| Product quality | Consistency, specifications, and suitability for the intended clinical environment | Product specifications, inspection records, test reports, and documented acceptance criteria | Compare samples and technical data with the project requirements; confirm that test results match the supplied model and configuration. |
| Quality management | Documented processes for design, production, inspection, and corrective action | Current quality-system certificates, audit summaries, and procedures relevant to the product scope | Verify certificate validity, issuing body, site, and scope. ISO 13485 applies to quality management systems for medical devices; confirm applicability to the supplier and products being assessed. |
| Patient and user safety | Risks associated with intended use, foreseeable misuse, installation, and maintenance | Risk-management documentation, safety instructions, test evidence, and post-market monitoring procedures | Check that identified risks and controls correspond to the specific product and its intended use. ISO 14971 describes risk-management processes for medical devices. |
| Electrical and mechanical safety | Electrical protection, essential performance, stability, and protection against foreseeable hazards | Applicable safety test reports, declarations, installation requirements, and maintenance instructions | For applicable medical electrical equipment, review evidence against relevant standards such as IEC 60601-1 and any applicable collateral or particular standards. |
| Biological safety | Potential biological risks when materials contact patients or users | Material information, contact-duration assessment, and relevant biological evaluation documentation | Confirm that the evaluation matches the type and duration of body contact. The ISO 10993 series provides a framework for biological evaluation of medical devices. |
| Regulatory status | Authorization, registration, or conformity requirements in the destination market | Market-specific declarations, registrations, certificates, labeling, and product identification records | Check that documentation covers the exact product, intended purpose, manufacturer, and market. Requirements differ by jurisdiction and product classification. |
| Traceability and change control | Ability to identify products and manage changes that could affect safety or performance | Lot or serial-number procedures, change-control records, and documented notification processes | Ask the supplier to demonstrate how a delivered unit can be traced to its production records and how relevant product changes are communicated. |
| Delivery and continuity | Capacity to meet project schedules and support ongoing operation | Lead-time commitments, supply-continuity plans, service arrangements, and spare-parts information | Review realistic delivery assumptions, installation and training responsibilities, warranty terms, and response arrangements for service issues. |
| Documentation and training | Availability of clear information for safe installation, use, cleaning, and maintenance | Instructions for use, technical manuals, cleaning guidance, training materials, and applicable language versions | Confirm documentation is current, suitable for the intended users, and consistent with the supplied configuration and local requirements. |