@pikaa-ai/pikaa 0.3.22 → 0.3.24

package/skills/infographics/SKILL.md

@@ -1,315 +0,0 @@
----
-name: infographics
-description: "Create professional infographics using Nano Banana Pro AI with smart iterative refinement. Uses Gemini 3.6 Flash for quality review. Integrates research-lookup and web search for accurate data. Supports 10 infographic types, 8 industry styles, and colorblind-safe palettes."
-allowed-tools: Read Write Edit Bash
-metadata:
-  version: "1.6"
-  openclaw:
-    primaryEnv: OPENROUTER_API_KEY
-    envVars:
-    - name: OPENROUTER_API_KEY
-      required: false
-      description: OpenRouter API key for the skill's LLM-powered steps.
----
-
-# Infographics
-
-## Overview
-
-Infographics are visual representations of information, data, or knowledge designed to present complex content quickly and clearly. **This skill uses Nano Banana Pro AI for infographic generation with Gemini 3.6 Flash quality review and Perplexity Sonar for research.**
-
-**How it works:**
-- (Optional) **Research phase**: Gather accurate facts and statistics using Perplexity Sonar
-- Describe your infographic in natural language
-- Nano Banana Pro generates publication-quality infographics automatically
-- **Gemini 3.6 Flash reviews quality** against document-type thresholds
-- **Smart iteration**: Only regenerates if quality is below threshold
-- Professional-ready output in minutes
-- No design skills required
-
-**Quality Thresholds by Document Type:**
-| Document Type | Threshold | Description |
-|---------------|-----------|-------------|
-| marketing | 8.5/10 | Marketing materials - must be compelling |
-| report | 8.0/10 | Business reports - professional quality |
-| presentation | 7.5/10 | Slides, talks - clear and engaging |
-| social | 7.0/10 | Social media content |
-| internal | 7.0/10 | Internal use |
-| draft | 6.5/10 | Working drafts |
-| default | 7.5/10 | General purpose |
-
-**Simply describe what you want, and Nano Banana Pro creates it.**
-
-## Quick Start
-
-Generate any infographic by simply describing it:
-
-```bash
-# Generate a list infographic (default threshold 7.5/10)
-python skills/infographics/scripts/generate_infographic.py \
-  "5 benefits of regular exercise" \
-  -o figures/exercise_benefits.png --type list
-
-# Generate for marketing (highest threshold: 8.5/10)
-python skills/infographics/scripts/generate_infographic.py \
-  "Product features comparison" \
-  -o figures/product_comparison.png --type comparison --doc-type marketing
-
-# Generate with corporate style
-python skills/infographics/scripts/generate_infographic.py \
-  "Company milestones 2010-2025" \
-  -o figures/timeline.png --type timeline --style corporate
-
-# Generate with colorblind-safe palette
-python skills/infographics/scripts/generate_infographic.py \
-  "Heart disease statistics worldwide" \
-  -o figures/health_stats.png --type statistical --palette wong
-
-# Generate WITH RESEARCH for accurate, up-to-date data
-python skills/infographics/scripts/generate_infographic.py \
-  "Global AI market size and growth projections" \
-  -o figures/ai_market.png --type statistical --research
-```
-
-**What happens behind the scenes:**
-1. **(Optional) Research**: Perplexity Sonar gathers accurate facts, statistics, and data
-2. **Generation 1**: Nano Banana Pro creates initial infographic following design best practices
-3. **Review 1**: **Gemini 3.6 Flash** evaluates quality against document-type threshold
-4. **Decision**: If quality >= threshold → **DONE** (no more iterations needed!)
-5. **If below threshold**: Improved prompt based on critique, regenerate
-6. **Repeat**: Until quality meets threshold OR max iterations reached
-
-**Smart Iteration Benefits:**
-- ✅ Saves API calls if first generation is good enough
-- ✅ Higher quality standards for marketing materials
-- ✅ Faster turnaround for drafts/internal use
-- ✅ Appropriate quality for each use case
-
-**Output**: Versioned images plus a detailed review log with quality scores, critiques, and early-stop information.
-
-## When to Use This Skill
-
-Use the **infographics** skill when:
-- Presenting data or statistics in a visual format
-- Creating timeline visualizations for project milestones or history
-- Explaining processes, workflows, or step-by-step guides
-- Comparing options, products, or concepts side-by-side
-- Summarizing key points in an engaging visual format
-- Creating geographic or map-based data visualizations
-- Building hierarchical or organizational charts
-- Designing social media content or marketing materials
-
-**Use scientific-schematics instead for:**
-- Technical flowcharts and circuit diagrams
-- Biological pathways and molecular diagrams
-- Neural network architecture diagrams
-- CONSORT/PRISMA methodology diagrams
-
----
-
-## Research Integration
-
-### Automatic Data Gathering (`--research`)
-
-When creating infographics that require accurate, up-to-date data, use the `--research` flag to automatically gather facts and statistics using **Perplexity Sonar Pro**.
-
-```bash
-# Research and generate statistical infographic
-python skills/infographics/scripts/generate_infographic.py \
-  "Global renewable energy adoption rates by country" \
-  -o figures/renewable_energy.png --type statistical --research
-
-# Research for timeline infographic
-python skills/infographics/scripts/generate_infographic.py \
-  "History of artificial intelligence breakthroughs" \
-  -o figures/ai_history.png --type timeline --research
-
-# Research for comparison infographic
-python skills/infographics/scripts/generate_infographic.py \
-  "Electric vehicles vs hydrogen vehicles comparison" \
-  -o figures/ev_hydrogen.png --type comparison --research
-```
-
-### What Research Provides
-
-The research phase automatically:
-
-1. **Gathers Key Facts**: 5-8 relevant facts and statistics about the topic
-2. **Provides Context**: Background information for accurate representation
-3. **Finds Data Points**: Specific numbers, percentages, and dates
-4. **Cites Sources**: Mentions major studies or sources
-5. **Prioritizes Recency**: Focuses on 2023-2026 information
-
-### When to Use Research
-
-**Enable research (`--research`) for:**
-- Statistical infographics requiring accurate numbers
-- Market data, industry statistics, or trends
-- Scientific or medical information
-- Current events or recent developments
-- Any topic where accuracy is critical
-
-**Skip research for:**
-- Simple conceptual infographics
-- Internal process documentation
-- Topics where you provide all the data in the prompt
-- Speed-critical generation
-
-### Research Output
-
-When research is enabled, additional files are created:
-- `{name}_research.json` - Raw research data and sources
-- Research content is automatically incorporated into the infographic prompt
-
----
-
-## Infographic Types
-
-Ten types are supported via `--type`: `statistical`, `timeline`, `process`, `comparison`,
-`list`, `geographic`, `hierarchical`, `anatomical`, `resume`, and `social`. What each is
-for, the data shape it expects, and worked prompts are in
-[references/infographic_type_catalog.md](references/infographic_type_catalog.md) and
-[references/infographic_types.md](references/infographic_types.md).
-
-## Style Presets
-
-### Industry Styles (`--style`)
-
-| Style | Colors | Best For |
-|-------|--------|----------|
-| `corporate` | Navy, steel blue, gold | Business reports, finance |
-| `healthcare` | Medical blue, cyan, light cyan | Medical, wellness |
-| `technology` | Tech blue, slate, violet | Software, data, AI |
-| `nature` | Forest green, mint, earth brown | Environmental, organic |
-| `education` | Academic blue, light blue, coral | Learning, academic |
-| `marketing` | Coral, teal, yellow | Social media, campaigns |
-| `finance` | Navy, gold, green/red | Investment, banking |
-| `nonprofit` | Warm orange, sage, sand | Social causes, charities |
-
-```bash
-# Corporate style
-python skills/infographics/scripts/generate_infographic.py \
-  "Q4 Results" -o q4.png --type statistical --style corporate
-
-# Healthcare style
-python skills/infographics/scripts/generate_infographic.py \
-  "Patient Journey" -o journey.png --type process --style healthcare
-```
-
----
-
-## Colorblind-Safe Palettes
-
-### Available Palettes (`--palette`)
-
-| Palette | Colors | Description |
-|---------|--------|-------------|
-| `wong` | Orange, sky blue, green, blue, vermillion | Most widely recommended |
-| `ibm` | Ultramarine, indigo, magenta, orange, gold | IBM's accessible palette |
-| `tol` | 12-color extended palette | For many categories |
-
-```bash
-# Wong's colorblind-safe palette
-python skills/infographics/scripts/generate_infographic.py \
-  "Survey results by category" -o survey.png --type statistical --palette wong
-```
-
----
-
-## Smart Iterative Refinement and CLI
-
-The generate-review-refine loop, every command-line option, and configuration are in
-[references/iterative_refinement.md](references/iterative_refinement.md).
-
-## Prompt Engineering Tips
-
-### Be Specific About Content
-
-✓ **Good prompts** (specific, detailed):
-```
-"5 benefits of meditation: reduces stress, improves focus, 
-better sleep, lower blood pressure, emotional balance"
-```
-
-✗ **Avoid vague prompts**:
-```
-"meditation infographic"
-```
-
-### Include Data Points
-
-✓ **Good**:
-```
-"Market growth from $10B (2020) to $45B (2025), CAGR 35%"
-```
-
-✗ **Vague**:
-```
-"market is growing"
-```
-
-### Specify Visual Elements
-
-✓ **Good**:
-```
-"Timeline showing 5 milestones with icons for each event"
-```
-
----
-
-## Reference Files
-
-For detailed guidance, load these reference files:
-
-- **`references/infographic_types.md`**: Extended templates for all 10+ types
-- **`references/design_principles.md`**: Visual hierarchy, layout, typography
-- **`references/color_palettes.md`**: Full palette specifications
-
----
-
-## Troubleshooting
-
-### Common Issues
-
-**Problem**: Text in infographic is unreadable
-- **Solution**: Reduce text content; use --type to specify layout type
-
-**Problem**: Colors clash or are inaccessible
-- **Solution**: Use `--palette wong` for colorblind-safe colors
-
-**Problem**: Quality score too low
-- **Solution**: Increase iterations with `--iterations 3`; use more specific prompt
-
-**Problem**: Wrong infographic type generated
-- **Solution**: Always specify `--type` flag for consistent results
-
----
-
-## Integration with Other Skills
-
-This skill works synergistically with:
-
-- **scientific-schematics**: For technical diagrams and flowcharts
-- **market-research-reports**: Infographics for business reports
-- **scientific-slides**: Infographic elements for presentations
-- **generate-image**: For non-infographic visual content
-
----
-
-## Quick Reference Checklist
-
-Before generating:
-- [ ] Clear, specific content description
-- [ ] Infographic type selected (`--type`)
-- [ ] Style appropriate for audience (`--style`)
-- [ ] Output path specified (`-o`)
-- [ ] API key configured
-
-After generating:
-- [ ] Review the generated image
-- [ ] Check the review log for scores
-- [ ] Regenerate with more specific prompt if needed
-
----
-
-Use this skill to create professional, accessible, and visually compelling infographics using the power of Nano Banana Pro AI with intelligent quality review.

package/skills/iso-standards-readiness/SKILL.md

@@ -1,352 +0,0 @@
----
-name: iso-standards-readiness
-description: Prepares and structurally reviews readiness evidence for ISO management-system and laboratory-competence standards - ISO 13485 medical device QMS, ISO 14971 device risk management, ISO/IEC 17025 testing and calibration laboratories, and ISO 15189 medical laboratories. Use when organizing declared scope, controlled documents, risk-management files, scope of accreditation, traceability, CAPA, external-provider controls, or bounded local evidence manifests, and when separating ISO certification from laboratory accreditation, FDA QMSR inspection, CLIA certification, MDSAP, and EU MDR/IVDR evidence boundaries. Not for legal applicability, compliance, certification, or accreditation decisions; contains no clause text.
-license: MIT
-compatibility: Python 3.11+; bundled CLIs use only the standard library and bounded local JSON/Markdown files, with no network access or credentials.
-allowed-tools: Read Write Bash Glob
-metadata:
-  version: "1.0"
-  skill-author: K-Dense Inc.
-  supersedes: iso-13485-certification
-  last-reviewed: "2026-07-26"
----
-
-# ISO Standards Readiness Evidence Preparation
-
-## Purpose
-
-Use this skill to organize declared scope, controlled documents, implementation
-records, traceability, and readiness evidence for substantive human review against a
-named standard. It summarizes process workflows and provides deterministic local
-checks. It contains no clause text and performs no audit.
-
-This is a router. `SKILL.md` holds the boundary, the lane discipline, the shared
-workflow, and the CLI contract. Per-standard depth lives in `references/`.
-
-## Non-negotiable boundary
-
-This skill cannot:
-
-- certify or accredit anything, issue or validate a certificate, accreditation
-  schedule, or licence, or promise an audit, assessment, or inspection result;
-- determine legal/regulatory applicability, device classification, reportability,
-  conformity route, product authorization, market access, licensure, personnel
-  qualification, or compliance;
-- replace authorized management, the management representative, laboratory director,
-  quality manager, authorized signatory, RA/QA, legal counsel, regulatory/competent
-  authorities, a notified body, an MDSAP Auditing Organization, an accreditation body,
-  an assessor, or a certification body;
-- validate a method, compute or approve measurement uncertainty, establish
-  metrological traceability, set risk-acceptability criteria, or judge whether a risk,
-  decision rule, or reference interval is fit for purpose; or
-- infer implementation, competence, conformity, compliance, or readiness from a
-  template, checklist, filename, keyword, document count, percentage, or script
-  result.
-
-Always label outputs **draft evidence-preparation material for authorized human
-review**. Preserve unresolved decisions as blockers rather than resolving them.
-
-## ISO and IEC copyright
-
-ISO and IEC standards are copyrighted. Obtain each standard from
-[ISO](https://www.iso.org/standards.html), IEC, an ISO national member, or another
-authorized source. Do not retrieve, paste, reproduce, or generate clause text.
-Summarize the organization's own process and cite the controlled authorized copy. See
-[ISO copyright](https://www.iso.org/copyright.html). Accreditation-body, CAP, and
-scheme checklists that quote requirements are separately licensed — keep them out of
-shared repositories and prompts too.
-
-## Standards covered
-
-Read the reference file for the standard in play **before** preparing evidence. Each
-one carries its own current edition, lane, domain vocabulary, and failure modes.
-
-| Standard | Profile key | Lane | Reference |
-| --- | --- | --- | --- |
-| ISO 13485 medical device QMS | `iso-13485` | Certification | `references/iso-13485.md` |
-| ISO 14971 device risk management | `iso-14971` | No lane of its own | `references/iso-14971.md` |
-| ISO/IEC 17025 testing and calibration laboratories | `iso-17025` | Accreditation | `references/iso-17025.md` |
-| ISO 15189 medical laboratories | `iso-15189` | Accreditation | `references/iso-15189.md` |
-
-A standard absent from this table is out of scope for the bundled checks. Do not
-repurpose a profile for a standard it does not name — a domain vocabulary borrowed from
-a different standard produces a report that looks complete and means nothing.
-
-## Current baseline (read the ledger before any time-sensitive statement)
-
-- **ISO 13485:2016** Edition 3, confirmed after its 2025 systematic review.
-  **EN ISO 13485:2016/A11:2021** is a European amendment, not an ISO international
-  "Amendment 1:2021."
-- **ISO 14971:2019** Edition 3, confirmed in 2025, with **ISO/TR 24971:2020** as its
-  informative guidance companion. There is no ISO 14971 certificate.
-- **ISO/IEC 17025:2017** Edition 3 remains current; no successor edition identified.
-- **ISO 15189:2022** Edition 4 replaced the 2012 edition, absorbed the POCT
-  requirements formerly in ISO 22870, and its accreditation transition closed in
-  **December 2025** — implemented, not upcoming.
-- **FDA QMSR** effective and enforced since **2026-02-02**; Part 820 is titled
-  *Quality Management System Regulation*; QSIT is retired in favour of Compliance
-  Program **7382.850**.
-- **MDSAP** current Audit Approach is **MDSAP AU P0002.010**, version date
-  **2026-02-02**.
-- **Accreditation recognition:** Global Accreditation Cooperation Incorporated
-  commenced full operations **2026-01-01**, replacing ILAC and IAF, with its own MRA;
-  former IAF MLA / ILAC MRA outputs stay recognized during the transition.
-- **EU:** use current consolidated MDR/IVDR texts, current OJEU harmonised-standard
-  decisions, current MDCG guidance, and the product-specific conformity route.
-
-Read `references/source-ledger.md` before making any time-sensitive statement. It
-records provenance limitations, including which entries still need confirmation against
-the ISO catalogue.
-
-## Keep the assurance lanes separate
-
-Lane confusion, not missing documents, causes most substantive errors here.
-Certification, accreditation, regulator inspection, mandatory licensure, regulatory
-audit programmes, and product conformity assessment are decided by different bodies
-against different bases, and none substitutes for another. Two rules that are violated
-constantly:
-
-- Organizations are **certified**; laboratories are **accredited**. "ISO 17025
-  certified" and "ISO 15189 certified" are category errors.
-- A certificate never displaces a regulator. ISO 13485 certification does not exempt
-  anyone from FDA inspection, and ISO 15189 accreditation does not satisfy CLIA.
-
-Read `references/assurance-lanes.md` for the full lane table, scope-statement limits,
-and the titling rule.
-
-## Core workflow
-
-### Step 1: Declare the standard, purpose, and authorized owners
-
-Name the standard(s), the lane(s) the work supports, and the owners: management
-representative or laboratory director, quality owner, legal/applicability owner,
-process or technical owners, approvers, and escalation route. A lane is a declared
-input, never an inference.
-
-```bash
-PYTHONDONTWRITEBYTECODE=1 python3 scripts/validate_scope_intake.py \
-  assets/templates/scope-intake-template.json --standard iso-13485
-```
-
-Use the matching template and profile:
-
-| Profile | Template |
-| --- | --- |
-| `iso-13485`, `iso-14971` | `assets/templates/scope-intake-template.json` |
-| `iso-17025` | `assets/templates/laboratory-scope-intake-template.json` |
-| `iso-15189` | `assets/templates/medical-laboratory-scope-intake-template.json` |
-
-`--standard` defaults to `iso-13485`. Every distributed template intentionally fails
-closed; copy it outside the skill and complete it with controlled organizational
-evidence. Undetermined applicability raises `HUMAN_DECISION_REQUIRED` — leave it as a
-blocker.
-
-### Step 2: Freeze source/version evidence
-
-For every standard, regulation, guidance, scheme document, audit model, and product
-source, record publisher, official title, edition/version/date, authorized location,
-access and currency-review dates, scope/applicability owner, impact assessment, status,
-evidence, and approval.
-
-Do not use search snippets as controlled requirements. Do not silently update an
-incorporated edition when a publisher releases a new one — FDA incorporated a specific
-ISO 13485 edition, and a later ISO or EN publication does not change it.
-
-### Step 3: Inventory controlled documents and records
-
-Do not count named procedures or scan keywords. Build an explicit register linking
-documents, records, source versions, owners, approvals, effective dates, retention
-bases, training, and change records.
-
-```bash
-PYTHONDONTWRITEBYTECODE=1 python3 scripts/audit_document_records.py \
-  assets/templates/document-register-template.json
-```
-
-This check is standard-agnostic. Read `references/evidence-architecture.md` for the
-evidence architecture.
-
-### Step 4: Review process implementation
-
-Assess controlled procedures **and sampled records** across the domains your profile
-declares — the per-standard reference file lists them. Each item needs owner, status,
-evidence IDs, source/version, approval, and open-gap links.
-
-A procedure describing an activity is not evidence the activity happened. Sample
-records in every domain you report on, and state what you sampled and what you did not.
-
-### Step 5: Run the focused checks that apply to the lane
-
-Device lanes (`iso-13485`, `iso-14971`) — risk/design/production/post-market chain:
-
-```bash
-PYTHONDONTWRITEBYTECODE=1 python3 scripts/check_traceability.py \
-  assets/templates/traceability-matrix-template.json
-```
-
-All standards — corrective action and effectiveness:
-
-```bash
-PYTHONDONTWRITEBYTECODE=1 python3 scripts/check_capa.py \
-  assets/templates/capa-record-template.json
-```
-
-All standards — suppliers and externally provided products and services, including
-calibration providers, reference-material suppliers, and referral or subcontracted
-laboratories:
-
-```bash
-PYTHONDONTWRITEBYTECODE=1 python3 scripts/check_supplier_controls.py \
-  assets/templates/supplier-controls-template.json
-```
-
-Pending or ineffective CAPA effectiveness evidence blocks closure. Critical supplier
-controls stay blocked until risk-based controls and approvals are evidenced.
-
-Note that `check_traceability.py` concerns design and risk traceability, **not**
-metrological traceability — the words collide and it is the wrong tool for laboratory
-work.
-
-### Step 6: Address lane-specific regulator evidence separately
-
-For the US device lane only:
-
-```bash
-PYTHONDONTWRITEBYTECODE=1 python3 scripts/check_qmsr_transition.py \
-  assets/templates/qmsr-transition-template.json
-```
-
-Review current Part 820/FDA source basis, supplemental provisions, obsolete QSR/QSIT
-references, pre-effective-date records, inspection-accessible management/quality/
-supplier-audit records, current inspection-process training, complaint and servicing
-records, labeling/packaging controls, supplier/software/change evidence, and prohibited
-certificate-equivalence claims. Do not build an old-820-to-ISO clause map as the
-current control framework.
-
-Laboratory lanes have no equivalent bundled check. CLIA, licensure, and national
-inspection evidence stays with the authorized compliance owner; see
-`references/iso-15189.md`.
-
-### Step 7: Assemble a bounded readiness manifest
-
-Copy the evidence template outside the skill. Use relative paths to local `.json`,
-`.md`, or `.markdown` evidence only, and one declared lane purpose per manifest.
-
-```bash
-PYTHONDONTWRITEBYTECODE=1 python3 scripts/validate_evidence_manifest.py \
-  /path/to/evidence-manifest.json \
-  --standard iso-17025 \
-  --base-dir /path/to/controlled-export \
-  --verify-files \
-  --output /path/to/manifest-report.json
-```
-
-Then generate a domain-level gap view against the same profile:
-
-```bash
-PYTHONDONTWRITEBYTECODE=1 python3 scripts/gap_analyzer.py \
-  /path/to/evidence-manifest.json \
-  --standard iso-17025 \
-  --base-dir /path/to/controlled-export \
-  --verify-files \
-  --output /path/to/gap-report.json
-```
-
-The analyzer uses explicit manifest labels. It does not infer evidence from filenames,
-keywords, or proprietary standard text, and does not calculate a compliance score. A
-domain absent from `expected_domains` is reported `not-assessed`, which is **not** a
-not-applicable determination.
-
-Read `references/gap-analysis-checklist.md` for the fail-closed review questions.
-
-### Step 8: Human review and controlled handoff
-
-Present:
-
-- declared standard, scope, assurance lane(s), and unresolved applicability decisions;
-- the exact source/version baseline;
-- evidence sampled and the limitations of that sample;
-- structural findings grouped by process and risk;
-- actions, change, and CAPA owners with dates;
-- approval state; and
-- the authorized party responsible for the next decision.
-
-Never title the result "certificate," "accreditation," "compliance report," "audit
-pass," "deemed status," or "ready for inspection." A suitable title is **Draft evidence
-review for authorized human assessment**, naming the lane it was prepared for.
-
-## CLI behavior and safety
-
-All bundled CLIs:
-
-- use the Python standard library only;
-- perform no network requests;
-- accept bounded local JSON; optional evidence verification accepts only bounded local
-  JSON/Markdown;
-- reject symbolic-link inputs, duplicate JSON keys, non-finite numbers, excessive
-  size/nesting/items, and unsafe evidence paths;
-- refuse an unlisted `--standard` value rather than falling back to a default;
-- use no dynamic evaluation, executable deserialization, pickle, or shell execution;
-- refuse to overwrite reports unless `--force` is explicit; and
-- produce deterministic sorted JSON.
-
-Treat the manifest itself as a controlled organizational record. An optional SHA-256
-comparison detects a local file mismatch only; it does not establish provenance,
-authenticity, adequacy, or trust in a user-supplied manifest. Values in JSON
-`local_path` and `evidence.location` fields refer to the user's controlled export, not
-to bundled skill resources; unresolved placeholders must never be opened.
-
-Exit codes:
-
-- `0`: no structural finding for the supplied fields; **not a compliance, conformity,
-  competence, or accreditation result**;
-- `1`: structural/evidence gaps found;
-- `2`: invalid or unsafe input/output, including an unlisted standard.
-
-Run `python3 scripts/<name>.py --help` for each interface.
-
-## Templates
-
-Scope intake, per profile:
-
-- `assets/templates/scope-intake-template.json` — device lifecycle
-- `assets/templates/laboratory-scope-intake-template.json` — testing/calibration
-- `assets/templates/medical-laboratory-scope-intake-template.json` — examinations
-
-Shared registers and records:
-
-- `assets/templates/document-register-template.json`
-- `assets/templates/capa-record-template.json`
-- `assets/templates/traceability-matrix-template.json`
-- `assets/templates/supplier-controls-template.json`
-- `assets/templates/evidence-manifest-template.json`
-- `assets/templates/qmsr-transition-template.json` — US device lane only
-
-Management-system documentation:
-
-- `assets/templates/quality-manual-template.md`
-- `assets/templates/procedures/CAPA-procedure-template.md`
-- `assets/templates/procedures/document-control-procedure-template.md`
-
-Every template is deliberately `draft`/`pending`, uses placeholders, and includes
-owner/status/evidence/approval fields. Copy and control it; never edit a distributed
-template into a purported approved record.
-
-## References
-
-Shared:
-
-- `references/assurance-lanes.md` — what each lane decides, and the titling rule
-- `references/source-ledger.md` — dated authoritative source baseline and provenance
-  limitations
-- `references/evidence-architecture.md` — documentation and record architecture
-- `references/gap-analysis-checklist.md` — fail-closed evidence review questions
-- `references/quality-manual-guide.md` — controlled manual development
-
-Per standard:
-
-- `references/iso-13485.md` — device QMS process/evidence framework, QMSR, MDSAP, EU
-- `references/iso-14971.md` — risk-management chain and the missing-link failure modes
-- `references/iso-17025.md` — laboratory competence, traceability, uncertainty, and
-  decision rules
-- `references/iso-15189.md` — medical laboratories, POCT, reporting, and the CLIA lane