Quality Management

quality-nonconformance is a regulated-manufacturing skill for NCR intake, root cause analysis, CAPA, SPC interpretation, and final disposition. Use it for Compliance Review, supplier quality issues, and evidence-based decisions where traceability, risk, and audit-ready judgment matter.

risk-management-specialist helps AI agents draft ISO 14971:2019 medical device risk work products, including plans, hazard analyses, FMEA tables, risk controls, residual risk summaries, and post-production review inputs. Includes references, templates, and helper scripts for Regulatory Affairs and Quality workflows.

qms-audit-expert is an ISO 13485 internal audit skill for medical device QMS teams. It supports risk-based audit planning, clause checklists, nonconformity classification, CAPA verification, external audit prep, and schedule optimization using included references and a Python tool.

iso13485-audit-prep is a GitHub skill for ISO 13485 QMS compliance review. It pressure-tests DHF, CAPA, complaints, supplier controls, management review, and post-market evidence before audits, MDR/FDA QSR checks, launches, or CAPA follow-up.

fda-qsr-audit-prep is a Compliance Review skill for FDA medical-device QSR audit readiness. Use it to pressure-test complaint files, MDR decisions, CAPA links, process validation, Form 483 responses, and QMSR transition evidence with six inspection-style questions.

postmortem is a single-file executive mentor skill for blameless 5-Whys analysis after failed launches, missed targets, bad hires, or operational breakdowns. It helps define the event, find system causes, and create a change register with owners and follow-up actions.

code-review-and-quality is a structured pre-merge review skill that checks correctness, readability, architecture, security, and performance. Install it from the parent repo, read skills/code-review-and-quality/SKILL.md, and use it with diffs, task context, and test results for stronger review decisions.

iso-13485-certification helps medical device teams prepare ISO 13485:2016 certification documentation. Use it for gap analysis, Quality Manual drafting, required procedures, work instructions, Medical Device File content, and audit prep. It is especially useful for technical writing and certification-ready QMS documentation.