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. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.

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저장소: alirezarezvani/claude-skills
최근 소스 활동: 2026년 6월 11일 15:59
감지된 SKILL.md 언어: 영어
스타: 24,525
포크: 3,442

설치 방법

기본적으로 소스를 먼저 확인하는 Prompt가 선택됩니다. 직접 명령으로 전환하거나 로컬 사본을 다운로드할 수도 있습니다.

Codex 또는 Claude로 설치 이 Prompt를 복사해 Codex, Claude 또는 다른 어시스턴트에 붙여 넣으면 Skill 페이지를 검토하고 설치를 진행할 수 있습니다.

직접 명령은 검토 Prompt를 거치지 않습니다. 실행하기 전에 소스를 확인하세요.

npx skills add https://github.com/alirezarezvani/claude-skills --skill quality-manager-qms-iso13485

명령은 한 줄로 유지됩니다. 복사하기 전에 가로로 스크롤해 전체 내용을 확인하세요.

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SKILL.md

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meetings

Use when someone wants to decide whether a meeting is worth calling, price a meeting in dollars, build a timeboxed agenda with desired outcomes, or turn messy meeting notes into owned action items — or says "should this be a meeting", "/cs:meeting-prep", or "/cs:meeting-actions". Runs a cost gate (ASYNC / NOT-READY / MEET), builds a decision-first agenda, and extracts an owner + due-date checklist that flags every orphan.

2026-07-17

deep-work

Use when someone wants to plan a deep work day, time-block their calendar or task list, budget or cut shallow work, protect focus hours, track deep-work sessions and streaks, run an end-of-day shutdown ritual, or says "/deep-work" or "/time-block". Classifies tasks deep vs shallow, builds an energy-first time-blocked schedule that refuses deep demand past the 4-hour ceiling, batches shallow work into at most two windows, and logs focus sessions against a weekly target.

2026-07-17

agent-harness

Turn any domain folder of skills into a bounded agentic loop: compile a goal into a verifiable task plan, execute tasks with the domain's own tools, verify every task with machine-run checks, retry with caps, escalate to a human when budgets exhaust, and refuse to close until everything is verified or explicitly waived. Use when you want an agent or subagent to pick up a goal and drive it to a verified close across one of this repo's 18 domains ('run this goal through the engineering harness', 'set up an agentic loop for marketing work', 'make the finance domain self-verifying'). NOT for authoring Claude Code Workflow-tool .js scripts (workflow-builder), N-agent tournaments on one task (agenthub), single-file metric optimization (autoresearch-agent), or discovering published loop recipes (loop-library).

2026-07-17

이 저장소의 모든 Skills 보기

name	quality-manager-qms-iso13485
description	ISO 13485 Quality Management System implementation and maintenance for medical device organizations. Provides QMS design, documentation control, internal auditing, CAPA management, and certification support. Use when working with medical device quality systems, preparing for ISO 13485 audits, managing regulatory compliance documentation, setting up corrective actions, or building audit preparation programs. Useful for quality management, audit preparation, regulatory compliance, medical device documentation, and corrective action workflows.
triggers	["ISO 13485","QMS implementation","quality management system","document control","internal audit","management review","quality manual","CAPA process","process validation","design control","supplier qualification","quality records"]