iso-standards-compliance-checker

# ISO Standards Compliance Checker Skill ## Purpose The ISO Standards Compliance Checker Skill verifies medical device compliance with applicable ISO and IEC standards, generating compliance checklists, gap analyses, and evidence mapping for quality management and regulatory submissions. ## Capabilities - Standards applicability determination - Compliance checklist generation - Gap analysis against standard clauses - Evidence mapping to requirements - Harmonized standards cross-reference - Declaration of Conformity assistance - Audit preparation support - Non-conformance tracking - Corrective action recommendations - Standards version comparison - Multi-standard compliance matrices ## Usage Guidelines ### When to Use - 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 Lifecyc...