Iso Standards Compliance Checker

• Implementing quality management systems
• Preparing for certification audits
• Conducting internal compliance reviews
• Supporting regulatory submissions

Prerequisites

• Device type and intended use defined
• Applicable regulatory pathways identified
• Quality management system documentation available
• Design and development records accessible

Best Practices

• Identify all applicable standards early in development
• Maintain current knowledge of standards revisions
• Document compliance evidence systematically
• Conduct regular internal compliance reviews

Process Integration

This skill integrates with the following processes:

• Design Control Process Implementation
• Medical Device Risk Management (ISO 14971)
• Software Development Lifecycle (IEC 62304)
• EU MDR Technical Documentation

Dependencies

• ISO standards database
• FDA recognized consensus standards list
• Harmonized standards registry
• Standards development organization publications
• Regulatory guidance documents

Configuration

iso-standards-compliance-checker:
  standards-families:
    - ISO-13485
    - ISO-14971
    - IEC-62304
    - IEC-60601
    - ISO-10993
    - ISO-11135
    - ISO-11137
    - ISO-11607
  compliance-levels:
    - full
    - partial
    - not-applicable
  output-formats:
    - checklist
    - gap-analysis
    - evidence-matrix

Output Artifacts

• Standards applicability matrices
• Compliance checklists by standard
• Gap analysis reports
• Evidence mapping documents
• Declaration of Conformity templates
• Audit preparation packages
• Non-conformance logs
• Corrective action recommendations

Quality Criteria

• All applicable standards identified correctly
• Checklists reflect current standard versions
• Gap analysis is comprehensive and actionable
• Evidence mapping supports audit review
• Documentation maintains regulatory acceptance
• Compliance status accurately reported