Surveillance audit · sample
Requests
This is what an audit looks like part-way through. The auditor raises each item they need; the manufacturer attaches what answers it and submits. Nothing moves on until the auditor has accepted it.
1 of 6 requests complete
5 outstanding · 1 awaiting the auditor’s review
- Complete · 1
- Submitted · 1
- In progress · 1
- Returned · 1
- Open · 2
17%
complete
- R-01Current ISO 13485 certificateProvide the manufacturer's current, in-date ISO 13485 certificate covering the scope under audit.1 filedue 1 AugComplete
- R-02EU Declaration of ConformityProvide the signed EU Declaration of Conformity for the products in scope.1 filedue 1 AugSubmitted
- R-03Risk management fileProvide the risk management file, including the plan, analysis and report, current to the latest release.due 8 AugIn progress
- R-04Technical documentation indexProvide an index of the technical documentation with document references and current revisions.due 8 AugOpen
Provide an index of the technical documentation with document references and current revisions.
Response · 0 files
Nothing attached yet.
Discussion
AuditorAuditor
Please provide an index of your technical documentation.
1 Jul, 09:07
- R-05Post-market surveillance procedureProvide the procedure governing post-market surveillance, including data sources and review cadence.due 15 AugOpen
- R-06Internal audit records — last 12 monthsProvide internal audit records covering the previous twelve months, including findings and closure evidence.1 filedue 15 AugReturned
Record of activity
Written by the system as things happen. Neither party can add to it, change it or remove from it.
- 7 Jul, 09:15Auditor returned R-06 Internal audit records
- 5 Jul, 14:10Manufacturer submitted a response to R-02 EU Declaration of Conformity
- 3 Jul, 08:40Auditor marked complete R-01 Current ISO 13485 certificate
- 2 Jul, 11:20Manufacturer uploaded iso-13485-certificate.pdf
- 1 Jul, 09:00Auditor raised 6 requests for this audit
Run your own the same way
Free, no account to create, and either side can start it. Your audit is private to you and the person you invite, and you can destroy it whenever you like.
Start an audit