[Clinic name]
Controlled document
[Address]
[Registration or licence number]
MHLW inspection checklist
1Opening and notifications
- Confirm whether the clinic files a 開設届 or needs a 開設許可 first.
- Consult the 保健所 with floor plans before building work starts.
- File the 開設届 within 10 days of opening, and a 廃止届 within 10 days of closing.
- Check whether the site sits in a designated 外来医師過多区域.
2People
- A 管理者 who has completed clinical training, managing this clinic only.
- Every doctor's and nurse's licence on file, matching the notification.
- The 管理者, the doctors and their hours posted inside the clinic.
- Accounts of leavers closed on the day they leave.
3The 診療録
- Every consultation written up without delay, by the doctor who saw the patient.
- Each 診療録 kept 5 years, with electronic entries authentic, readable and preserved.
- Patients can ask for disclosure, with a reasonable fee if any.
- The 利用目的 posted in the clinic and on its website.
4Safety and security
- A written safety guideline, staff training and an incident reporting route.
- Infection control, a medicines safety lead and medical device checks.
- The FY2026 cybersecurity checklist answered, with target dates for every no.
- An incident contact chart naming the vendor, MHLW and the police.
5What an MHLW inspector may ask
- Who is the 管理者, and do they manage only this clinic? What to show, the 管理者's licence and clinical training certificate, matching the 開設届.
- Show me the 診療録 for these patients. What to show, a record written without delay, with every entry's author and time, kept for 5 years.
- Which doctors and nurses work here? What to show, the staff list, the licences and the posted hours.
- How are incidents reported and acted on? What to show, the safety guideline, the incident reports and the improvement taken.
- Where is the cybersecurity checklist, and who do you call in an incident? What to show, the FY2026 checklist filled in, and the incident contact chart.
- Where are your patients' records stored? What to show, where the servers sit, which law applies, and the notice patients see.
- How do you use AI in care? What to show, where AI is used, and who decides.
AAppendix, Monthly readiness check
- A.1Month ______ Checked by ______
- A.2開設届 still accurate ______ Changes notified on ______
- A.3診療録 read ______ Gaps found ______
- A.4Incidents reviewed ______ Improvements shared on ______
- A.5Cybersecurity checklist items open ______ Target dates ______
- A.6Actions, owner and date ______