Requirements for the Cleanliness of Product Procedure - ISO 13485

Maintain strict cleanliness standards in medical device manufacturing with our ISO 13485:2016 Clause 7.5 Requirements for Cleanliness of Product Procedure Template. Ensuring that products are clean and contamination-free is critical for patient safety, product effectiveness, and regulatory compliance. This structured procedure template provides a systematic approach to managing and verifying product cleanliness throughout manufacturing, packaging, and distribution, ensuring compliance with ISO 13485:2016, MDR, IVDR, FDA 21 CFR Part 820, and ISO 14971.

✔ Pre-Formatted Cleanliness of Product Procedure – Covers key ISO 13485:2016 Clause 7.5 requirements.

✔ Cleanliness Standards & Acceptance Criteria – Define acceptable cleanliness levels based on product use.

✔ Manufacturing & Handling Controls – Establish contamination prevention measures.

✔ Cleaning & Decontamination Methods – Outline approved cleaning processes for components and final products.

✔ Verification & Monitoring Procedures – Ensure cleanliness is consistently met through testing and inspection.

✔ Risk-Based Approach & ISO 14971 Integration – Identify contamination risks and mitigation strategies.

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

✔ Editable Digital Format – Fully customizable for different medical device classifications and cleanliness requirements.

This ready-to-use cleanliness procedure template is ideal for quality managers, production teams, and regulatory professionals, ensuring a structured, compliant, and effective approach to product cleanliness.

Download the ISO 13485:2016 Cleanliness of Product Procedure Template today and enhance your product safety and regulatory compliance!