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Quality System Assessment and Records-FY07

NOTE: This page is archived for historical purposes and is no longer being maintained or updated.
Current Information can be found at: Quality System Assessment and Records - FY08


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

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 by 12/30/2005
  • Issue International audit Task Orders by 6/30/2006
  • Finalize & Implement Product Audit Selection Logic
  • Determine requirements for external lab qualification.
  • Begin ISO 17025 activities by 4/1/2006.


  • At least 45 site audits performed in FY07
  • At least 50 product audits performed in FY07


  • 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 modified: July 23, 2007
Page last reviewed: July 23, 2007 (archived document)
Content Source: National Institute for Occupational Safety and Health (NIOSH)