ISO 13485 (Clause 7.4) - Supplier On-boarding, Evaluation and Monitoring Spreadsheet
ISO 13485 (Clause 7.4) - Supplier On-boarding, Evaluation and Monitoring Spreadsheet
Template Overview
Template Overview
Streamline your supplier onboarding, evaluation, and monitoring processes with our ISO 13485:2016 Clause 7.4 Supplier Onboarding, Evaluation, and Monitoring Spreadsheet Template. Supplier management is a critical component of the Quality Management System (QMS) for medical device manufacturers, ensuring that suppliers meet both regulatory requirements and your organization’s quality standards. This ready-to-use template helps you systematically assess and monitor supplier performance throughout the lifecycle of your relationship, ensuring ongoing compliance with ISO 13485:2016.
Key Features
Key Features
✔ Pre-Formatted Supplier Evaluation Spreadsheet – Fully aligned with ISO 13485:2016 Clause 7.4 for managing supplier performance.
✔ Supplier Onboarding Checklist – Guide new suppliers through the onboarding process, including qualification and document verification.
✔ Evaluation Criteria – Track quality assessments, audits, and compliance reviews for each supplier.
✔ Ongoing Supplier Monitoring – Monitor supplier performance over time, including delivery timeliness, product quality, and service levels.
✔ Risk Assessment & Mitigation – Document risks associated with suppliers and their mitigation strategies.
✔ Audit-Ready Records – Maintain comprehensive documentation for internal audits and regulatory inspections.
✔ Editable Digital Format – Customizable for various supplier types, products, and business needs.
Why choose a QMS Template?
Why choose a QMS Template?
This Supplier Onboarding, Evaluation, and Monitoring Spreadsheet Template is ideal for quality managers, procurement teams, and compliance officers, ensuring a systematic and compliant approach to managing suppliers.
Download the ISO 13485:2016 Supplier Onboarding, Evaluation, and Monitoring Spreadsheet Template today to optimize your supplier management and compliance processes!
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Additional information
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About Patient Guard
QMSRegs was founded in 2020 by the Patient Guard group to help companies get their medical devices to market and achieve Medical Device compliance. Patient Guard’s consultancy services offers a cost-effective solution for all your Quality Management System needs.
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