This repository provides a modular, system-oriented toolkit for standing up or evaluating compliance-aligned quality operations in regulated or production manufacturing environments. It is designed for engineering, MSAT, and QA-adjacent teams building, refactoring, or assessing Quality Management Systems (QMS) across:
- Biotech or pharmaceutical manufacturing (GMP, cGMP, 21 CFR 210/211)
- Medical device development (ISO 13485, 21 CFR 820)
- Semiconductor or hardware production (ISO 9001, IATF-like systems)
- Tech teams preparing for ISO/FDA hybrid readiness (e.g., IEC 62304, ICH Q10)
This kit supports organizations that need to:
- Bootstrap or re-structure a scalable, audit-aligned QMS
- Conduct gap analysis against ISO or GMP standards
- Align engineering documentation with QA expectations
- Plan for ownership mapping, audit traceability, or training setup
- Cross-walk between ISO 9001 and FDA-regulated environments
| Folder | Description |
|---|---|
/templates/ |
SOP templates, audit logs, and documentation stubs for QMS execution |
/trackers/ |
Editable spreadsheets for training, change control, rollout, and ownership tracking |
/reference/ |
Clause breakdowns, cross-framework matrices, and glossary terms |
/diagrams/ |
(Optional) Visual aids for QMS structure or mapping workflows |
| Asset Filename | Folder | Linked Theme(s) |
|---|---|---|
| audit_log_v1_20250621.xlsx | /templates/ |
Deviation Management, CAPA, QA Review |
| sop_template_v1_20250621.docx | /templates/ |
Document Control, Change Management |
| training_matrix_v1_20250623.xlsx | /trackers/ |
Training & Qualification |
| change_tracker_v1_20250623.xlsx | /trackers/ |
Change Management, CAPA |
| project_tracker_gantt_v1_20250623.xlsx | /trackers/ |
Operational Planning, Cross-functional Coordination |
| asset_ownership_table_v1_20250623.xlsx | /trackers/ |
Management Responsibility, Function Accountability |
| compliance_clause_breakdown_table_v1_20250621.xlsx | /reference/ |
All QMS Themes (Filterable clause list) |
| cross-framework_mapping_matrix_v1_20250621.xlsx | /reference/ |
All QMS Themes (Framework comparison table) |
Clone or fork this repo into an internal system setup environment. From there, teams can:
- Tailor SOP templates to reflect product-specific or process-specific procedures
- Populate trackers with site-level ownership, audit schedules, or training goals
- Extend theme categories to match internal compliance pillars
- Map documentation systems to external standards for audit prep
This kit is most useful when paired with team-level review and QA oversight.
- This toolkit is not a legal or regulatory authority
- Final validation must be performed by your internal Quality, RA, or Compliance teams
- Clause mappings and interpretations are based on publicly available summaries; teams must confirm accuracy for their jurisdiction and process scope
This starter kit is for:
- Engineering, MSAT, or ops teams supporting QMS setup or audit readiness
- QA-adjacent groups aligning legacy systems with updated frameworks
- Cross-functional leads managing tech transfer or GMP/ISO scale-up
This kit is not intended as:
- A certification-ready clause database
- Legal interpretation of ISO or FDA guidelines
- A turnkey system install without QA involvement
Provided as-is under the MIT License. Organizations are encouraged to adapt and extend this toolkit for internal use.