Quality System Assessment and Records-FY07
- Ensure manufacturer compliance with quality system plans.
- 42 CFR 84.40-43, Subpart E - Quality Control
- All Approval Holders
- 3 Private sector auditing firms
- Respirator manufacturers
- Respirator users
- 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
Content Source: National Institute for Occupational Safety and Health (NIOSH)