SOLICITATION NOTICE
H -- 45 CFR 84, Respiratory Protective Devices; On-Site Compliance Audit Assistance
- Notice Date
- 1/23/2004
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Acquisition and Assistance Field Branch (Pittsburgh), Post Office Box 18070 Cochrans Mill Road, Pittsburgh, PA, 15236-0070
- ZIP Code
- 15236-0070
- Solicitation Number
- 2004-N-01172
- Response Due
- 3/22/2004
- Archive Date
- 4/22/2004
- Point of Contact
- David Staudt, Contract Specialist, Phone 412-386-6459, Fax 412-386-6429, - David Staudt, Contract Specialist, Phone 412-386-6459, Fax 412-386-6429,
- E-Mail Address
-
aku1@cdc.gov, aku1@cdc.gov
- Description
- The Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH) intends to issue a solicitation for performing on-site compliance audit services of respirator manufacturers. The NIOSH National Personal Protective Technology Laboratory (NPPTL), Respirator Branch, is mandated by the United States Congress to certify respiratory devices. Currently, the Respirator Branch has certified over 7,200 approvals and has 62 approval holders' worldwide (covering 16 countries). The regulations which are used to certify these respiratory devices are 42 CFR 84, which include quality assurance and respirator performance requirements. NIOSH conducts on-site compliance audits to verify continued compliance with the regulations after the approval has been granted. The objective of the services provided under this contract is to have contractor audit skills validated and, subsequently, for the contractor to act as a NIOSH authorized representative in preparing, conducting, and closing on-site quality system audits in accordance with 42 CFR 84, ISO 9000, NIOSH Audit Checklist, and Standard Operating Procedure (SOP) for Conducting On-site Compliance Audits. Once training is validated by accompanying a NIOSH representative and participating in several audits, the contractor shall act on the institute's behalf in conducting international on-site compliance audits defined within the FY04 audit schedule. A NIOSH representative may accompany the contractor at any time participating as an audit team member and to monitor the contractor's performance. The contractor's auditors must be accredited by the Registrar Accreditation Board (RAB), or an equivalent national accreditation body for non-US organizations. The contractor's auditors must be knowledgeable of Quality System Standards (i.e., ISO 9000, MIL-STD-1916, etc.) and NIOSH respirator specific quality and performance requirements. The contractor must be able to demonstrate adequate mastery of English and the primary language used by those who are employed at the audit site. It is anticipated that 15 sites will be audited prior to October 30, 2004. Approximately half of the sites are compliant with ISO 9001:1994 or :2000. The other sites have company specific quality systems approved by NIOSH to the requirements of 42 CFR 84. Each site audit must evaluate the manufacturer's complete quality system to a level of assurance provide by current NIOSH staff and practices. Current NIOSH practice is that a site audit can be accomplished by 1 auditor in one full work day. Additional resources may be assigned for sites with language, security or unusual quality system issues. Planned audits include trips to Denmark, England/UK, Germany, Canada, Australia/New Zealand, Japan, and China. All approval holder documentation and audit results are confidential. A confidential statement provided by NIOSH must be signed by all contractor employees who have access to approval holder information prior to preparing and conducting any audits. NIOSH will provide the respirator specific requirements and approval documentation needed to conduct the on-site compliance audits. Solicitation 2004-N-01172 will be available on or about February 9, 2004, and proposals due by March 22, 2004. Written requests for the solicitation documents may be sent to the above address, faxed to (412) 386-6429, or sent via e-mail to aku1@cdc.gov. No telephone requests will be accepted. Solicitation documents will also be available at www.eps.gov.
- Record
- SN00508876-W 20040125/040123211843 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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