Design History File — Master Index

Document Control

Document ID	DHF-001
Version	1.0
Date	2026-03-22
Author	pacs008 Engineering
Status	Released
Classification	Internal

Purpose

This Design History File (DHF) provides ISO 13485:2016-equivalent documentation rigor for the pacs008 library — a Python library for generating ISO 20022 pacs.008 FI-to-FI Customer Credit Transfer XML messages.

While pacs008 is financial infrastructure software rather than a medical device, this DHF applies the same systematic design control discipline required by ISO 13485:2016 clause 7.3 to demonstrate that the software was developed under a controlled, traceable, and verified process. This approach satisfies institutional audit requirements and establishes readiness for regulated deployment environments.

Scope

• Product: pacs008 Python library

• Version: 0.0.1

• Message standard: ISO 20022 pacs.008.001.01 through pacs.008.001.13 (all 13 versions)

• IEC 62304 safety classification: Class A (voluntary Class C processes applied)

Document Set

#	ID	Document	ISO 13485 Clause
1	DHF-001	Design History File — Master Index (this document)	7.3.10 (DHF overview)
2	DHF-002	Design and Development Plan	7.3.1, 7.3.2
3	DHF-003	Software Requirements Specification	7.3.3
4	DHF-004	Software Architecture Document	7.3.4
5	DHF-005	Risk Management File	7.3.4, ISO 14971, IEC 62304
6	DHF-006	Verification and Validation Plan	7.3.5, 7.3.6, 7.3.7
7	DHF-007	Traceability Matrix	7.3.10
8	DHF-008	Design Review and Change Control	7.3.4, 7.3.9
9	DHF-009	Configuration Management and Design Transfer	7.3.8, 4.2.3

DHF Documents

• Design and Development Plan
  • 1. Scope
  • 2. Applicable Standards
  • 3. Development Methodology
  • 4. Development Phases
  • 5. Tools and Environment
  • 6. Quality Gates
  • 7. Deliverables
• Software Requirements Specification
  • 1. Functional Requirements
  • 2. Non-Functional Requirements
• Software Architecture Document
  • 1. Module Architecture
  • 2. Data Flow
  • 3. Version Dispatch Strategy
  • 4. Exception Hierarchy
  • 5. Security Architecture
  • 6. Interface Specifications
  • 7. Design Decisions and Rationale
• Risk Management File
  • 1. IEC 62304 Safety Classification
  • 2. Risk Analysis Methodology
  • 3. Risk Register
  • 4. Risk Control Verification
  • 5. Residual Risk Assessment
• Verification and Validation Plan
  • 1. Test Strategy
  • 2. Test Categories and Markers
  • 3. Test File Inventory
  • 4. Gold Master Tests
  • 5. Static Analysis Tools
  • 6. CI Pipeline
  • 7. Acceptance Criteria
• Traceability Matrix
  • 1. Forward Traceability: Requirement to Implementation to Test
  • 2. Reverse Traceability: Test File to Requirements
  • 3. Risk Control Traceability
• Design Review and Change Control
  • 1. Design Review Records
  • 2. Change Control Log
  • 3. Design Change Process
• Configuration Management and Design Transfer
  • 1. Version Control
  • 2. Commit Policy
  • 3. Pre-commit Hooks
  • 4. Configuration Items
  • 5. Baseline Definition
  • 6. Release Process Checklist
  • 7. Deployment Architecture

Standards Compliance Cross-Reference

Standard	Clause	DHF Coverage
ISO 13485:2016	7.3.1	DHF-002 Design and Development Planning
ISO 13485:2016	7.3.2	DHF-002 Design and Development Inputs
ISO 13485:2016	7.3.3	DHF-003 Software Requirements Specification
ISO 13485:2016	7.3.4	DHF-004 Software Architecture, DHF-005 Risk Management
ISO 13485:2016	7.3.5	DHF-006 Verification and Validation Plan
ISO 13485:2016	7.3.6	DHF-006 Design Validation
ISO 13485:2016	7.3.7	DHF-008 Design Review and Change Control
ISO 13485:2016	7.3.8	DHF-009 Configuration Management and Design Transfer
ISO 13485:2016	7.3.9	DHF-008 Design Changes
ISO 13485:2016	7.3.10	DHF-001 (this document), DHF-007 Traceability Matrix
ISO 13485:2016	4.2.3	DHF-009 Document Control
ISO 14971:2019	All	DHF-005 Risk Management File
IEC 62304:2006+A1	All	DHF-002 through DHF-009

Approval Signatures

Role	Name	Signature	Date
Lead Engineer
Quality Assurance
Regulatory Affairs