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Quality System Assessment and Records - FY10

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 - FY11

Objective

  • 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

Stakeholders

  • Respirator manufacturers
  • Respirator users

Project Scope


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

Milestones

  • Issue site-audit Task Orders (on-going)
  • Generate new audit support contract FY2010
  • Perform product audits (on-going)

Outputs

  • At least 40 site audits opened in FY09, 68 closed
  • At least 39 product audits performed in FY09

Outcomes

  • 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: April 5, 2010
Page last reviewed: April 5, 2010
Content Source: National Institute for Occupational Safety and Health (NIOSH)
National Personal Protective Technology Laboratory