iso-13485-certification
Prepare ISO 13485 certification documentation
Medical device companies need comprehensive ISO 13485 documentation for quality management certification. This skill provides templates, gap analysis tools, and step-by-step guidance to create all required QMS documents efficiently.
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Using "iso-13485-certification". What procedures do we need for ISO 13485 certification?
Expected outcome:
- ISO 13485 requires 31 documented procedures including: Control of Documents, Control of Records, Management Review, Training and Competence, Purchasing, Production Control, Complaint Handling, Internal Audit, CAPA, and Control of Nonconforming Product
- Additional conditional procedures apply based on your specific operations such as Design and Development, Installation, Servicing, Sterilization, and Process Validation
- Your Quality Manual must reference all procedures and describe process interactions
Using "iso-13485-certification". How do we transition from FDA QSR to QMSR?
Expected outcome:
- FDA QMSR harmonization (effective February 2026) requires updating references from 21 CFR Part 820 to align with ISO 13485 clauses
- Key changes: Consolidate DHF, DMR, and DHR into a single Medical Device File structure
- Update your Quality Manual to reference QMSR requirements and maintain backward compatibility during transition
Security Audit
SafeAll 416 static findings are false positives. The scanner misinterpreted documentation keywords in markdown templates as security issues (e.g., 'SAM' as Windows Security Accounts Manager, cryptographic terms in QMS documentation). This is a legitimate ISO 13485 documentation toolkit containing templates and a local Python analysis script with no network access or credential handling.
Risk Factors
📁 Filesystem access (1)
Quality Score
What You Can Build
Build QMS from scratch
New medical device companies creating their first ISO 13485 quality management system documentation package
Conduct gap analysis
Quality professionals assessing existing documentation against ISO 13485 requirements before certification audit
Update for QMSR transition
Teams updating FDA QSR documentation to align with new QMSR harmonization requirements
Try These Prompts
Help me understand ISO 13485 requirements and where to start with documentation for our medical device company
Analyze our QMS documentation and identify gaps against ISO 13485 requirements
Help me create a CAPA (Corrective and Preventive Action) procedure for our quality management system
Prepare our documentation for ISO 13485 certification audit and identify any final gaps
Best Practices
- Start with policy-level documents (Quality Manual, Quality Policy) before creating detailed procedures
- Cross-reference related documents to ensure consistency across your QMS documentation
- Prioritize critical documents first: CAPA, Complaint Handling, Internal Audit, and Management Review
Avoid
- Copying ISO 13485 standard text verbatim instead of describing your actual processes
- Creating overly detailed procedures that belong in work instructions instead
- Neglecting to maintain records that demonstrate QMS implementation