Supplier Evaluation and Monitoring spreadsheet - ISO 13485

ISO 13485:2016 QMS Template - Supplier Approval, On-boarding, Evaluation, and Monitoring Spreadsheet (QMS.7.4.1.1 - LQR)

Enhance your Quality Management System with our ISO 13485:2016 compliant Supplier Approval, On-boarding, Evaluation, and Monitoring Spreadsheet, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

• Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards. Easy
• Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
• Compliance Assurance: Utilizing our template helps you maintain an effective Supplier Approval, On-boarding, Evaluation, and Monitoring process, demonstrating robust quality management as required by ISO 13485:2016.

Why Do I Need to Keep an Approved Suppliers List?

The ISO 13485 standard requires that organizations seeking certification establish criteria for the evaluation and selection of suppliers. Evaluating, on-boarding, and continually monitoring suppliers leads to the selection of higher quality suppliers and the elimination of unnecessary costs. Maintaining an approved suppliers list provides a reference for employees, preventing purchasing from unevaluated sources and avoiding unnecessary expenditure.

How Should I Evaluate and On-board Suppliers?

Evaluation of suppliers should be:

• Based on the supplier’s ability to provide products that meet your organization’s requirements.
• Based on the performance of the supplier.
• Based on the effect of the purchased product on the quality of the medical device.

Your organization should plan to monitor and re-evaluate suppliers regularly. On-boarding suppliers should be determined as per the supplier category. This template will help you set supplier categories and determine on-boarding requirements for those categories.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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