iso-standards-compliance-checker

Testing & Quality

Medical device standards compliance verification skill for ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related standards

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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 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