Item ID,Review area,Review question,Requested evidence,Evidence reference,Reviewer,Review date,Finding or status,Follow-up action,Action owner,Target date
ID-01,Supplier identity,Are manufacturer and contracting seller identified?,Legal names and registered addresses,,,,,,,
ID-02,Supplier identity,Is the relationship between seller and manufacturer documented?,Relationship or authorisation documentation where applicable,,,,,,,
ID-03,Supplier identity,Is the production site for the offered model identified?,Site address and production responsibility,,,,,,,
REG-01,Market requirements,Are destination and intended use recorded?,Destination requirements assessment,,,,,,,
REG-02,Market requirements,Are device classification and applicable obligations established?,Classification rationale reviewed for the destination,,,,,,,
REG-03,Quality management,Does the quality certificate cover the relevant entity and site?,Current certificate and issuer verification,,,,,,,
REG-04,EU documentation,Is the applicable EU conformity route documented if relevant?,Model-specific declaration and supporting assessment,,,,,,,
REG-05,EU documentation,Is notified-body involvement verified where required?,Body designation and relevant scope,,,,,,,
REG-06,Product testing,Are applicable standards and accepted editions established?,Destination acceptance and transition assessment,,,,,,,
REG-07,Product testing,Do reports cover the offered model and complete configuration?,Reports with model details and tested mattress or accessory configuration,,,,,,,
REG-08,US documentation,Is a clearance or exemption assessment provided if US-bound?,Product code and applicable 510(k) route including exemption limitations,,,,,,,
REG-09,US documentation,Are applicable FDA registration and listing records verified?,Current database records without treating registration as approval,,,,,,,
AUD-01,Factory audit,Are drawings and component specifications controlled?,Document-control records and sample bill of materials,,,,,,,
AUD-02,Factory audit,Can parts and finished units be traced?,Traceability demonstration with identified sample records,,,,,,,
AUD-03,Factory audit,Are purchased and subcontracted items controlled?,Supplier qualification and incoming acceptance records,,,,,,,
AUD-04,Factory audit,Are inspection instruments and equipment controlled?,Calibration and maintenance records,,,,,,,
AUD-05,Factory audit,Are nonconforming products controlled and issues resolved?,Nonconformity and corrective-action examples,,,,,,,
SAM-01,Sample approval,Does the sample match the proposed production configuration?,Sample identification and signed configuration,,,,,,,
SAM-02,Sample approval,Have clinical and cleaning workflows been reviewed?,User review and cleaning compatibility record,,,,,,,
SAM-03,Sample approval,Are mattresses and accessories explicitly matched to the bed?,Approved component list and compatibility evidence,,,,,,,
SAM-04,Sample approval,Are unresolved sample deviations documented?,Deviation list and agreed corrective actions,,,,,,,
OEM-01,OEM change control,Are branding and engineering changes distinguished?,Approved artwork and product-change schedule,,,,,,,
OEM-02,OEM change control,Are legal roles and documentation responsibilities clear?,Responsibility agreement for the destination market,,,,,,,
OEM-03,OEM change control,Must substitutions and revisions receive written approval?,Contractual change-control procedure,,,,,,,
SHP-01,Pre-shipment inspection,Are inspection scope and defect handling agreed?,Inspection plan with escalation and release criteria,,,,,,,
SHP-02,Pre-shipment inspection,Are production units consistent with the approved configuration?,Inspection report and production-release evidence,,,,,,,
SHP-03,Pre-shipment inspection,Are shipment quantities and packaging checked?,Packing list and package inspection record,,,,,,,
SHP-04,Pre-shipment inspection,Are material findings resolved before release?,Corrective-action evidence and authorised release,,,,,,,
SRV-01,Service,Are replacement parts identified and orderable?,Parts list with references and ordering process,,,,,,,
SRV-02,Service,Are warranty costs and responsibilities explicit?,Written terms for parts labour freight and site work,,,,,,,
SRV-03,Service,Are manuals and permitted service procedures available?,Model-specific instructions and authorised service scope,,,,,,,
SRV-04,Commissioning,Are assembly training and handover responsibilities assigned?,Commissioning plan and acceptance checklist,,,,,,,
COM-01,Commercial comparison,Is the complete delivered scope priced?,Itemised offer with exclusions and optional items,,,,,,,
COM-02,Commercial comparison,Are shipping scope and quotation validity clear?,Named trade term location version and validity period,,,,,,,