SAHPRA inspection preparation: the records your quality system should be able to show
You have the SOP. The harder question is whether you have the record that shows it is followed. This guide is about that gap, before anyone else asks.
Last checked against its sources on 23 October 2026.
Who may look, and at what
Regulation 5(3) of the Medical Devices Regulations allows SAHPRA to inspect the business premises named in a licence application. Separately, SAHPRA requires the quality management system to be certified by an independent conformity assessment body (CAB) that it recognises, and that body audits the system against ISO 13485.
We do not know what any individual inspector or auditor will choose to look at, and nobody can promise an outcome. What both have in common is that they test claims against evidence. A procedure says what you do; a record shows that you did it.
The records worth being able to produce
| Area | Evidence that shows the procedure is followed |
|---|---|
| Document control | A current master list; approval and revision history; superseded versions withdrawn |
| Training | Training records against each role's requirements; effectiveness checks |
| Suppliers | Approved supplier list; evaluations and re-evaluations; quality agreements |
| Receiving, storage and distribution | Receiving inspection records; storage condition monitoring; delivery records |
| Traceability | Lot or serial number records from receipt to customer |
| Complaints and vigilance | Complaint files with investigation and outcome; adverse event reports made to SAHPRA, with dates |
| Nonconforming product | NC log with disposition and who authorised it |
| CAPA | Root cause, actions taken, and the effectiveness check |
| Internal audit | Audit programme; reports; findings closed |
| Management review | Minutes with the required inputs, decisions and follow-up |
The claimed-versus-evidenced gap
Most establishments are not missing whole procedures. They are missing the trail behind a few of them: a supplier list with no evaluations, a complaints procedure with no complaint files, an internal audit SOP with no audit in the last year. Those are the areas to find first, because they take the longest to fix: records can only be built forward, one cycle at a time.
Before the date
- Walk each area and ask for the record, not the procedure.
- Close overdue CAPAs or record why they are open and when they will close.
- Check that the Quality Manual's exclusions are justified in writing.
- Make sure the people who will be asked can find the records themselves.
Find your three highest-impact gaps before your next inspection.
The free Gap Heatmap: 27 questions across nine ISO 13485 areas, about 4 minutes. You get a readiness score, the gap between what you say you have and what you could show an inspector, and your biggest gaps ranked, each mapped to its clause. Free, no card.
Start my free Gap Heatmap →Sources
- Medical Devices Regulations, GN 1515, Government Gazette 40480 (9 December 2016)
- SAHPRA, ISO 13485 certificate as a prerequisite for the approval of a medical device establishment licence (MD01-2025/2026_v2, 18 September 2025)
This guide summarises published documents; it is not legal or regulatory advice. Check the source before you rely on a date or requirement.
ISO-13485 Compliance OS is software, not a regulator, notified body or certification body, and is not affiliated with or endorsed by SAHPRA. Nothing here is legal advice; no regulatory outcome is promised or guaranteed.