Controlled Environment Cleaning Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Controlled Environment Cleaning Procedure provides instruction on the cleaning practices utilized in medical device manufacturing environments.

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Controlled Environment Cleaning Procedure

The Controlled Environment Cleaning Procedure provides instruction on the cleaning practices utilized in cleanrooms or controlled manufacturing environments.

Controlled Environment Cleaning Procedure Overview

The Controlled Environment Cleaning Procedure establishes routine cleanroom cleaning requirements for daily, weekly, monthly and yearly cleaning and controlled environment care. The Controlled Environment Cleaning Procedure includes instruction for cleaning cleanroom work surfaces, including work surface disinfection, floor cleaning, including yearly refinish and seal requirements, and other surface cleaning requirements.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.