Know Before You Apply: Summarized Quality Requirements Needed to Achieve NIOSH Approval
DHHS (NIOSH) Publication Number 2023-132
The National Institute for Occupational Safety and Health (NIOSH) Respirator Approval Program frequently receives questions from manufacturers, distributors, and designers related to NIOSH respirator approval applications. Frequently, NIOSH is not able to approve an application because achieving NIOSH approval requires implementing a robust quality management system in addition to meeting performance requirements. This booklet provides an overview of the NIOSH approval process and the application package requirements to address the most frequently asked questions, deter inappropriate applications, and better prepare potential NIOSH approval holders for the application process.