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Quality System Assessment and Records - FY12

NOTE: This page is archived for historical purposes and is no longer being maintained or updated.


  • Ensure manufacturer compliance with quality system plan.
Manufacturer to Customer pipeline clip art

Applicable Standards

  • 42 CFR 84.40-43, Subpart E - Quality Control

Key Partners

  • All Approval Holders
  • 3 Private sector auditing firms


  • Respirator manufacturers
  • Respirator users

Project Scope

  • Perform a site audit every 2 years for all Approval Holders
  • Perform respirator product audits


  • Complete FY2011 interim contracts (one of three closed)
  • Issue FY2012 interim contracts (simplified acquisition)
  • Generate new 5-year audit support contract
    • Issue Task Orders once base contract in place
  • Perform product audits (on-going)


  • Site Audits FY2011: 21 opened, 61 closed
  • Site Audits FY2012: 37 opened, 16 closed (to date)
  • Product Audits FY2011: 132 opened, 140 closed
  • Product Audits FY2012: 76 opened, 58 closed (to date)


  • Approval Holder quality systems and products continue to meet standard or approval revoked.
  • Approval Holders assure quality and reliability of respirators.
  • Workers have stronger assurance of respiratory functionality.
Page last updated: April 17, 2012
Page last reviewed: April 17, 2012
Content Source: National Institute for Occupational Safety and Health (NIOSH)
National Personal Protective Technology Laboratory