Custom NIOSH-compliant Product Quality Plans and Manuals

We can customize a Product Quality Plan and Quality Assurance Manual for NIOSH Approval of your N95 Filtering Facepiece Respirators or other respiratory protective device.

Custom documents will comply with NIOSH-specific 42 C.F.R. Part 84 Quality Plan requirements and those included in the Standard Application Procedure for the Approval of Air-Purifying Filtering Facepiece Respirators Under 42 CFR Part 84

Custom Services Include:

We interview you to learn about your company processes for material receiving, assembly, and inspection and testing. Then we prepare a custom set of documents that includes:

  • Quality Assurance Manual
  • Product Quality Plan
  • Standard Operating Procedures
  • Inspection Test Procedures
  • Product Quality Plan (PQP) Flowchart
  • Assembly Matrix 

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The following requirements derived from 42 C.F.R. Part 84 are completely addressed:

  • Design and Development 42 C.F.R. § 84.41 (a)(2), (b)-(i); 42 C.F.R § 84.61(a)
  • Control of Documents and Data 42 C.F.R 84.41 (a)(2)
  • Control of Purchasing 42 C.F.R 84.41 (a)(4)
  • Product Identification and Traceability 42 C.F.R 84.33 (b), (e)-(g); 42 C.F.R 84.41 (a)(5)
  • Control of Production Processes 42 C.F.R 84.41 (a)(5), (7); 42 C.F.R 84.42 (c)
  • Inspection and Test 42 C.F.R 84.41 (a)(4)-(6)
  • Control of Equipment 42 C.F.R 84.41 (a)(3)
  • Inspection and Test Status and the Control of Nonconforming Product 42 C.F.R 84.41 (a)(4), (5)
  • Corrective Actions 42 C.F.R 84.41 (a)(7)
  • Inventory and Handling Controls 42 C.F.R 84.41 (a)(5)
  • Quality Records 42 C.F.R 84.43 (a)
  • Internal Audits 42 C.F.R 84.41 (a)(7)
  • Training 42 C.F.R 84.41 (a)(7)
  • Quality Management 42 C.F.R 84.40; 42 C.F.R 84.41 (a)(7); 42 C.F.R 84.42
  • Organizational Structure 42 C.F.R 84.41 (a)(7)

What you will do

  • Answer our questions
  • Provide us with the Mask Drawings
  • Provide examples of your forms if applicable
  • Handle the items required for your application that we do not provide such as:
    • Acquiring Pre-test Data
    • Label design
    • Product Instruction Sheet
    • Upload your files with the proper file names

Learn More

Download an NIOSH-compliant Sample — Don't want to download a sample, contact us at 410-451-8006 and we'll tell you everything you want to know.