ISO 13485 QMS Gap Diagnostic

Problem it addresses

Many medical device teams preparing for ISO 13485 certification do not simply lack documents; they do not know which gaps will become major nonconformities. Common issues include uncontrolled quality manuals, no appointed management representative, internal audits not closed out, CAPA records that state actions but never verify root causes, incomplete design history files, supplier evaluation without performance evidence, sterilization validation with OQ but no PQ, and unclear CE vigilance or clinical evaluation pathways. This skill turns scattered internal rules into a clause-by-clause gap view across chapters 4 to 8, so teams stop answering auditors with "we probably have it."

How the skill works

After taking product type, company scale, design involvement, sterilization, cleanroom use, target market, and target date, it checks the standard section by section:
- Chapter 4: QM, procedures, document control, record retention
- Chapter 5: management representative, management review, quality policy and objectives
- Chapter 7: 7.3 design controls, supplier ABC classification, batch records DHR, sterilization IQ/OQ/PQ
- Chapter 8: internal audit, CAPA, nonconforming product control, customer feedback, and data analysis

The output lists clause, current state, gap, severity, corrective action, and P0/P1/P2 priority, then proposes a certification timeline. For EU targets, it also checks CE technical documentation, vigilance reporting, advice reports, labeling language, and clinical evaluation routes.

Boundaries

It is useful for greenfield QMS buildout, gap remediation, and pre-audit mock checks. It does not replace notified-body audits, formal regulatory advice, or actual sterilization validation execution. The diagnosis is only as specific as the product, documents, operating records, and market scope you provide; a generic request such as "we want certification" will only yield a generic checklist, not an enterprise-specific risk assessment.