Controlled Environment Cleaning Procedure | ISO 13485 | FDA QMSR
Set documented cleaning schedules and methods for a medical device controlled manufacturing environment with this editable procedure. It covers cleaning agents, work surfaces, floors, disinfection and cleaning records.
Building a set? Buy procedures from the same family together and save: 5–9 for 20% off, 10–19 for 35%, 20–39 for 50%, or 40+ for 60%. The discount is applied automatically in your cart, or use Build Your QMS to choose and price a set.
Supplied as one editable Microsoft Word document in a digital download.
Cleaning schedules, methods and records
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.
Selection of cleaning agents and methods
Disinfection of work surfaces, floors and other areas
Cleaning schedules and documented records
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.
Pair cleaning records with the Environmental Controls Procedure for routine monitoring. Both, along with the Cleanroom Design and Validation Procedure, are included in the Cleanroom Procedure Bundle. For personnel entry practices, see the separately sold Controlled Environment Gowning Procedure.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Cleanrooms: Qualification, Monitoring, Cleaning and Gowning for workflow guidance, a checklist and common mistakes.
Part of a procedure bundle
This document is also included in Cleanroom Procedure Bundle. Explore the bundle for the related documents.
