{"slug":"alterlab-iso13485","title":"alterlab-iso13485","summary":"Prepares ISO 13485 certification documentation for medical device Quality Management Systems (QMS) — gap analysis of existing documentation, Quality Manuals, required procedures and work instructions, and Medical Device Files. Use for ISO 13485 QMS documentation, conducting a doc","platform":"Claude","tags":[],"authorName":"LLM Mart","authorSlug":"llm-mart","score":0,"source":"github","price":null,"verified":false,"createdAt":"2026-09-23T18:57:00.617233Z","repo":{"url":"https://github.com/AlterLab-IEU/AlterLab-Academic-Skills","stars":68,"forks":13,"license":"MIT","updatedAt":"2026-09-23T13:42:59Z"},"bodyHtml":"<hr>\n<h2>name: alterlab-iso13485\ndescription: Prepares ISO 13485 certification documentation for medical device Quality Management Systems (QMS) — gap analysis of existing documentation, Quality Manuals, required procedures and work instructions, and Medical Device Files. Use for ISO 13485 QMS documentation, conducting a documentation gap analysis, drafting a Quality Manual or SOP/work instruction, assembling a Medical Device File, identifying missing documentation for medical device certification, or when medical device regulations, QMS certification, FDA QMSR, or EU MDR are mentioned. Part of the AlterLab Academic Skills suite.\nlicense: MIT\nallowed-tools: Read Write Edit Bash(python:<em>)\ncompatibility: \"Self-contained — runs with Read/Write/Edit/Bash(python:</em>); no API key or account required.\"\nmetadata:\nskill-author: AlterLab\nversion: \"1.1.0\"\nlast_updated: \"2026-09-23\"</h2>\n<h1>ISO 13485 Certification Documentation Assistant</h1>\n<h2>Overview</h2>\n<p>This skill helps medical device manufacturers prepare comprehensive documentation for ISO 13485:2016 certification. It provides tools, templates, references, and guidance to create, review, and gap-analyze all required Quality Management System (QMS) documentation.</p>\n<p><strong>What this skill provides:</strong></p>\n<ul>\n<li>Gap analysis of existing documentation</li>\n<li>Templates for all mandatory documents</li>\n<li>Comprehensive requirements guidance</li>\n<li>Step-by-step documentation creation</li>\n<li>Identification of missing documentation</li>\n<li>Compliance checklists</li>\n</ul>\n<p>The output is documentation support. Certification decisions come from an accredited certification body, and regulatory strategy (FDA, EU notified bodies) needs review by qualified QA/RA staff, so present drafts and gap findings as inputs to that review rather than as compliance determinations.</p>\n<h2>When to Use This Skill</h2>\n<ul>\n<li>Starting the ISO 13485 certification process</li>\n<li>Conducting gap analysis against ISO 13485</li>\n<li>Creating or updating QMS documentation (Quality Manual, SOPs, work instructions, Medical Device Files)</li>\n<li>Preparing for a certification or surveillance audit</li>\n<li>Updating a QSR-based QMS for the FDA QMSR (in effect since 2 February 2026)</li>\n<li>Aligning QMS documentation with EU MDR/IVDR requirements</li>\n</ul>\n<h3>Does NOT Trigger</h3>\n<table>\n<thead>\n<tr>\n<th>Scenario</th>\n<th>Use Instead</th>\n</tr>\n</thead>\n<tbody>\n<tr>\n<td>Looking up 510(k)/PMA clearances, device recalls, or MAUDE adverse-event reports</td>\n<td><code>alterlab-fda</code></td>\n</tr>\n<tr>\n<td>Writing a clinical study report, SAE narrative, or case report</td>\n<td><code>alterlab-clinical-reports</code></td>\n</tr>\n<tr>\n<td>IRB/ethics applications and informed-consent documents for a device study</td>\n<td><code>alterlab-research-ethics</code></td>\n</tr>\n<tr>\n<td>An individual patient's care or treatment plan</td>\n<td><code>alterlab-treatment-plans</code></td>\n</tr>\n</tbody>\n</table>\n<h2>Regulatory Status (checked September 2026)</h2>\n<ul>\n<li><strong>ISO 13485:2016</strong> remains the current edition; ISO/TC 210's 2025 systematic review confirmed it without amendment. Documents written against the 2016 clauses need no edition change.</li>\n<li><strong>FDA QMSR</strong> (21 CFR Part 820, final rule published 2 February 2024) has been <strong>in effect since 2 February 2026</strong>. It incorporates ISO 13485:2016 by reference (plus ISO 9000:2015 clause 3 definitions) and adds FDA-specific requirements: UDI, traceability, MDR reporting, and corrections/removals links (§ 820.10), complaint, servicing, and UDI record content (§ 820.35), and labeling/packaging controls (§ 820.45). The DMR/DHF/DHR terms are gone — their content maps to ISO 13485 clauses 4.2.3 (medical device file), 7.3.10 (design and development file), and 7.5.1 (record per device or batch). Management review, internal audit, and supplier audit records are now open to FDA inspection (the old § 820.180(c) exception was not carried over), and FDA replaced QSIT with the Compliance Program 7382.850 inspection process. An ISO 13485 certificate does not exempt a site from FDA inspection.</li>\n<li><strong>EU MDR/IVDR</strong>: legacy-device transition periods run to 31 Dec 2027 / 31 Dec 2028 under the MDR (Regulation (EU) 2023/607, by risk class and subject to its conditions) and to 31 Dec 2027 / 2028 / 2029 for IVDR classes D / C / B and sterile A (Regulation (EU) 2024/1860). The Commission's December 2025 targeted-revision proposal (COM(2025) 1023) is still in the legislative process and not yet applicable. Check current EUR-Lex text before quoting deadlines.</li>\n</ul>\n<p>See <code>references/quick-reference.md</code> for the regional summary.</p>\n<h2>Core Workflow</h2>\n<h3>1. Assess Current State (Gap Analysis)</h3>\n<p><strong>When to start here:</strong> User has existing documentation and needs to identify gaps</p>\n<p><strong>Process:</strong></p>\n<ol>\n<li><p><strong>Collect existing documentation:</strong></p>\n<ul>\n<li>Ask user to provide directory of current QMS documents</li>\n<li>Documents can be in any format (.txt, .md, .doc, .docx, .pdf)</li>\n<li>Include any procedures, manuals, work instructions, forms</li>\n</ul>\n</li>\n<li><p><strong>Run gap analysis script:</strong></p>\n<pre><code>python scripts/gap_analyzer.py --docs-dir &lt;path_to_docs&gt; --output gap-report.json\n</code></pre>\n</li>\n<li><p><strong>Review results:</strong></p>\n<ul>\n<li>Identify which required procedures are present vs. missing. The script checks the 26 always-applicable documented procedures (it omits the conditional \"when applicable\" ones — design, installation, servicing, sterilization, etc. — to avoid false-negative gaps); the full set is \"31\" by convention. See <code>references/quick-reference.md</code> for the full list and counting note.</li>\n<li>Identify missing key documents (Quality Manual, MDF, etc.)</li>\n<li>Calculate compliance percentage (reported against the 26 procedures the script tracks)</li>\n<li>Prioritize missing documentation, including any conditional procedures that apply to this manufacturer</li>\n</ul>\n</li>\n<li><p><strong>Present findings to user:</strong></p>\n<ul>\n<li>Summarize what exists</li>\n<li>Clearly list what's missing</li>\n<li>Provide prioritized action plan</li>\n<li>Estimate effort required</li>\n</ul>\n</li>\n</ol>\n<p><strong>Output:</strong> Comprehensive gap analysis report with prioritized action items</p>\n<h3>2. Understand Requirements (Reference Consultation)</h3>\n<p><strong>When to use:</strong> User needs to understand specific ISO 13485 requirements</p>\n<p><strong>Available references:</strong></p>\n<ul>\n<li><code>references/iso-13485-requirements.md</code> - Complete clause-by-clause breakdown</li>\n<li><code>references/mandatory-documents.md</code> - All 31 required procedures explained</li>\n<li><code>references/gap-analysis-checklist.md</code> - Detailed compliance checklist</li>\n<li><code>references/quality-manual-guide.md</code> - How to create Quality Manual</li>\n</ul>\n<p><strong>How to use:</strong></p>\n<ol>\n<li><p><strong>For specific clause questions:</strong></p>\n<ul>\n<li>Read relevant section from <code>iso-13485-requirements.md</code></li>\n<li>Explain requirements in plain language</li>\n<li>Provide practical examples</li>\n</ul>\n</li>\n<li><p><strong>For document requirements:</strong></p>\n<ul>\n<li>Consult <code>mandatory-documents.md</code></li>\n<li>Explain what must be documented</li>\n<li>Clarify when documents are applicable vs. excludable</li>\n</ul>\n</li>\n<li><p><strong>For implementation guidance:</strong></p>\n<ul>\n<li>Use <code>quality-manual-guide.md</code> for policy-level documents</li>\n<li>Provide step-by-step creation process</li>\n<li>Show examples of good vs. poor implementation</li>\n</ul>\n</li>\n</ol>\n<p><strong>Key reference sections to know:</strong></p>\n<ul>\n<li><strong>Clause 4:</strong> QMS requirements, documentation, risk management, software validation</li>\n<li><strong>Clause 5:</strong> Management responsibility, quality policy, objectives, management review</li>\n<li><strong>Clause 6:</strong> Resources, competence, training, infrastructure</li>\n<li><strong>Clause 7:</strong> Product realization, design, purchasing, production, traceability</li>\n<li><strong>Clause 8:</strong> Measurement, audits, CAPA, complaints, data analysis</li>\n</ul>\n<h3>3. Create Documentation (Template-Based Generation)</h3>\n<p><strong>When to use:</strong> User needs to create specific QMS documents.</p>\n<p><strong>Available templates:</strong></p>\n<ul>\n<li>Quality Manual: <code>assets/templates/quality-manual-template.md</code></li>\n<li>CAPA Procedure: <code>assets/templates/procedures/CAPA-procedure-template.md</code></li>\n<li>Document Control: <code>assets/templates/procedures/document-control-procedure-template.md</code></li>\n</ul>\n<p>Follow the full creation process, priority order (Phases 1-6), and per-document deep dives (Quality Manual, SOPs, CAPA, Medical Device Files) in <code>references/document-creation-guide.md</code>. That guide also covers the detailed clause-by-clause comprehensive gap analysis.</p>\n<h2>Routing Guidance</h2>\n<ul>\n<li><strong>Gap analysis</strong> (existing docs) → Core Workflow Step 1; run <code>scripts/gap_analyzer.py</code>. Detailed clause-by-clause assessment: <code>references/document-creation-guide.md</code>.</li>\n<li><strong>Understanding a clause/requirement</strong> → Core Workflow Step 2; read <code>references/iso-13485-requirements.md</code> and <code>references/mandatory-documents.md</code>.</li>\n<li><strong>Creating a Quality Manual / SOP / CAPA / MDF</strong> → <code>references/document-creation-guide.md</code> + the matching template in <code>assets/templates/</code>.</li>\n<li><strong>Matching a user situation to an approach</strong> (startup from scratch, existing-QMS gap, single document, QMSR transition, audit prep) → <code>references/common-scenarios.md</code>.</li>\n<li><strong>Writing-quality, exclusions, mistakes to avoid</strong> → <code>references/best-practices.md</code>.</li>\n<li><strong>The 31 procedures, regulatory requirements by region, retention periods</strong> → <code>references/quick-reference.md</code>.</li>\n</ul>\n<h2>References Index</h2>\n<ul>\n<li><code>references/iso-13485-requirements.md</code> — complete ISO 13485:2016 breakdown, clause by clause.</li>\n<li><code>references/mandatory-documents.md</code> — all 31 required procedures plus other mandatory documents, explained.</li>\n<li><code>references/gap-analysis-checklist.md</code> — comprehensive compliance checklist.</li>\n<li><code>references/quality-manual-guide.md</code> — step-by-step guide for a compliant Quality Manual.</li>\n<li><code>references/document-creation-guide.md</code> — full document-creation process, priority order, and per-document deep dives (QM, SOPs, CAPA, MDF, detailed gap analysis).</li>\n<li><code>references/common-scenarios.md</code> — worked approaches for the five most common user situations.</li>\n<li><code>references/best-practices.md</code> — document-development best practices, exclusion rules and examples, common mistakes.</li>\n<li><code>references/quick-reference.md</code> — the 31 procedures, regulatory requirements by region, document retention periods.</li>\n</ul>\n<h3>scripts/</h3>\n<ul>\n<li><code>gap_analyzer.py</code> — automated tool to analyze existing documentation and identify gaps against ISO 13485 requirements.</li>\n</ul>\n<h3>assets/templates/</h3>\n<ul>\n<li><code>quality-manual-template.md</code>, <code>procedures/CAPA-procedure-template.md</code>, <code>procedures/document-control-procedure-template.md</code>.</li>\n</ul>\n<h2>Getting Started</h2>\n<p><strong>First-time users should:</strong></p>\n<ol>\n<li>Read <code>references/iso-13485-requirements.md</code> to understand the standard.</li>\n<li>If you have existing documentation, run the gap analysis script (Core Workflow Step 1).</li>\n<li>Create the Quality Manual using the template and <code>references/document-creation-guide.md</code>.</li>\n<li>Develop procedures in priority order (see the guide).</li>\n<li>Use <code>references/gap-analysis-checklist.md</code> for final validation.</li>\n</ol>\n<p><strong>Need help?</strong> Start by describing your situation: what stage you're at, what you have, and what you need to create — then route via the guidance above.</p>\n<p>Part of the AlterLab Academic Skills suite.</p>\n","files":[{"path":"assets/templates/procedures/CAPA-procedure-template.md","sizeBytes":15055,"isText":true},{"path":"assets/templates/procedures/document-control-procedure-template.md","sizeBytes":18062,"isText":true},{"path":"assets/templates/quality-manual-template.md","sizeBytes":20618,"isText":true},{"path":"evals/evals.json","sizeBytes":6175,"isText":true},{"path":"references/best-practices.md","sizeBytes":2380,"isText":true},{"path":"references/common-scenarios.md","sizeBytes":5539,"isText":true},{"path":"references/document-creation-guide.md","sizeBytes":7318,"isText":true},{"path":"references/gap-analysis-checklist.md","sizeBytes":27586,"isText":true},{"path":"references/iso-13485-requirements.md","sizeBytes":26318,"isText":true},{"path":"references/mandatory-documents.md","sizeBytes":21678,"isText":true},{"path":"references/quality-manual-guide.md","sizeBytes":26208,"isText":true},{"path":"references/quick-reference.md","sizeBytes":3729,"isText":true},{"path":"scripts/gap_analyzer.py","sizeBytes":16033,"isText":true},{"path":"SKILL.md","sizeBytes":10528,"isText":true}],"reviewScore":null,"reviewSummary":null,"trust":{"provenance":"trusted-source-unreviewed","notice":"Community-authored content, reproduced verbatim and not vetted as instructions. 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