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iso-standards-compliance-checker skill

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This skill helps verify medical device compliance with ISO/IEC standards by generating checklists, gap analyses, and evidence mappings for regulatory

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---
name: iso-standards-compliance-checker
description: Medical device standards compliance verification skill for ISO 13485, ISO 14971, IEC 62304, IEC 60601, and related standards
allowed-tools:
  - Read
  - Write
  - Glob
  - Grep
  - Edit
  - Bash
metadata:
  specialization: biomedical-engineering
  domain: science
  category: Regulatory Compliance
  skill-id: BME-SK-003
---

# 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

```yaml
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

Overview

This skill verifies medical device compliance with ISO and IEC standards, focusing on ISO 13485, ISO 14971, IEC 62304, IEC 60601 and related standards. It produces applicability matrices, compliance checklists, gap analyses, and evidence maps to support audits and regulatory submissions. The outputs are designed to streamline audit preparation and drive corrective actions where gaps are found.

How this skill works

The skill inspects device type, intended use, available QMS and design documentation, and selected regulatory pathways to determine applicable standards and clauses. It generates checklists and gap analyses by comparing documented evidence to clause requirements, maps evidence to requirements, and suggests corrective actions and declaration templates. It can compare standard versions and produce multi-standard compliance matrices for integrated reviews.

When to use it

Setting up or improving a medical device quality management system
Preparing for certification audits or regulatory submissions
Performing internal compliance reviews or gap assessments
Mapping design and development evidence to regulatory requirements
Integrating risk management and software lifecycle compliance checks

Best practices

Identify applicable standards and harmonized guidance early in development
Keep standard versions and regulatory guidance up to date in the compliance dataset
Organize and tag evidence to match clause-level requirements for faster mapping
Run periodic internal reviews and update checklists after design changes
Use generated gap analyses to drive prioritized corrective actions and track closure

Example use cases

Produce a standards applicability matrix for a new active medical device and identify mandatory clauses
Generate a clause-level gap analysis before a certification audit to focus remediation effort
Map test reports, design inputs and risk assessments to ISO 13485 and IEC 62304 clauses for a regulatory submission
Compare two versions of IEC 62304 to see changes affecting software lifecycle obligations
Create a Declaration of Conformity draft and an audit preparation package with checklists and evidence references

FAQ

What inputs does the skill need to start an assessment?

Provide device type, intended use, selected regulatory pathways, and available QMS, design, verification and risk documentation.

Can it handle multiple standards at once?

Yes. It produces multi-standard matrices and cross-references harmonized standards and clauses across ISO and IEC families.