Quality Manager Qms Iso13485
Map ISO 13485:2016 clause requirements, implementation evidence, and audit questions for medical-device quality management.
Overview
Quality Manager QMS ISO 13485 is an agent skill most often used in Validate (also Ship security, Operate iterate) that translates ISO 13485:2016 clauses into implementation guidance, evidence, and audit questions for med
Install
npx skills add https://github.com/alirezarezvani/claude-skills --skill quality-manager-qms-iso13485What is this skill?
- Structured coverage of ISO 13485:2016 Clauses 4–8 with implementation and evidence columns
- Per-requirement audit questions for QMS processes, management responsibility, and product realization
- Clause 7 product-realization detail for design controls aligned with medical software teams
- Measurement, analysis, and improvement (Clause 8) tied to CAPA and performance evidence
- ISO 13485:2016 clauses 4 through 8 organized with requirement, implementation, and evidence tables
Adoption & trust: 731 installs on skills.sh; 17.5k GitHub stars; 2/3 security scanners passed (skills.sh audits).
What problem does it solve?
You are building regulated health software but lack a clause-by-clause view of what ISO 13485 expects for processes, records, and audit defense.
Who is it for?
Indie or small medtech/SaMD teams pre-audit who need ISO 13485 clause checklists while drafting QMS procedures and design controls.
Skip if: General SaaS with no medical device intent, or teams seeking FDA-only QSR text without ISO 13485 alignment.
When should I use this skill?
Drafting or reviewing ISO 13485 QMS coverage, audit prep, or medical product realization documentation.
What do I get? / Deliverables
You get structured clause requirements with implementation hints, evidence types, and audit questions to scope QMS documentation and gap remediation plans.
- Clause-aligned gap analysis outline
- Audit question bank by clause
- Evidence checklist mapped to ISO 13485 requirements
Recommended Skills
Journey fit
Spans multiple journey phases - primary shelf plus alternate fits below.
Regulatory scope and QMS process design must be settled in Validate before capital-intensive Build and Ship for regulated software. Clause-level tables (4–8) help define what processes, records, and CAPAs must exist before you commit to a compliant product path.
Where it fits
Decide which ISO 13485 clauses apply to your software-only device and list mandatory documented procedures.
Estimate compliance overhead (training, audits, DHF) before committing to a regulated market entry.
Cross-check design and risk outputs against Clause 7 realization requirements before release.
Frame CAPAs and trend analysis for Clause 8 after post-market feedback or audit findings.
How it compares
Use instead of ad-hoc ChatGPT summaries of ISO 13485 when you need tabular requirement-to-evidence mapping suitable for quality managers.
Common Questions / FAQ
Who is quality-manager-qms-iso13485 for?
Solo builders, startup quality leads, and technical founders in medical devices or SaMD who own or draft QMS documentation against ISO 13485:2016.
When should I use quality-manager-qms-iso13485?
In Validate scope when deciding regulatory path; in Ship security when aligning design controls and records; in Operate iterate when preparing CAPAs and audit evidence.
Is quality-manager-qms-iso13485 safe to install?
Review the Security Audits panel on this Prism page and treat outputs as regulatory drafting aids that still require human qualified review.
SKILL.md
READMESKILL.md - Quality Manager Qms Iso13485
# ISO 13485:2016 Clause Requirements Detailed requirements for each ISO 13485:2016 clause with implementation guidance and audit criteria. --- ## Table of Contents - [Clause 4: Quality Management System](#clause-4-quality-management-system) - [Clause 5: Management Responsibility](#clause-5-management-responsibility) - [Clause 6: Resource Management](#clause-6-resource-management) - [Clause 7: Product Realization](#clause-7-product-realization) - [Clause 8: Measurement, Analysis and Improvement](#clause-8-measurement-analysis-and-improvement) --- ## Clause 4: Quality Management System ### 4.1 General Requirements | Requirement | Implementation | Evidence | |-------------|----------------|----------| | Determine processes needed | Process map showing QMS processes | Documented process map | | Determine sequence and interaction | Process interaction diagram | Cross-reference matrix | | Determine criteria for operation | Process metrics and acceptance criteria | Documented criteria per process | | Ensure resources available | Resource allocation per process | Training records, equipment logs | | Monitor, measure, analyze | Process monitoring procedures | Trend data, performance reports | | Implement actions for results | Improvement projects, CAPAs | Action records with verification | | Document processes | Procedures, work instructions | Controlled document list | **Audit Questions:** - How are QMS processes identified and documented? - What criteria determine if processes are operating effectively? - How is outsourced process control demonstrated? ### 4.2 Documentation Requirements #### 4.2.1 General | Document Type | Requirement | Retention | |---------------|-------------|-----------| | Quality Policy | Documented statement of commitment | Life of QMS | | Quality Objectives | Measurable objectives at relevant functions | Life of QMS | | Quality Manual | QMS scope and processes | Current version | | Documented Procedures | Required by standard | Life of QMS + 2 years | | Records | Evidence of conformity | As defined per record type | #### 4.2.2 Quality Manual **Required Content:** 1. Scope of QMS including justification for exclusions 2. Documented procedures or reference to them 3. Description of process interactions **Quality Manual Template Structure:** ``` QUALITY MANUAL 1. Company Overview 1.1 Company Description 1.2 Scope of QMS 1.3 Exclusions and Justification 2. Quality Policy 3. Quality Objectives 4. QMS Structure 4.1 Process Map 4.2 Process Interactions 4.3 Organizational Chart 5. Procedure References 5.1 Document Control 5.2 Record Control 5.3 Management Review 5.4 Internal Audit 5.5 Nonconformity Control 5.6 CAPA 6. Appendices 6.1 Glossary 6.2 Regulatory Cross-Reference ``` #### 4.2.3 Control of Documents | Control Element | Requirement | Method | |-----------------|-------------|--------| | Approval | Adequate prior to issue | Signature/electronic approval | | Review and update | Re-approval after changes | Periodic review process | | Identification of changes | Change history visible | Revision log in document | | Revision status | Current revision identifiable | Document master list | | Legibility | Readable and identifiable | Format standards | | External documents | Identified and controlled | Incoming document log | | Obsolete documents | Prevented from unintended use | Archive system | **Document Numbering Convention:** ``` [TYPE]-[AREA]-[SEQUENCE]-[REV] TYPE: QM = Quality Manual SOP = Standard Operating Procedure WI = Work Instruction TF = Template/Form POL = Policy AREA: 01 = Quality Management 02 = Document Control 03 = Training 04 = Design 05 = Purchasing 06 = Production 07 = Quality Control 08 = CAPA Example: SOP-02-001-03 = Document Control SOP, Revision 03 ``` #### 4.2.4 Control of Records | Record Category | Minimum Retention | Basis | |-----------------|-------------------|-------| | Device Master Record | L