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
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.