THE TEKMERIS SEAL
Registration, calibration, maintenance or test documents are recorded as supplied. Any independent check against a register or issuing body requires an agreed scope, identified source and date.
ANNEX D · AGREED SCOPE
Production and package records: declared device identity, production batch, identified units and assigned packaging; documents presented: quality-system, registration, calibration, maintenance and test records. Receiving a calibration, safety or sterilisation document does not validate its technical conclusions. Any independent check identifies its source, date and agreed scope.
Laboratory coordination is optional. If requested, TEKMERIS instructs the factory to package and dispatch samples directly to the client's nominated laboratory under written instructions. The factory retains responsibility for packing and dispatch; TEKMERIS coordinates the agreed instructions.
TEKMERIS records observations and documents presented against the agreed scope. It does not qualify manufacturing quality systems, certify devices, grant market access or make clinical efficacy claims.
Buyers, producers and service partners may commission a premises visit, an agreed production activity for a specified batch or both, including their own premises and production batch. Select the relevant production annex and describe the requested scope in the enquiry. The agreed fee pays for the work, not a favourable finding. Acceptance is subject to lawful scope, competence, access, documentation and actual conflicts of interest.
Each assigned serial identifies covered packaging for specified production activity. Check the record and inspect the physical seal separately; a scan cannot establish its present condition. No account or login is required.
Check a Seal or BadgeACCESS CHECK - ANNEX D
The Access Check establishes whether the proposed observer visit and scope can be arranged. Describe the request below for a written quotation; agreed work starts after payment and authorisation.
TEKMERIS provides a written quotation. Payment and authorisation precede agreed access-check activity. Fees pay for the work, not a favourable finding. If the full engagement proceeds, the access-check fee is credited against it.
Refused access and any reason supplied are reported in writing; refusal alone is not wrongdoing. Independent laboratory testing is optional and separately charged.
