Common Site Audit Nonconformance: Lack of Internal Audit Procedures and Documentation

NIOSH conducts various respirator post-market conformity evaluations, including site audits, to ensure respirators continue to be manufactured to an approval holder’s accepted quality control plan (QCP) and quality management system (QMS). During site audits, NIOSH identifies and informs approval holders of any nonconformances with their QCP or other aspects of their QMS. NIOSH has found many instances where approval holders do not meet internal audit requirements in accordance with their QMS and the requirements in 42 Code of Federal Regulations Part 84. This PPE Case Notes details nonconformances identified during site audits and best practices approval holders
should follow for internal audits.

Common Site Audit Nonconformance: Lack of Internal Audit Procedures and Documentation

Suggested Citation

NIOSH [2024]. Common Site Audit Nonconformance: Lack of Internal Audit Procedures and Documentation. By Nichols, A, Greenawald LA, Wiltanger, P. Pittsburgh, PA. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, https://www.cdc.gov/niosh/npptl/ppecase/pdfs/PPE-CASE-Notes-Internal-Audit.pdf.

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