — a single short paragraph about communication. It’s also the clause most likely to make your production lead say ‘I think there’s a poster in the break room?’ when the auditor asks how the QMS is communicated.
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.
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.
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.
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.
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.
§4.2.5 requires you to control your records — identify them, protect them, store them properly, and retain them for as long as required. Records are proof. Treat them accordingly.
§4.2.4 requires you to actually control your documents — not just own them. Norma explains what that means in practice, what changed from the 2003 version, and why ‘it’s in a shared drive somewhere’ is the document control equivalent of hiding under a blanket.
The Medical Device File goes by many names — Technical File, Design History File, Device Master Record — but §4.2.3 has one clear message: for every device you make, there must be a file that proves you know what you’re doing. Norma explains what goes in it and why “it’s all in various folders” is not an answer.