Environmental Controls Procedure

The Environmental Controls Procedure establishes cleanroom controls and monitoring requirements for cleanroom or controlled manufacturing environment use and attributes that affect cleanroom performance.

• ISO 14644-2:2015 aligned

• ISO 13485:2016 aligned

• FDA QMSR aligned

• MS Word Format

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The Environmental Controls Procedure establishes the requirements for cleanroom and controlled manufacturing environments per ISO 14644-1:2015 and ISO 14644-2:2015.

ISO 13485:2016 Environmental Controls Procedure Overview

The Environmental Controls Procedure provides establishes the requirements for cleanrooms and controlled manufacturing environments where a cleanliness standard is intended to be met or where other requirements for the manufacture of medical devices are necessary.

ISO 13485:2016 Environmental Controls Procedure Compliance

The Environmental Controls Procedure is ISO 14644-1:2015, ISO 14644-2:2015, FDA QMSR and ISO 13485:2016 aligned.

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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.