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)