Agent skill · product strategy · borghei
quality-manager-qms-iso13485
ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support.
Why this skill is useful
Provides specific workflows and scripts for ISO 13485 QMS implementation that the AI wouldn't reliably generate on its own.
What it needs
Requires python installed locally. About 3k tokens when loaded. Last updated 2026-07-21. 462 stars on the source repository.
What this skill does
Quality Manager - QMS ISO 13485 Specialist ISO 13485:2016 Quality Management System implementation, maintenance, and certification support for medical device organizations. Covers the full lifecycle from gap analysis through certification, plus the FDA QMSR transition (effective Feb 2026), digital/electronic QMS, and AI-enabled device considerations. Core Capabilities QMS implementation — gap analysis, Quality Manual (Clause 4.2.2), the 6 mandatory documented procedures, four-tier document hierarchy, certification readiness Document control — numbering conventions, change control, review schedules, electronic document management (eDMS) Internal audit — annual audit programs, individual audit execution, auditor qualification, finding classification (Clause 8.2.4) Process validation — IQ/OQ/PQ protocols, revalidation triggers, special-process examples (Clause 7.5.6) Supplier qualification — A/B/C categorization, scored evaluation, monitoring, software/cloud provider assessment (Clause 7.4) Cross-framework integration — FDA QMSR, 21 CFR Part 11 / EU Annex 11, ISO 42001 (AI), remote/hybrid audits, cybersecurity-driven CAPA When to Use Building an ISO 13485:2016 QMS from scratch or remediating gaps Preparing for or transitioning to the FDA QMSR Establishing document control, internal audit, validation, or supplier programs Modernizing to a digital/electronic QMS (Part 11 / Annex 11) Integrating AI-enabled device or cybersecurity requirements into the QMS Clarify First Before building or assessing the QMS, confirm these inputs. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills borghei/quality-manager-qms-iso13485