ISO 13485 Filled Examples Library — Design & Development Audit (Clause 7.3) + CAPA Closure

What this bundle is

A complete, fictional, audit-ready Design & Development (ISO 13485:2016 Clause 7.3) record set for one company and one medical device, including an internal audit with exactly 3 findings and the full CAPA-based closure set that makes the file audit-closable.

The records are written to be sampled like a real audit: design planning → inputs → outputs → reviews → verification → validation → transfer → change → audit → NCRs → CAPA → effectiveness → follow-up closure.

Fiction disclaimer (non-negotiable)

This library is 100% fictional. Names, identifiers, device details, and signatures are fabricated for training and audit simulation. Do not submit these records to a regulator or use them “as-is” for a real device without competent adaptation and review.

How an auditor would sample this pack

1. Start at the DHF Index to confirm the latest versions and storage paths.
2. Use the Traceability Matrix to follow key inputs to outputs, reviews, verification/validation, transfer, and the post-V&V design change.
3. Open the Audit Report + NCRs to see the three findings with objective evidence (record IDs + storage paths).
4. Open CAPA + Effectiveness Verification to see correction vs corrective action, implementation evidence, and objective effectiveness results.
5. Confirm closure using the Follow-up Audit Plan/Checklist + Closure Report.
6. Navigate fast using the Evidence Pack Index + Evidence Index workbook.

What’s included (files you will receive)

1) DHF & Traceability control (XLSX)

• DHF_Index.xlsx (DHF_Index sheet): DHF table of contents with owners, approval dates, paths, linked records, and status.
• Registers_and_Traceability.xlsx: Inputs Register, Outputs Register, Verification Matrix, Validation Summary, Transfer Checklist, Change Impact Assessment, Traceability Matrix.

2) Design planning, inputs, and outputs (DOCX + XLSX)

• Design & Development Plan (D&D Plan)
• Design Input Requirements Specification
• Design Output Package (specs + drawings list + critical characteristics)
• Three Design Review records: Concept/Feasibility, Detailed Design, Pre-Transfer

3) Verification & Validation (DOCX + XLSX)

• Design Verification Protocol + Design Verification Report (with embedded data tables)
• Verification Matrix (traceable to inputs)
• Validation protocol/report/summary artifacts (as referenced in DHF and trace)

4) Design transfer (DOCX/XLSX)

• Transfer checklist/record set (as referenced in DHF and trace)

5) Design change post initial V&V (DOCX + XLSX)

• Design Change Request/Order package (change description, impact assessment narrative, re-verification decision, approvals)
• Change Impact Assessment worksheet (impacted records, actions, due dates, closure evidence)

6) Internal audit pack (DOCX)

• Audit Plan (scope 7.3.1–7.3.10; criteria; team; agenda; sampling plan)
• Audit Working Papers (sampling log, interview notes, trace checks, objective evidence captured)
• Audit Report with exactly 3 findings
• Three Nonconformity Reports (one per finding)

7) CAPA closure + follow-up verification (DOCX + XLSX)

• CAPA record(s): containment, root cause, correction vs corrective action, implementation evidence, effectiveness plan/results, closure approvals
• Revised DHF artifacts (controlled rev bumps) needed to close the findings
• Updated DHF Index and Traceability Matrix entries reflecting closure
• CAPA Tracker + Closure Checklist (XLSX)
• Follow-up Audit Plan/Checklist + Closure Report (scope limited to the 3 findings)

8) Auditor navigation + integrity checks (DOCX + XLSX)

• Final Evidence Pack Index (auditor-facing navigation)
• README (buyer-facing, non-marketing): file list (Record ID + file + path) and timeline
• Integrity Self-Test Output: defect list + exact edit instructions + “hostile auditor drill” script (25 challenges with evidence references)

The 3 controlled findings (and where they appear)

The baseline record set contains exactly three subtle, provable weaknesses which are later detected during the audit and then closed via CAPA. No other intentional weaknesses are introduced.

• Finding 1 → ISO 13485:2016 7.3.3 (Design Inputs): one controlled design input control weakness (appears in the baseline Design Inputs Specification / Inputs Register linkage).
• Finding 2 → ISO 13485:2016 7.3.6 (Verification): one controlled verification trace/acceptance criteria weakness (appears in the baseline Verification Protocol / Verification Matrix linkage).
• Finding 3 → ISO 13485:2016 7.3.9 (Design Change): one controlled design change control weakness (appears in the baseline design change package / impact evidence linkage).

Recommended ways to use this library

• Audit readiness training: practice sampling and defending records, then compare to the working papers and findings.
• Template accelerator: copy structure and control logic into your own formats (then replace all fictional details).
• Traceability sanity-check: use the DHF Index + Traceability Matrix patterns to validate your own end-to-end links.

Format & compatibility

• Files: DOCX and XLSX only.
• Designed for Microsoft Word/Excel and compatible suites that support DOCX/XLSX.

License / usage

Digital download for internal use. You may adapt for your organization, but do not resell or redistribute the files as templates or packs.