| ISO 13485:2016 certification | Whether the quality-management-system certificate is current and covers the relevant legal entity and manufacturing site. | Certificate copy showing certificate number, issuing certification body, site address, scope, issue date, and expiry date. | Confirm the certificate’s status with the issuing certification body. ISO 13485 certification applies to a quality-management system; it is not product approval. |
| Certificate scope and site coverage | Whether the stated scope and covered location match the activities relevant to the bandages being purchased. | Certificate scope, site list or annex, and confirmation of which site performs manufacturing, packaging, and any outsourced processes. | Check the actual certificate wording rather than relying only on a general claim of being “ISO certified.” |
| Product configuration | Bandage dimensions, backing material, adhesive type, absorbent pad, intended use, and available variants. | Product specification, labeling, packaging details, and samples representative of the quoted product. | Compare documented specifications against the purchasing requirements; do not assume products with similar names have identical materials or performance. |
| Sterile or non-sterile supply | Whether the product is supplied sterile or non-sterile and whether that matches the intended market and use. | Product labeling, sterilization method where applicable, and relevant process-validation and lot-release documentation. | For products represented as sterile, verify the claim and supporting documentation. Applicable regulatory requirements vary by market and product. |
| Packaging and shelf life | Unit packaging, packaging integrity, storage conditions, and the stated shelf life. | Labeling, shelf-life rationale or validation summary, and packaging-validation information relevant to the product. | Check that the expiry date and storage instructions are clear and that the supplied packaging is suitable for the product’s stated status. |
| Regulatory documentation | Whether the supplier can provide documentation applicable to the intended destination market and product classification. | Applicable declarations, registrations, or other market-specific documents, as relevant to the product and jurisdiction. | ISO 13485:2016 certification alone does not establish that a product is authorized for sale in every market. |
| Traceability and post-market processes | Lot identification, complaint handling, nonconformity control, and recall communication processes. | Sample lot records, traceability procedure, and written complaint and recall procedures. | Confirm that records can link supplied goods to production lots and that the supplier explains how quality issues are escalated. |