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NIOSH Conformity Assessment Notice, CA 2021-1034R1 - Summarized Information about NIOSH Respirator Approval Program (i) Basic Application Procedures (ii) Quality Assurance Requirements and (iii) Supplier or Subcontractor Agreements. Supersedes: March 2021 version. Supersedes: April 7, 2005 Letter to All Manufacturers, Clarification of Supplier and Subcontractor Relationships. Supersedes: September 24, 2012 Letter to All Manufacturers, Respirator Sampling Procedures.
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06/09/2021
[PDF-386.24 KB]
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Description:NIOSH requires approval holders to meet performance requirements and the respirators must be manufactured under a quality management system (QMS) that is reviewed and accepted as part of the approval process. To keep NIOSH’s applicants informed about the respirator approval program, NIOSH is providing this document to clarify expectations related to (1) the basic application procedures; (2) the quality assurance (QA) requirements in the NIOSH regulation, 42 CFR Part 84, Subpart E; and (3) requirements for supplier and subcontractor agreements.
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