ISO_13485 | Medical Device QMS Compliance

Overview

ISO_13485 is a deterministic compliance domain for medical device quality management systems based on ISO 13485:2003(E).

It is clause-anchored, reproducible, and designed for audit readiness, CAPA workflows, implementation planning, and governance reporting.

Variation Coverage

Variation 1

Basic Retrieval

7 tools

Variation 2

Audit & CAPA

6 tools

Variation 3

Implementation Playbooks

5 tools

Variation 4

Governance

5 tools

Canonical Dataset

Artifact	Location	Purpose
Source	`data/ISO13485_gemini.md`	Canonical text source for domain generation
Chunk Index	`data/iso13485_source_gemini/chunks.jsonl`	220-word windows with 40-word overlap
Page Records	`data/iso13485_source_gemini/ocr_pages.jsonl`	Structured section and page retrieval
FTS Store	`data/iso13485_source_gemini/fts_store.sqlite`	Offline full-text retrieval (no API required)

Representative Tools

GetClauseText

Fetch exact ISO clause text by number (for example 7.3 or 8.5).

BuildAuditChecklist

Generate clause-focused internal audit checklists and evidence prompts.

BuildRolePlaybook

Create role-based implementation playbooks for QA, RA, Ops, and Design teams.

GenerateComplianceMatrix

Build cross-clause obligation matrices from "shall" statements.

CLI Quick Start

# From project-phoenix/domains/ISO_13485 python3 test_agent.py # Rebuild canonical artifacts python3 scripts/build_gemini_domain_dataset.py --source data/ISO13485_gemini.md --out-dir data/iso13485_source_gemini python3 scripts/build_fts_index.py --input data/iso13485_source_gemini/chunks.jsonl --db-path data/iso13485_source_gemini/fts_store.sqlite --replace # Query local full-text index python3 scripts/query_fts.py "risk management" -k 5