ISO 13485 Certification

1. Assess Current State (Gap Analysis)

When to start here: User has existing documentation and needs to identify gaps

Process:

1. Collect existing documentation:

   • Ask user to provide directory of current QMS documents
   • Documents can be in any format (.txt, .md, .doc, .docx, .pdf)
   • Include any procedures, manuals, work instructions, forms

2. Run gap analysis script:

3. Review results:

   • Identify which of the 31 required procedures are present
   • Identify missing key documents (Quality Manual, MDF, etc.)
   • Calculate compliance percentage
   • Prioritize missing documentation

4. Present findings to user:

   • Summarize what exists
   • Clearly list what's missing
   • Provide prioritized action plan
   • Estimate effort required

Output: Comprehensive gap analysis report with prioritized action items

2. Understand Requirements (Reference Consultation)

When to use: User needs to understand specific ISO 13485 requirements

Available references:

• references/iso-13485-requirements.md - Complete clause-by-clause breakdown
• references/mandatory-documents.md - All 31 required procedures explained
• references/gap-analysis-checklist.md - Detailed compliance checklist
• references/quality-manual-guide.md - How to create Quality Manual

How to use:

1. For specific clause questions:

   • Read relevant section from iso-13485-requirements.md
   • Explain requirements in plain language
   • Provide practical examples

2. For document requirements:

   • Consult mandatory-documents.md
   • Explain what must be documented
   • Clarify when documents are applicable vs. excludable

3. For implementation guidance:

   • Use quality-manual-guide.md for policy-level documents
   • Provide step-by-step creation process
   • Show examples of good vs. poor implementation

Key reference sections to know:

• Clause 4: QMS requirements, documentation, risk management, software validation
• Clause 5: Management responsibility, quality policy, objectives, management review
• Clause 6: Resources, competence, training, infrastructure
• Clause 7: Product realization, design, purchasing, production, traceability
• Clause 8: Measurement, audits, CAPA, complaints, data analysis