Looking for templates or forms to use in your quality system?

DOWNLOADABLE TEMPLATES

Follow the links below to access Archimedic's templates

Archimedic follows the ISO 13485 framework for developing Quality documents. Most documents will fall under either the Product Realization section or the Measurement, Analysis and Improvement section within the standard.

Product Realization Templates:

Design History File (DHF) Index

User Needs

Risk Management Plan

Risk Hazard Analysis

Risk Management Report

Use Related Risk Analysis

Usability Study Protocol

Usability Study Consent Form

Human Factors Report

Instructions for Use

Work Instructions

Bill of Materials 

Inspection Procedure

Inspection Form

Rework Form

Purchase Order Form

Engineering Drawing

Characterization Test Protocol

Measurement, Analysis & Improvement Templates:

Complaint Form

Returned Goods Authorization (RGA)

Nonconforming Material Report

Corrective Action/Preventive Action (CAPA)

Supplier Corrective Action Report (SCAR)