Does it support process validation for manufacturing?

Yes, it includes detailed workflows and protocol requirements for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

How does it handle supplier qualification?

It features a complete supplier qualification workflow, including risk categorization (A/B/C), evaluation scoring criteria, and performance monitoring metrics.

Can I use this for CAPA management?

Absolutely. It includes specific procedures for identifying root causes, implementing corrective actions, and verifying effectiveness according to Clause 8.5.2.

Does this skill help with ISO 13485:2016 certification?

Yes, it provides the necessary workflows, documentation structures, and gap analysis tools required to prepare for and maintain ISO 13485:2016 certification.

ISO 13485 QMS Quality Manager

Name: ISO 13485 QMS Quality Manager
Author: borghei

byborghei

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Learning & Documentation

Implements and maintains ISO 13485 Quality Management Systems for medical device organizations through guided documentation and audit workflows.

The ISO 13485 QMS Quality Manager skill provides a comprehensive framework for medical device companies to achieve and maintain regulatory compliance. It automates complex quality management tasks including gap analysis, document control numbering, internal audit scheduling, and process validation protocols (IQ/OQ/PQ). By streamlining CAPA management and supplier qualification, this skill ensures organizations meet the rigorous standards required for ISO 13485:2016 certification and product safety while maintaining high engineering and manufacturing standards.

Key Features

01Full Process Validation (IQ/OQ/PQ) protocols for specialized manufacturing

0250 GitHub stars

03Comprehensive Gap Analysis against ISO 13485:2016 requirements

04Supplier Qualification and risk-based performance monitoring frameworks

05Internal Audit planning, execution, and finding classification workflows

06Standardized Document Control system with automated numbering conventions

Use Cases

01Drafting compliant SOPs, Work Instructions, and Quality Manuals for medical device production

02Preparing for an initial ISO 13485:2016 certification audit from gap analysis to final documentation

03Managing recurring internal audits and tracking Corrective and Preventive Actions (CAPA)

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add borghei/claude-skills quality-manager-qms-iso13485

For use in Claude.ai and ChatGPT

Download Skill