| 1 | Quality Management System | ISO 9001:2015 or an equivalent documented quality system | Valid certificate, certification scope, issuing body, certificate number, and expiry date | Certificate scope covers the supplied product and manufacturing site; certificate is independently verifiable | Before approval and annually |
| 2 | Product Safety and Conformity | Applicable IEC, EN, or national safety requirements for the product category | Test reports from an accredited laboratory, technical file, risk assessment, and declaration of conformity where applicable | Test report model, revision, and rated specifications match the purchased product | At product launch and after design changes |
| 3 | Restricted Substances | RoHS Directive 2011/65/EU and amendment (EU) 2015/863; REACH Regulation (EC) No 1907/2006 where applicable | Material declarations, component supplier declarations, and laboratory screening results for high-risk materials | Documentation covers all assemblies, cables, coatings, and packaging; restricted substance limits are met | At onboarding and whenever materials change |
| 4 | Incoming and Final Inspection | ISO 2859-1 sampling principles and an approved inspection specification | Control plan, inspection records, calibrated equipment list, defect classification, and approved golden sample | Critical defects: zero; major and minor defect limits defined by purchase agreement and product risk | Every production lot |
| 5 | Traceability and Change Control | Documented lot traceability and formal engineering change notification process | Lot codes, bill of materials, production dates, component records, retention policy, and change-notice template | Finished goods can be traced to production lot, key components, inspection results, and shipment records | Each shipment and every approved change |
| 6 | Supplier Delivery Reliability | Purchase-order performance measured using confirmed dates and quantities | At least 6–12 months of on-time-in-full records, capacity plan, lead-time data, and escalation contacts | Target on-time-in-full delivery rate of at least 95%; late-order root causes documented and corrected | Monthly performance review |
| 7 | Corrective Action and Business Continuity | CAPA process, risk-based supplier management, and documented continuity planning | Recent corrective-action reports, failure analysis, backup component sources, disaster-recovery plan, and insurance information | Containment within 24 hours for critical issues; corrective-action plan within 10 business days; recovery alternatives identified | After every major issue and annually |
| 8 | Independent Audit and Sample Approval | Pre-production approval, first-article inspection, and risk-based independent audit | Audit report, sample test results, approved drawings, signed specifications, and action-item closure records | No unresolved critical findings; production begins only after sample and specification approval | Before first order and when risk changes |