The CQC inspector is coming. Maybe you know the date, maybe it’s a notice you got this morning. Either way, the part of the inspection that catches dental practices out most often isn’t the kit itself, it’s the paperwork. Most practices have working autoclaves and competent operators. Fewer have the documentation trail that lets a CQC inspector tick all the boxes in twenty minutes and move on.
This is what an inspector actually wants to see for decontamination, where in your filing system it should live, and the documentation gaps that turn a routine visit into a finding.
CQC inspections of dental practices apply the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. Two regulations bear directly on autoclave and decontamination evidence:
Regulation 15, Premises and Equipment. The verbatim wording from CQC’s guidance:
“All premises and equipment used by the service provider must be, (a) clean, (b) secure, (c) suitable for the purpose for which they are being used, (d) properly used (e) properly maintained, and (f) appropriately located for the purpose for which they are being used.”
Your autoclave is the equipment in question. Every adjective in that list needs evidence behind it.
Regulation 12: Safe care and treatment. Covers the safety of how care is delivered. Failed sterilisation is a Regulation 12 risk, not just a maintenance issue.
The companion CQC document is Dental Mythbuster 12, Validation of decontamination equipment, which sets out specifically what inspectors look for on dental decontamination. The maximum interval between PVI inspections is 14 months, Mythbuster 12 states this explicitly.
A complete inspection-ready decontamination file has the following. Have all of these accessible within two minutes, if the inspector has to wait while you hunt, the impression is the practice doesn’t routinely use this paperwork, even if everything is technically present.
Annual HTM 01-05 validation report. Issued within the last 12 months. Calibrated probe runs across the validation load configurations, written report with parameters versus tolerances, engineer signature.
Current Pressure Vessel Inspection certificate. Statutory under the Pressure Systems Safety Regulations 2000. Issued within the last 14 months (the CQC maximum). Written Scheme of Examination available alongside if the inspector asks.
Annual service certificate. Manufacturer-spec preventive maintenance pass, completed within the last 12 months, engineer signature.
Daily and weekly test logbook. Operator-level checks. Daily Automatic Control Test, daily Bowie-Dick or Helix steam-penetration test (vacuum machines), weekly air-leakage test. Each entry needs date, result and operator signature. Records retained for at least two years per HTM 01-05 paragraph 4.12.
Decontamination policy or SOP. A written document describing how your practice decontaminates instruments, who’s competent to do it, how cycles are tested, what happens if a cycle fails. One to three pages is plenty if the substance is right.
Training records. For each operator who runs the autoclave or carries out decontamination tasks. Date trained, what they were trained on, evidence of competence (signed assessment), and refresher schedule.
Risk assessments. General clinical-safety risk assessments including decontamination-related risks. COSHH assessments for any chemicals used in instrument cleaning.
Water-quality records. If your autoclave runs on an RO system, conductivity readings at service intervals. If on bottled distilled water, the supply records.
Failure response evidence. If any test has failed in the last 12 months, the records of what was found, what was done about it, and the test that passed afterwards.
Mythbuster 12 effectively asks one structural question of every dental practice: “What happens at this practice when a cycle fails?”
The answer needs three components:
A practice that’s never had a fail recorded in the last year reads to an inspector as either miraculously perfect or genuinely failing-without-recording. Genuinely perfect happens occasionally; failing-without-recording happens more often. The inspector is checking which one you are.
If you’ve genuinely had no fails, that’s fine, but your written procedure still needs to exist and your operators still need to know it. A common follow-up question is “show me your written cycle-failure procedure” and “talk me through what you’d do if today’s Bowie-Dick failed.”
Regulation 15(1)(e): “properly maintained.” The inspector will read that against:
Service intervals matching manufacturer recommendations. For most UK-installed dental autoclaves, annual service is the manufacturer standard. Cassette-style units may need a six-month consumables check on top of the annual visit. Mythbuster 12 expects the schedule to follow the IFU.
Validation within HTM 01-05’s annual cycle. Paragraph 12.2 of HTM 01-05 mandates annual validation. Letting that lapse beyond 12 months is a Regulation 15 risk regardless of whether the machine seems to be running fine.
PVI within the 14-month maximum. Statutory ceiling under PSSR 2000. Don’t drift past it.
Repair history documented. Every engineer visit logged, parts replaced recorded, follow-up validation evidenced where the repair was significant.
Patterns we see in practices that score lower on the equipment side of an inspection:
Logbook gaps from staff changes. The nurse who normally signs the daily test went on leave, no one covered the test for a week, the logbook has blank entries. Easy to spot.
Initials instead of signatures. HTM 01-05 paragraph 4.17 specifies the operator’s signature. A column of identical initials doesn’t satisfy this.
Faded print-outs. Thermal-paper autoclave prints from six months ago that are now illegible. Paragraph 4.14 expects either retention or transfer to a permanent record.
Service certificate exists but doesn’t reference the autoclave’s serial number. Inspectors check the cert matches the unit in the decon room. A generic “annual service done” certificate isn’t enough.
No PVI Written Scheme of Examination. Practices have the PVI certificate but not the underlying Written Scheme. Both are statutory.
Training records for the wrong people. The dentist’s CPD is filed but the dental nurse who actually runs the autoclave has no training records.
Decontamination policy that’s a generic template. Untouched from when it was downloaded, no practice-specific detail, no signature or date.
Risk assessments dated 2020. Or undated. Or signed by someone who’s left the practice.
Worth doing the week before any expected inspection and ideally as a routine quarterly check. Go through every item on the list above. For each:
Anything that fails any of those four checks gets fixed before the inspector arrives.
For the autoclave-side paperwork, our annual service bundle issues all three certificates, service, validation and PVI, in a consistent format that slots into the inspection file. Same engineer year on year, same paperwork format, all dated together so the cycle is easy to track.
For decontamination policy and training records, those are practice-internal documents, we can suggest the structure but the practice has to own the content. We’ll be glad to look at a draft if you’d like a sanity check on whether it covers what an inspector will ask about.
Ring us on 01274 265566 and tell us what stage you’re at, whether you’ve got a known inspection date coming up, whether you’ve just been served notice, or whether you’d like to use a quiet month to get the paperwork in order before the next routine visit.
The wider compliance picture sits in our HTM 01-05 validation explainer and our CQC inspection guide for practice managers. The logbook-specific detail is at autoclave logbook requirements.
