Is it updated for ISO 13485:2016?

Yes, all workflows and clause references are designed specifically to meet the requirements of the ISO 13485:2016 standard.

Can this skill help with initial ISO 13485 certification?

Yes, it includes a gap analysis workflow and implementation roadmap to guide organizations from initial assessment to certification readiness.

Can it assist with supplier management?

Yes, it offers a framework for supplier categorization, qualification scoring, and ongoing performance monitoring based on component criticality.

Does it support document control requirements?

Absolutely. It provides standardized numbering conventions, approval hierarchies, and review schedules for all levels of QMS documentation.

How does it handle process validation?

It provides structured workflows for IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), including identification of special processes like sterilization.

Quality Manager (ISO 13485)

Name: Quality Manager (ISO 13485)
Author: zhangzhang-111-i

byzhangzhang-111-i

0•

Productividad y Flujo de Trabajo

Implements and manages ISO 13485 Quality Management Systems for medical device organizations to ensure regulatory compliance.

This skill provides a comprehensive framework for medical device companies to establish, maintain, and audit their Quality Management System (QMS) in accordance with ISO 13485:2016. It offers standardized workflows for document control, CAPA management, internal auditing, and process validation (IQ/OQ/PQ), streamlining the path to certification and ensuring continuous regulatory compliance. It acts as a digital quality specialist, guiding users through gap analysis, supplier qualification, and management review preparation to maintain high standards of product safety and efficacy.

Características Principales

01Risk-based supplier qualification and performance monitoring

02Structured internal audit planning and finding classification

03ISO 13485:2016 gap analysis and implementation roadmaps

04Process validation (IQ/OQ/PQ) protocol and report generation

050 GitHub stars

06Automated document control and numbering workflows

Casos de Uso

01Preparing for an upcoming ISO 13485 certification or surveillance audit

02Conducting and documenting internal audits and corrective actions (CAPA)

03Establishing a compliant document control system for a new medical device startup

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

Características Principales

01Risk-based supplier qualification and performance monitoring

02Structured internal audit planning and finding classification

03ISO 13485:2016 gap analysis and implementation roadmaps

04Process validation (IQ/OQ/PQ) protocol and report generation

050 GitHub stars

06Automated document control and numbering workflows

Casos de Uso

01Preparing for an upcoming ISO 13485 certification or surveillance audit

02Conducting and documenting internal audits and corrective actions (CAPA)

03Establishing a compliant document control system for a new medical device startup

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