Cleanroom Design and Validation Procedure
The Cleanroom Design and Validation Procedure governs the design, build and validation of cleanrooms to ensure compliance with User Requirement Specification (URS), DQ, IQ, OQ, PQ, and certification activities, per applicable standards and regulations, and to ensure the facility is fit for its intended purpose.
ISO 14644 aligned
ISO 13485:2016 aligned
FDA QMSR aligned
MS Word Format
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The Cleanroom Design and Validation Procedure governs the design, build and validation of cleanrooms in accordance with ISO 14644-1:2015, ISO 14644-2:2015, and ISO 14644-4:2022 and other applicable standards and regulations.
Cleanroom Design and Validation Procedure - Overview
The cleanroom design and validation procedure governs cleanroom installations from concept through certification. The procedure provides instruction on the development of a User Requirement Specification (URS) that is the foundation to any cleanroom installation project. The cleanroom design and validation procedure includes instruction on the entire qualification process including required content for:
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Cleanroom Design and Validation Procedure - Compliance
The cleanroom design and validation procedure supports implementation of ISO 14644-1:2015, ISO 14644-2:2015, and ISO 14644-4:2022, ISO 13485:2016 and FDA QMSR. For more information about our Cleanroom Design and Validation Procedure contact us at [email protected]
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.
