Purchasing Procedure Template - ISO 13485

Streamline your supplier management and purchasing process with our ISO 13485:2016 Clause 7.4 Purchasing Procedure Template. Ensuring that purchased materials, components, and services meet regulatory and quality requirements is critical for medical device manufacturers. This structured procedure template provides a clear framework for evaluating, selecting, and monitoring suppliers while ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Purchasing Procedure – Covers key ISO 13485:2016 Clause 7.4 requirements.

✔ Supplier Evaluation & Approval Process – Establish criteria for supplier selection and qualification.

✔ Purchase Order & Specification Management – Ensure purchased materials meet design and quality requirements.

✔ Incoming Goods Inspection & Acceptance Criteria – Define verification methods for received materials.

✔ Risk-Based Supplier Monitoring & Performance Tracking – Align with ISO 14971 risk management principles.

✔ Non-Conformance & Corrective Action Handling – Manage supplier issues and deviations effectively.

✔ Audit-Ready Documentation & Record-Keeping – Maintain structured supplier and purchasing records for regulatory compliance.

✔ Editable Digital Format – Fully customizable for various supply chain models and manufacturing needs.

This ready-to-use procedure template is ideal for procurement teams, quality managers, and regulatory professionals, ensuring a structured, compliant, and efficient purchasing process.

Download the ISO 13485:2016 Purchasing Procedure Template today and enhance your supplier management and regulatory compliance!