Quality System Audit (ISO & Customer Readiness) — Interactive Checklist

{ "Title": "Quality System Audit (ISO & Customer Readiness)", "IntroductionHtml": "

Use this practical audit to verify the fundamentals of your QMS before a customer or ISO inspection. Answer the checklist items, capture evidence notes, and record any nonconformances with owners and due dates so teams can act quickly. This form is intended to be run regularly (quarterly recommended) and saved for inspection readiness and continuous improvement.

", "SubmitLabel": "Save audit entry", "SuccessMessage": "Audit saved. Nonconformances with owners and due dates will be visible to assigned teams.", "DataType": "quality-system-audit", "SchemaVersion": "1.0", "Fields": [ { "Key": "audit_date", "Label": "Audit date", "FieldType": "text", "HelpText": "YYYY-MM-DD or use local date", "Required": true }, { "Key": "auditor", "Label": "Auditor / Lead", "FieldType": "text", "Required": true }, { "Key": "site_or_department", "Label": "Site / Plant / Department", "FieldType": "text", "Required": true }, { "Key": "section_docs_exists", "Label": "Documentation & control plans — Documentation exists and is under control (versions, approvals, revision history)?", "FieldType": "yesno", "HelpText": "Check QMS manual, procedures, work instructions, control plans, and change records." }, { "Key": "section_docs_evidence", "Label": "Evidence notes (document IDs, revision numbers, location)", "FieldType": "textarea", "HelpText": "Record examples: procedure IDs, locations, or screenshots of controlled document system." }, { "Key": "section_docs_nc", "Label": "Nonconformance found in documentation?", "FieldType": "yesno" }, { "Key": "section_docs_nc_desc", "Label": "If yes, describe the nonconformance (be specific)", "FieldType": "textarea", "HelpText": "Describe missing approvals, obsolete revisions, or missing control plans." }, { "Key": "section_docs_nc_owner", "Label": "Assigned owner for documentation NC", "FieldType": "text", "HelpText": "Person or role responsible for corrective action." }, { "Key": "section_docs_nc_due", "Label": "Due date for documentation NC (YYYY-MM-DD)", "FieldType": "text" }, { "Key": "section_traceability_ok", "Label": "Traceability & genealogy — Product and batch traceability is demonstrable from raw material to finished product?", "FieldType": "yesno", "HelpText": "Inspect lot records, material ID, traveler or electronic genealogy, and serial/batch logs." }, { "Key": "section_traceability_evidence", "Label": "Traceability evidence notes (lot numbers, records found)", "FieldType": "textarea" }, { "Key": "section_traceability_nc", "Label": "Nonconformance found in traceability?", "FieldType": "yesno" }, { "Key": "section_traceability_nc_desc", "Label": "If yes, describe the gap or missing records", "FieldType": "textarea" }, { "Key": "section_traceability_nc_owner", "Label": "Assigned owner for traceability NC", "FieldType": "text" }, { "Key": "section_traceability_nc_due", "Label": "Due date for traceability NC (YYYY-MM-DD)", "FieldType": "text" }, { "Key": "section_inspection_records_ok", "Label": "Inspection & test records — Inspection results and test records are complete and retained per procedure?", "FieldType": "yesno", "HelpText": "Look for inspection checklists, gauge R&R, calibration stickers, test reports, and acceptance records." }, { "Key": "section_inspection_records_evidence", "Label": "Inspection/test records evidence (examples)", "FieldType": "textarea" }, { "Key": "section_inspection_records_nc", "Label": "Nonconformance found in inspection/test records?", "FieldType": "yesno" }, { "Key": "section_inspection_records_nc_desc", "Label": "If yes, describe missing or incomplete records", "FieldType": "textarea" }, { "Key": "section_inspection_records_nc_owner", "Label": "Assigned owner for inspection records NC", "FieldType": "text" }, { "Key": "section_inspection_records_nc_due", "Label": "Due date for inspection records NC (YYYY-MM-DD)", "FieldType": "text" }, { "Key": "section_capa_ok", "Label": "CAPA readiness — CAPAs are logged, investigated, and closed with evidence of effectiveness?", "FieldType": "yesno", "HelpText": "Inspect CAPA log, investigation notes, root cause analysis, action plans, and closure evidence." }, { "Key": "section_capa_evidence", "Label": "CAPA examples or evidence (IDs, closure notes)", "FieldType": "textarea" }, { "Key": "section_capa_nc", "Label": "Nonconformance or backlog in CAPA process?", "FieldType": "yesno" }, { "Key": "section_capa_nc_desc", "Label": "If yes, describe the issue (e.g., overdue actions, missing verification)", "FieldType": "textarea" }, { "Key": "section_capa_nc_owner", "Label": "Assigned owner for CAPA NC", "FieldType": "text" }, { "Key": "section_capa_nc_due", "Label": "Due date for CAPA NC (YYYY-MM-DD)", "FieldType": "text" }, { "Key": "section_training_ok", "Label": "Training & competency — Training records show personnel are competent and trained to current procedures?", "FieldType": "yesno", "HelpText": "Check training matrix, individual training records, and evidence of completed assessments." }, { "Key": "section_training_evidence", "Label": "Training evidence notes (course IDs, dates, records)", "FieldType": "textarea" }, { "Key": "section_training_nc", "Label": "Nonconformance found in training/comptency?", "FieldType": "yesno" }, { "Key": "section_training_nc_desc", "Label": "If yes, describe missing training, expired qualifications, or gaps", "FieldType": "textarea" }, { "Key": "section_training_nc_owner", "Label": "Assigned owner for training NC", "FieldType": "text" }, { "Key": "section_training_nc_due", "Label": "Due date for training NC (YYYY-MM-DD)", "FieldType": "text" }, { "Key": "other_observations", "Label": "Other observations or areas reviewed (environment, calibration, supplier controls)", "FieldType": "textarea" }, { "Key": "overall_risk_rating", "Label": "Overall risk/priority rating", "FieldType": "scale", "HelpText": "1 = Low priority, 5 = Immediate high priority" }, { "Key": "overall_summary", "Label": "Audit summary and recommended next steps", "FieldType": "textarea", "HelpText": "Summarize key findings, immediate containment (if any), and recommended corrective actions." }, { "Key": "follow_up_required", "Label": "Follow-up required?", "FieldType": "yesno" }, { "Key": "follow_up_owner", "Label": "Follow-up owner (if required)", "FieldType": "text" }, { "Key": "follow_up_due", "Label": "Follow-up due date (YYYY-MM-DD)", "FieldType": "text" }, { "Key": "report_distributed_to", "Label": "Report distributed to (roles/emails)", "FieldType": "text", "HelpText": "List roles or distribution list to receive this audit report." }, { "Key": "audit_sign_off", "Label": "Auditor sign-off (name)", "FieldType": "text" } ] }