The autoclave logbook is the document a CQC inspector reaches for first. It’s the practice’s evidence that the kit is being run properly, that test failures get noticed, and that the people operating the machine know what they’re doing. Most of the practices that score poorly on the equipment side of an inspection aren’t doing the tests wrong, they’re failing to record the tests they actually did.
This is what HTM 01-05 actually requires from a dental autoclave logbook, written so a practice manager can use it without needing to translate the source document.
The 2013 HTM 01-05 publication covers logbook requirements across several paragraphs. The most load-bearing one for retention is paragraph 4.12:
”…the code requires that these records be maintained for not less than two years, although longer periods may be applicable subject to local policy-making.”
Two years is the floor. CQC inspectors will ask for at least the last twelve months as a matter of routine; some inspectors will ask for longer. The practical position is to keep three to five years of records, which gives you cover for any inspection scenario and any clinical incident enquiry.
Paragraph 4.17 sets out what the daily-test record entry must contain:
“These outcomes should be recorded in the logbook together with the date and signature of the operator.”
So every daily test entry needs: date, the test result (pass or fail with relevant readings), and a signature from the operator who ran it. Initials are not signatures. Stamped names are not signatures. A signature is a signature.
For a typical Type B vacuum autoclave, the daily section of the logbook records:
Automatic Control Test (ACT). Confirms the cycle ran within its programmed parameters. The autoclave prints (or saves digitally) the cycle data, temperature, pressure, time at temperature. Either staple the print into the logbook or sign-off the digital record. HTM 01-05 paragraph 4.14 makes a specific point worth knowing:
“If the sterilizer has an automatic printer, the print-out should be retained or copied to a permanent record.”
Thermal-paper print-outs fade. Often within months, sometimes within weeks if they sit in sunlight. Practices that rely on the original print as their only record can find it illegible by the time an inspector asks. Either photocopy it, scan it, or transcribe the key readings into a permanent record at the time.
Steam penetration test. Bowie-Dick (porous load) or Helix (hollow load) test, run on a vacuum machine before clinical use each day. Pass or fail recorded, indicator strip ideally stapled into the logbook where the strip type allows. The longer write-up on these tests is in our Bowie-Dick and Helix practical guide.
Temperature and pressure achieved. The actual numbers from the cycle, not just “pass”, so an inspector reading back the log can see the cycle was within tolerance, not just that the machine said it was.
Operator signature. The dental nurse or other operator who actually ran the test that morning. Not the practice manager signing for everyone retrospectively.
The weekly tests catch issues the daily ACT and steam-penetration tests don’t.
Air-leakage test (vacuum machines only). The autoclave pulls a vacuum, holds, and the unit measures whether pressure rises during the hold period. Rising pressure means air is leaking back in. The pass criterion is typically a leak rate under 1.0 mm Hg per minute.
Residual-air test (Type S and N machines). Confirms the air-removal stage on non-fractionated-vacuum machines is working.
Recorded with date, result, and operator signature, same as the daily entries.
HTM 01-05 splits the testing regime by who’s qualified to perform each test:
Daily and weekly. Operator-level. The dental nurse or the practice’s designated operator.
Quarterly. Periodic tests by a Competent Person (Decontamination), usually your service engineer. Thermometric tests confirm the cycle hits target temperature within the chamber, not just at the sensor location.
Annual. Full revalidation by an accredited Test Person. Calibrated probes, full set of validation runs, written report.
All three appear in the same logbook (or paperwork pack) so an inspector can see the full year’s compliance evidence in one place.
A separate but adjacent record: the autoclave PVI certificate, issued under a Written Scheme of Examination per the Pressure Systems Safety Regulations 2000. Maximum interval between examinations is 14 months (the CQC limit). The certificate isn’t strictly part of the logbook, but it sits in the same paperwork pack and gets asked for in the same inspection question. The fuller picture is in our PVI explainer.
Worth their own section, because this is where inspectors specifically poke. If a test fails, the logbook needs to show:
The implicit question CQC inspectors are checking is: “What happens at this practice when a cycle fails?” The good answer is “we have a documented procedure, we follow it, and the logbook proves we did.” The bad answer is “we just ran it again and it was fine,” which doesn’t satisfy the documentation requirement even if the machine genuinely was fine.
HTM 01-05 paragraph 11.3 makes this stark:
“Failure to perform these tasks or retain evidence of their performance may indicate non-compliance of the decontamination process.”
A test that was done but not recorded reads to an inspector exactly the same way as a test that wasn’t done at all.
Both are acceptable. HTM 01-05 doesn’t prescribe a format. The CQC standard the inspector will apply is whether the record is:
Digital systems handle the durability problem natively but introduce a findability question, the inspector wants to see records on the day, not “after we boot up the laptop and find the right folder.” A common practical approach: digital primary record, weekly paper print-out filed in the decon room for fast inspection retrieval.
Patterns we see when practices have struggled with the equipment side of a CQC visit:
Before any CQC visit (and ideally once a quarter as a routine), open the logbook and check:
If any of those are gaps or unclear, fix them before the inspector arrives.
We provide signed service certificates, written validation reports, and PVI certificates in a single format that slots straight into your logbook. Annual visit, three certificates, consistent paperwork year on year so your inspection-ready filing is straightforward.
Ring us on 01274 265566 and tell us where you are with your logbook, whether you need a service visit, a full annual compliance bundle, or just a conversation about whether your current records would pass a CQC review.
The wider HTM 01-05 picture is in our HTM 01-05 validation explainer. The CQC-inspection angle is at the practical CQC inspection guide for practice managers.
