ISO 13485 Forms Package

This package of ISO 13485 Forms is a complete set of forms and tables for you to use with your 13485 Quality Management System. They are in Microsoft Word and Excel format and are ready to customize for your organization.

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The package of 32 forms includes:

Document Master List

Software Inventory

Document Change Request Form

Document Revision Checklist

Quality Records Table

QMS Measuring, Monitoring and Analysis Table

Key Process Master List

Training Action Plan

Group Training Record

Training Spreadsheet

Planning Table

Design Plan

Design Review Record

Design Change

Supplier Quality Report

SCAR

Approved Supplier List

Equipment List

Internal Audit Plan

Internal Audit Report

Applicable Procedure by Work Area

Audit Checklist

Product Realization Monitoring, Measuring and Analysis Table

Corrective/Preventive Action Request

A-500 QP

Risk Management Plan

Risk List

Procedure Template

Work instruction Temp

Form Temp