Results for “quality-manual”

Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2 for HealthTech and MedTech companies.

Use before delivering any documentation to validate quality, accuracy, and completeness. This skill provides a checklist for reviewing all documentation deliverables to ensure they meet minimum quality standards before distribution.

Validate SKILL.md files against a quality rubric, scoring schema and instruction structure out of 100 and reporting a pass/fail verdict with specific fixes.

Build and review high-quality technical documentation, including agent instruction files and contributor-governance files, with support for audits, multilingual parity, and sub-agent orchestration.

Provides ISO 13485 internal audit methodology for medical device quality management systems, covering audit planning, execution, nonconformity classification, and external audit preparation.