What document control standards does it support?

It defines a standardized hierarchy of documents (Quality Manual, SOPs, WIs, Records) and provides a specific numbering convention to meet Clause 4.2.3 requirements.

How does this skill assist with ISO 13485 audits?

It provides a complete internal audit workflow, including planning templates, finding classification guides (Major vs. Minor NC), and auditor qualification requirements to ensure your system is audit-ready.

Does it help with supplier management?

It includes a framework for supplier qualification, including risk-based categorization (Category A, B, C) and weighted evaluation criteria for performance monitoring.

Can I use this for process validation documentation?

Yes, the skill includes detailed workflows for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) specifically for special processes like sterilization.

Is this skill suitable for initial QMS implementation?

Absolutely. It features a dedicated implementation workflow starting from gap analysis through the creation of mandatory documented procedures and management review setup.

Quality Manager ISO 13485 QMS

Name: Quality Manager ISO 13485 QMS
Author: zhangzhang-111-i

byzhangzhang-111-i

0•

생산성 및 워크플로

Implements and maintains ISO 13485:2016 Quality Management Systems for medical device regulatory compliance and certification.

This skill serves as a comprehensive guide for medical device organizations to establish, maintain, and improve their Quality Management Systems (QMS) in alignment with ISO 13485:2016. It provides structured workflows for gap analysis, document control, internal auditing, process validation (IQ/OQ/PQ), and supplier qualification. Whether you are building a QMS from scratch, preparing for a certification audit, or managing corrective and preventive actions (CAPA), this skill provides the domain-specific frameworks and documentation standards required for strict regulatory compliance.

주요 기능

010 GitHub stars

02Comprehensive internal audit workflows including finding classification and reporting templates.

03Detailed process validation protocols for sterilization, welding, and other special processes.

04Supplier qualification and performance monitoring metrics based on risk categorization.

05Standardized document control systems with numbering conventions and approval hierarchies.

06Step-by-step QMS implementation roadmap and gap analysis framework.

사용 사례

01Preparing for an ISO 13485:2016 certification or surveillance audit.

02Designing a supplier management program for critical medical device components.

03Establishing a compliant document control and records management system.

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 quality-manager-qms-iso13485

For use in Claude.ai and ChatGPT

주요 기능

010 GitHub stars

02Comprehensive internal audit workflows including finding classification and reporting templates.

03Detailed process validation protocols for sterilization, welding, and other special processes.

04Supplier qualification and performance monitoring metrics based on risk categorization.

05Standardized document control systems with numbering conventions and approval hierarchies.

06Step-by-step QMS implementation roadmap and gap analysis framework.

사용 사례

01Preparing for an ISO 13485:2016 certification or surveillance audit.

02Designing a supplier management program for critical medical device components.

03Establishing a compliant document control and records management system.

What are Skills?·How to Install

Install with 🐟 Skill.Fish

npx skillfish add zhangzhang-111-i/claude-skills111 quality-manager-qms-iso13485

For use in Claude.ai and ChatGPT