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.

الانتقال إلى التثبيت

المستودع: alirezarezvani/claude-skills
آخر نشاط في المصدر: ١١ يونيو ٢٠٢٦ في ١٥:٥٩
لغة SKILL.md المكتشفة: الإنجليزية
النجوم: ٢٤٬٥٢٥
التفرعات: ٣٬٤٤٢

خيارات التثبيت

يُحدَّد Prompt الذي يراجع المصدر أولًا بشكل افتراضي. يمكنك التبديل إلى أمر مباشر أو تنزيل نسخة محلية.

التثبيت باستخدام Codex أو Claude انسخ هذا Prompt والصقه في Codex أو Claude أو مساعد آخر ليراجع صفحة Skill ويثبّتها لك.

يتجاوز الأمر المباشر Prompt المخصّص للمراجعة. افحص المصدر قبل تشغيله.

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

يبقى الأمر في سطر واحد. مرّر أفقيًا لمراجعته كاملًا قبل النسخ.

تفضّل نسخة محلية؟ نزّل الملفات المتاحة حاليًا لدى SkillsMP.

مراجعة ملفات المصدر

اقرأ SKILL.md وأي ملفات مرافقة يعرضها SkillsMP قبل أن تقرر التثبيت.

مستكشف الملفات

4 ملفات

SKILL.md

تعليمات المصدر · معاينة للقراءة فقط

العودة إلى البحث العودة إلى التثبيت

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

عرض الكل من هذا المستودع

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"]