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Quality System Assessment and Records-FY06

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-FY07

Objective

  • Audit Approval Holder quality systems on-site. Perform product audits of respirators at NPPTL. Audit laboratories supplying test data to NPPTL. Improve internal NPPTL systems and processes.
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
  • Initiate laboratory audits.
  • Begin ISO 17025 planning.

Milestones

  • 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.

Outputs

  • At least 45 site audits performed in FY06
  • At least 50 product audits performed in FY06

Outcomes

  • Approval Holder quality systems and products continue to meet standard.
  • Approval Holders improve quality and reliability of respirators.
  • Workers have stronger assurance of respiratory functionality.
  • NPPTL recognized as providing value through monitoring activities.
Page last modified: July 23, 2007
Page last reviewed: July 23, 2007 (archived document)
Content Source: National Institute for Occupational Safety and Health (NIOSH)