close
lumiform
Lumiform Mobile audits & inspections
Get App Get App
Overview
Get an overview of the most important features in Lumiform.
Form builder
Create custom checklists and use logics to predefine workflows.
Mobile app
Quickly conduct inspections with the easy-to-use inspection app.
Issue resolution
Turn issues into corrective actions by collaborating with team members.
Results, reports & analytics
Share automatically generated reports and get in-depth analytics.
Administration
Easily adapt the Lumiform software to your complex organization structure.
Book a personal demo
Contact sales
By category
Cleaning Food Safety ISO Maintenance Quality Assurance Risk Assessment Workplace Safety View all templates
By industry
Hospitality Management Manufacturing Transport and Logistics Construction Retail Facility Management Health Care
Book a personal demo
Contact sales
By app use
Energy Audit App Quality Management System App Commercial cleaning app: simplify scheduling, tracking, and management! Free Daily Forklift Inspection App Vehicle Inspection App Mystery Shopper App View all app uses
By industry
Food & Hospitality Construction Manufacturing Retail Logistic & Transportation Facility Management Pharma & Chemistry View all industries
Book a personal demo
Contact sales
Checklists
5S Checklist Mystery Shopper Checklist BRC Audit Checklist Incoming Goods Inspection Checklist Safety Observation Report Checklist Restaurant Checklists for Standard Operating Procedure Social Worker Home Visit Checklist View all checklists
Guides
What is 5s in your company? Understanding ISO What Is ISO 9001? What is Kanban? What is Poka Yoke? What is the CE Marking? Child Care Observation Guide View all guides
Knowledge hub
Customer success stories
How businesses are using Lumiform successfully.
Infographics
A combination of data, facts or timelines with graphics for clear, visual hubs of information.
Videos
How to videos, demos and much more.
 
Help center
Get helpful tips on how to use Lumiform features.
FAQ
Take a look at frequently asked questions.
Lexicon
A glossary of all technical terms.
Book a personal demo
Contact sales

ISO 13485 supplier audit checklist

Downloaded 0 times
Page 1
General Information
Supplier Name
Audit Date
Auditor Name
Quality Management System
Supplier has a documented quality management system
Quality manual is available and current
Quality policy is defined and communicated
Quality objectives are established
Management reviews are conducted
Corrective and preventive actions are implemented
Control of Documents and Records
Procedure for document control is established
Procedure for record control is established
Documents and records are legible and identifiable
Document changes are reviewed and approved
Records are stored and protected
Resource Management
Personnel are competent and trained
Infrastructure is suitable for operations
Work environment is controlled
Product Realization
Planning of product realization is established
Customer requirements are determined and met
Design and development is planned and controlled
Purchasing process is controlled
Production and service provision is controlled
Verification, validation, monitoring, measurement, inspection and test activities are established
Nonconforming product is identified and controlled
Measurement, Analysis and Improvement
Internal audits are conducted
Monitoring and measurement of processes and product is established
Analysis of data is performed to demonstrate suitability and effectiveness of the QMS
Improvement activities are implemented
Share this template:

Related Categories:

Related Checklists:

Ensuring compliance with ISO 13485 standards is crucial for maintaining a safe and efficient supplier management process. Our ISO 13485 supplier audit checklist template is designed to help you conduct thorough inspections, identify potential hazards, and ensure compliance with ISO 13485 regulations. By using this template, you can create a safer workplace and promote a culture of quality within your organization. Make your supplier management safer and more efficient with our easy-to-use checklist.  

Enhance your company’s reputation for quality and ensure compliance with ISO 13485 regulations.

  The primary purpose of our ISO 13485 supplier audit checklist template is to provide a structured and systematic approach to inspections that aligns with ISO 13485 regulations. This template helps you identify and address potential hazards before they escalate into serious issues, ensuring a safer work environment.   By using this checklist, you can streamline your inspections, promote a culture of quality, and reduce the risk of nonconformities in your supplier management process. Additionally, it helps ensure compliance with ISO 13485 regulations, which can prevent costly fines and enhance your company’s reputation for quality. Ultimately, this template supports the creation of a proactive quality culture, leading to improved employee morale and productivity. A safer supplier management process means happier employees and better operational efficiency.  

Key elements of the ISO 13485 supplier audit checklist template

  Our ISO 13485 supplier audit checklist template includes several key elements to ensure comprehensive inspections. It covers critical areas such as:  
  • Quality management system: Verify that the supplier has a documented quality management system and that it meets the requirements of ISO 13485. Check if the quality manual is available and current, the quality policy is defined and communicated, and quality objectives are established.
  • Management responsibility: Assess the commitment of top management to the quality management system. Check if management reviews are conducted periodically and if corrective and preventive actions are implemented effectively.
  • Control of documents and records: Ensure that procedures for document control and record control are established. Verify that documents and records are legible, identifiable, and stored securely. Confirm that document changes are reviewed and approved appropriately.
  • Resource management: Ensure that personnel are competent and trained, the infrastructure is suitable for operations, and the work environment is controlled to meet product requirements.
  • Product realization: Confirm that planning of product realization is established, customer requirements are determined and met, and design and development processes are planned and controlled. Verify that the purchasing process is controlled, production and service provision are carried out under controlled conditions, and nonconforming products are identified and controlled.
  • Measurement, analysis, and improvement: Ensure that internal audits are conducted, monitoring and measurement of processes and products are established, and analysis of data is performed to demonstrate the suitability and effectiveness of the QMS. Verify that improvement activities are implemented to enhance the quality management system.
  Each section is meticulously designed to guide you through specific checks, helping you identify and mitigate risks effectively. The template also includes space for notes and observations, allowing you to document any issues and track corrective actions. This comprehensive approach ensures that no aspect of supplier quality management is overlooked, providing a robust framework for maintaining a safe working environment in compliance with ISO 13485 regulations.  

Get started with Lumiform’s ISO 13485 supplier audit checklist template

  Ready to enhance safety in your supplier management process? Download Lumiform’s free ISO 13485 supplier audit checklist template today and start conducting thorough and effective inspections. Our user-friendly template will help you ensure compliance, protect your employees, and maintain a safe and efficient supplier management environment. Don’t wait—take the first step towards a safer workplace now! Download your free checklist and transform your supplier quality standards with Lumiform.
Please note that this checklist template is a hypothetical appuses-hero example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.

Other Templates:

This site is registered on wpml.org as a development site. Switch to a production site key to remove this banner.