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Quality System Assessment and Records-FY08


  • Ensure manufacturer compliance with quality system plans.
Manufacturer to Customer

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
  • Initiate laboratory audits
  • Begin ISO 17025 planning


  • Issue Domestic audit Task Orders (on-going)
  • Issue International audit Task Orders (on-going)
  • Finalize & Implement Product Audit Selection Logic
  • Determine requirements for external lab qualification


  • At least 45 site audits performed in FY08
  • At least 50 product audits performed in FY08


  • Approval Holder quality systems and products continue to meet standard
  • Approval Holders assure quality and reliability of respirators
  • Workers have stronger assurance of respiratory functionality
Page last updated: August 08, 2008
Page last reviewed: August 08, 2008
Content Source: National Institute for Occupational Safety and Health (NIOSH)