Customer Related Processes Procedure - ISO 13485

Effectively manage customer-related processes with our ISO 13485:2016 Clause 7.2 Customer-Related Processes Procedure Template. Ensuring that customer needs and regulatory requirements are properly addressed is essential for maintaining product quality, compliance, and customer satisfaction in medical device manufacturing. This structured procedure template provides a systematic approach for handling customer requirements, feedback, and communication, ensuring compliance with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820.

✔ Pre-Formatted Customer-Related Processes Procedure – Covers key ISO 13485:2016 Clause 7.2 requirements.

✔ Customer Requirement Identification & Verification – Define how customer expectations are assessed and documented.

✔ Regulatory & Contractual Compliance – Ensure customer orders comply with applicable laws and industry standards.

✔ Order Processing & Review Procedures – Establish a structured workflow for order acceptance and validation.

✔ Customer Communication & Complaint Handling – Ensure timely and transparent interaction with customers.

✔ Risk-Based Approach & CAPA Integration – Identify customer-related risks and implement corrective actions.

✔ Audit-Ready Documentation & Record Keeping – Maintain structured customer records for regulatory inspections.

✔ Editable Digital Format – Fully customizable for different medical device businesses and customer management needs.

This ready-to-use customer-related processes procedure is ideal for sales teams, quality managers, and regulatory professionals, ensuring a structured, compliant, and customer-focused approach.

Download the ISO 13485:2016 Customer-Related Processes Procedure Template today and enhance your customer satisfaction and compliance strategy!