Environmental Controls Procedure | ISO 13485 | FDA QSR Compliant
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 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Environmental Controls ProcedureThe Environmental Controls Procedure establishes the requirements for cleanroom and controlled manufacturing environments per ISO 14644-1:2015 and ISO 14644-2:2015.
ISO 13485 Environmental Controls Procedure OverviewThe 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 Environmental Controls Procedure ComplianceThe Environmental Controls Procedure is ISO 14644-1:2015, ISO 14644-2:2015, FDA QSR and ISO 13485:2016 compliant.
To learn more about our ISO 13485 Environmental Controls Procedure contact us at [email protected]
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