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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Repositório: alirezarezvani/claude-skills
Última atividade na origem: 11 de junho de 2026 às 15:59
Idioma detectado do SKILL.md: inglês
Estrelas: 24.525
Forks: 3.442

Opções de instalação

Por padrão, está selecionado o prompt que primeiro revisa a origem. Você pode mudar para um comando direto ou baixar uma cópia local.

Instalar com Codex ou Claude Copie este prompt, cole no Codex, Claude ou outro assistente e deixe que ele revise a página da skill e instale para você.

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

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Prefere uma cópia local? Baixe os arquivos disponíveis atualmente no SkillsMP.

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4 arquivos

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

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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"]