The nine ISO 13485 areas on one page

The problem: Uncontrolled documents in circulation. The SOPs usually exist; nobody can prove which copy is live.

Test it this week: Walk to one point of use, such as the receiving desk. Compare the printed copies with your master document list and mark every mismatch.

The problem: Review inputs with no trend data. A list of what happened is not a trend.

Test it this week: Count complaints by month for the last 12 months. Put the last 6 months next to the 6 before. That is your first trend.

The problem: A risk file not updated post-market. It was finished the day it was written, and complaints never fed back into it.

Test it this week: Take your highest-volume product family. Match each complaint and return from the last 12 months to a hazard in its risk file, and mark any with no hazard as new.

The problem: Supplier re-evaluation records incomplete. You checked your suppliers once, and cannot show they still pass.

Test it this week: List every supplier you paid in the last 90 days, couriers and calibration included. Mark anyone who is not on your approved-supplier list.

The problem: No documented CAPA effectiveness checks. The CAPA is closed, but nothing shows the problem went away.

Test it this week: List every CAPA closed in the last 12 months. Mark which records hold a written effectiveness check, with a date and a name.

The problem: An audit programme that is not risk-based. Every process is audited once a year, whatever its risk.

Test it this week: Score each process high, medium or low risk, using last year's complaints, CAPAs and findings. Book the next audit for the highest-risk one, with an auditor who does not run it.

The problem: Nobody has written down how clause 7.3 applies to what you actually do, so the design question has no answer on paper.

Test it this week: List anything you change yourself, such as labels, kits, packaging, instructions or software settings. Mark each one "no design impact" or "needs a closer look".

The problem: You cannot say quickly which customers received a given lot.

Test it this week: Pick one lot you received in the last 6 months. Using only your records, list every customer who got it, with quantities and dates. Time yourself.

The problem: The work was done, but the record cannot be found.

Test it this week: Find 5 records: a supplier evaluation from 2 years ago, a training record for your newest staff member, last year's management review minutes, a closed CAPA and a delivery note for one lot. Time each search.