Know Before You Apply:

Summarized Quality 

Requirements 

Needed to Achieve 

NIOSH Approval 

Centers for Disease Control

and Prevention

National Institute for Occupational 

Safety and Health
ii

This document is in the public domain and may be freely copied or reprinted

Disclaimer

Mention of any company or product does not constitute endorsement by the National Institute 

for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention.

The Know Before You Apply: Summarized Quality Requirements Needed to Achieve NIOSH 

Approval booklet provides a general overview of the NIOSH approval process. This booklet is 

for guidance purposes only. All manufacturers must meet the regulatory requirements stated 

in 42 Code of Federal Regulations Part 84 to become NIOSH approval holders.

Get More Information

Find NIOSH products and get answers to workplace safety and health questions:

1-800-CDC-INFO (1-800-232-4636) | TTY: 1-888-232-6348

CDC/NIOSH INFO: cdc.gov/info | cdc.gov/niosh

Monthly NIOSH eNews: cdc.gov/niosh/eNews

Suggested Citation

NIOSH [2023]. Know before you apply: summarized quality requirements needed to achieve 

NIOSH approval. By Sewchok H, Miller C. Pittsburgh, PA: U.S. Department of Health 

and Human Services, Centers for Disease Control and Prevention, National Institute for 

Occupational Safety and Health, DHHS (NIOSH) Publication No. 2023-132.

DHHS (NIOSH) Publication No. 2023-132

DOI: https://doi.org/10.26616/NIOSHPUB2023132

July 2023
iii

Contents

1 What Makes the NIOSH Approval Different?

2 Terms and Definitions to Understand Before You Apply

4 The NIOSH Approval Process at a Glance

5 The NIOSH Approval Process for First-Time Applicants at a Glance

6 Before You Apply

7 In-progress Applications for First-Time Applicants

8 Quality Assurance Requirements

10 Quality Assurance Review Requirements

12 Familiarize Yourself with These Resources Before You Apply

13 Are You Ready to Apply?
1

What Makes the NIOSH 

Approval Different?

The National Institute for Occupational Safety and Health (NIOSH) is the federal agency 

responsible for testing and approving respirators used in U.S. workplace settings. The 

National Personal Protective Technology Laboratory (NPPTL) is the division within 

NIOSH responsible for executing all functions of the NIOSH Respirator Approval 

Program. NIOSH only approves respirators that pass its strict quality assurance and 

performance requirements as identified in regulation 42 Code of Federal Regulations 

Part 84 (42 CFR Part 84).

The NIOSH approval is more than just passing a one-time test or a recognition that a 

product meets a standard at the time of application. Achieving NIOSH approval requires 

active quality assurance that is further described in this booklet. A NIOSH approval 

holder must continue to meet the conditions of the approval as granted. The result is 

confidence that when a respirator is approved by NIOSH, it can protect the user. This 

confidence is critical to the millions of workers who rely on respirators to protect them 

from exposures to respiratory hazards in workplace settings. 
2

Terms and Definitions to Understand Before You Apply

Respirator

A device designed to provide the wearer with 

respiratory protection against inhalation of 

hazardous contaminants from the surrounding 

atmosphere. NIOSH approves respirators for 

use in occupational settings.

Manufacturer

Applicants and approval holders may be 

referred to as “manufacturers” throughout this 

booklet.

Manufacturer Code

NIOSH issues a three-digit code specific to each 

applicant—known as a manufacturer code—

to track applications for each manufacturer. 

NIOSH issues only one three-digit code to each 

applicant. Once you receive a code, you never 

need to apply for another. However, you must 

have this assigned manufacturer code before 

you begin the respirator approval application 

process. This code will only be used for 

tracking purposes and does not imply NIOSH 

approval or that NIOSH approval is pending.

A manufacturer code will only be issued to 

the company that controls the design and 

manufacturing of the respirators put forward 

for approval. If there are any changes to the 

information provided to achieve the code, 

NIOSH must be informed by email to the NIOSH 

NPPTL Records Room.

Standard Application Form (SAF)

Once you obtain a manufacturer code, NIOSH 

will send you the Standard Application Form 

to submit a single approval request for a new 

respirator. All required documentation must be 

provided including the quality control plan, test 

samples, and appropriate fees, as detailed in 

the six Standard Application Procedures that 

NIOSH provides (see additional resources on 

page 12).
3

Terms and Definitions to Understand Before You Apply

Quality Management System (QMS)

This overall system should include product 

quality control plans (PQPs), a quality manual 

or manuals, standard operating procedures, 

and any other quality documentation. This 

system must be complete to ensure product 

quality and meet the specific requirements in 

42 CFR Part 84.

Product Quality Control Plan (PQP)

The documentation required as part of 

an application to demonstrate the quality 

inspections for a specific respirator or 

respirator component.

Inspection Procedures

The U.S. Code of Federal Regulations 42 CFR 

Part 84 requires that all approval holders 

provide detailed explanations of how they will 

carry out inspection procedures within their 

manufacturing sites. Your company must 

also define its processes to (1) ensure that 

only acceptable materials or components 

are used within the production process, (2) 

discard nonconforming material or products 

(i.e., return materials to the vendor), and (3) 

evaluate the impact of nonconforming material 

on any in-process or distributed product. All 

procedural records must be maintained for the 

life of the product.

Respirator Samples

Full-production or limited-production respirators/

respirator parts made and released using the 

defined quality management system, including 

inspection records.

Sampling Plan

A statistical method to determine how many 

samples should be be evaluated and tested for 

a given lot, along with the number of allowable 

defects considered acceptable for the lot. 

Methods that are typically accepted by NIOSH 

are published standard procedures such as 

MIL-STD-105D.
4

The NIOSH Approval Process at a Glance

As a manufacturer seeking NIOSH approval, you must take several steps 

before submitting your product for NIOSH approval as described in this 

booklet. These steps include answering a defined set of questions provided 

by NIOSH to assess your readiness to apply for NIOSH approval, obtaining 

a NIOSH manufacturer code, and ensuring that you understand and 

have completely prepared all the required documentation in advance. 

NIOSH expects that, prior to submitting your application, you will have 

all the required elements of the production process in place using the 

same quality management system that you are submitting as part of your 

application package.

After NIOSH issues you a manufacturer code, you may then submit all the 

required elements of your application package, including the Standard 

Application Form, application fee payment or proof of payment, 

respirator samples for NIOSH evaluation, and any additional required 

documentation as listed on page 6 within this booklet. If NIOSH 

accepts the submission of your application, NIOSH will assign it a 

task number. NIOSH will then review your application and test your 

product in accordance with Standard Testing Procedures.

While there are many parts of the overall NIOSH review process, the 

quality assurance review may present the biggest challenge for new 

applicants. NIOSH will evaluate your quality management system 

(QMS) to ensure you have the processes in place to maintain the 

quality of your respirators. This review will include a site visit, referred to 

as a site qualification, to any location in which manufacturing and QMS 

activities are specified. As part of the site qualification, NIOSH will verify 

that specific quality documents, such as inspection procedures, including 

classification of defects (see 42 CFR Part 84 Subpart E), the sampling 

plan, and sampling levels have been fully and correctly used.

NIOSH approval is not guaranteed. Any respirators produced prior to receiving your 

NIOSH approval should not be assumed to be acceptable. Therefore, production 

quantities should be carefully considered until the approval is finalized.

NOTE
5

The NIOSH Approval Process for 

First-Time Applicants at a Glance

Submit a complete application

1. Establish a QMS

2. Implement the QMS

3. Complete production run

using the QMS

4. Obtain a manufacturer code

5. Prepare your application

package

NIOSH performs testing

Not acceptable

(denied)

Provisionally Acceptable:

Submit responses to

Corrective Action Request (CAR)

issued to you by NIOSH

Site

qualification

assessment

NIOSH reviews quality 

management system

Approval

NIOSH 

reviews

CAR

Acceptable for

Final Review

CAR

accepted

NIOSH initial review of application package Before you apply:

NOTES

It is important to read the regulation 

and the resources referenced in this 

booklet prior to applying. An application 

can be denied at any point in this 

process if it is determined to not meet 

the requirements.
6

Before You Apply

Manufacturer Code

Contact the NIOSH NPPTL Records Room 

at RecordsRoom@cdc.gov to request a 

manufacturer code. The first step in this process 

will require you to supply answers to a set 

of defined questions. This will help you, and 

NIOSH, to assess if the NIOSH approval process 

is right for your product and your company. If 

your answers demonstrate you are ready to 

apply for NIOSH approval, NIOSH will follow 

up with you and seek additional information. If 

NIOSH determines you are not ready, you will be 

informed by email.

NIOSH asks all manufacturers to provide photos 

of the production line and quality assurance area 

as well as photos of the facility with a visible logo 

or company name on the building. Manufacturers 

should not send digitally altered images. NIOSH 

will assign a three-letter manufacturer code 

after the information provided is reviewed and 

accepted by NIOSH. A manufacturer must have 

an assigned manufacturer code before beginning 

the respirator approval application process. 

Manufacturers should use this identification 

code for every approval application, regardless if 

they complete the process for one respirator or 

many. 

Elements Required in Your Application Package 

Manufacturers must submit the following according to the Standard Application Procedure with their 

application:

 Standard Application Form

 Assembly matrix

 Draft approval label

 Drawing(s)

 Any overarching QMS documents (see page 8)

 Pre-submission test data

 Additional information required by the type of 

respirator submitted for approval

 Product Quality Control Plan

 Inspection procedures

 Sampling plans

 Classification of defects

 User instructions

 Respirator samples

 $200 fee

These documents and respirator samples should all be submitted within a two-week time period 

and include the $200 (U.S. dollar) application fee.
7

In-progress Applications for First-Time Applicants

Once you receive your manufacturer code, the 

next step is to fill out the Standard Application 

Form and submit your package, which should 

include all the information on the checklist on 

page 6 within this booklet. NIOSH will assign a 

task number (TN) specific to your application 

package and inform the primary contact by 

email. The application package will go through 

respirator sample testing and review including a 

quality assurance review (see pages 8 through 

11).

While NIOSH reviews the application, NIOSH 

reviewers may correspond with the applicant’s 

primary contact to clarify or correct identified 

issues as the project moves through the 

review process. NIOSH reviewers will email 

the primary contact and communicate the 

expected timelines for response. If everything 

is determined to be sufficient and meets the 

requirements, a manufacturing site qualification 

visit or visits will be scheduled (for first-time 

applicants only).

At any time during the review process, NIOSH 

can deny the application and will formally inform 

the manufacturer.

Site Qualification Visit 

NIOSH will visit a first-time applicant’s facility, or 

facilities, to determine if the quality management 

system presented, including the production 

process, inspection, etc., are consistent with 

the supplied documentation and meet NIOSH 

requirements. NIOSH will verify that records are 

available and show that the QMS was followed as 

described in the application when manufacturing 

the samples sent to NIOSH. The findings from 

this assessment will be scored and will fall into 

one of three categories: (1) acceptable, (2) 

provisionally acceptable, or (3) not acceptable. 

A NIOSH approval will ONLY be granted if the 

site qualification is acceptable.

If the site qualification is determined to be 

provisionally acceptable, corrective actions will 

be required before the site qualification will 

be considered acceptable and an approval is 

issued. If the site qualification is not acceptable, 

the project will be denied. NIOSH will provide 

site qualification letters to summarize the 

findings and separate approval or denial letters.

To stay informed of all NIOSH announcements and application process requirements, applicants are 

encouraged to frequently check the NIOSH NPPTL conformity assessment notice webpage. Approval 

holders will automatically be added to the NIOSH NPPTL manufacturer listserv to receive notice when 

there are new conformity assessment notices. Private label assignees should sign up for the NIOSH 

NPPTL general listserv in order to receive important NIOSH respirator approval program updates.

NOTE
8

Labeling 42 CFR 84.33 (d)

The manufacturer must ensure that only NIOSH 

Approved® configurations are labeled as NIOSH 

approved.

Design and Development 42 CFR 

84.41 (a)(2), (b)–(i); 42 CFR 84.61(a)

The manufacturer must address design inputs 

(physical and performance characteristics), 

design outputs (drawings, classification of 

defects, and incoming, in-process, and final 

inspections), and appropriate reviews and 

approvals of the design and development 

process, including both verification and 

validation.

Control of Documents and Data 

42 CFR 84.41 (a)(2)

The manufacturer must have a process to 

uniquely identify all documents which constitute 

quality control plans, drawings, procedures, and 

forms, including a date of revision or revision 

level. The manufacturer must ensure there is 

an internal review and approval process for all 

new and revised drawings and documents and 

have a procedure in place for the distribution 

of all controlled documents within the quality 

system, including a process for the removal of 

any obsolete documents to prevent unintentional 

use. The manufacturer must ensure that all data 

collection is controlled to prevent unintentional 

alterations.

Quality Assurance Requirements

Control of Purchasing 

42 CFR 84.41 (a)(4)

The manufacturer must have a process in place 

that can achieve the following:

1. Identify qualified suppliers and be able to 

evaluate both the initial quality of suppliers 

and the sustained quality through periodic 

evaluations,

2. Communicate material and/or component 

requirements to suppliers, and

3. Receive and review all incoming materials or 

components.

Product Identification and Traceability 

42 CFR 84.33 (b), (e)–(g); 

42 CFR 84.41 (a)(5)

The manufacturer must be able to achieve the 

following:

1. Implement a procedure to identify raw 

materials used within the production 

process;

2. Properly label all respirators and respirator 

components;

3. Track, or trace, the essential components of 

the respirator; and

4. Implement a procedure to properly identify 

the finished respirator and required major 

subassemblies.
9

Control of Production Processes 42 

CFR 84.41 (a)(5), (7); 42 CFR 84.42 (c)

The manufacturer must have adequate

documentation to ensure that the manufacturing 

process is consistently performed and followed, 

including any procedure for the setup of assembly 

or testing devices, assembly processes, and 

inspection procedures.

Control of Equipment 

42 CFR 84.41 (a)(3)

The manufacturer must have a process to select 

appropriate measuring and test equipment and 

maintain a calibration schedule. The manufacturer 

will be required to review the calibration records 

and identify the testing equipment’s calibration 

status. As part of this process, the manufacturer 

must maintain all calibration records and evaluate 

the impact of out-of-tolerance equipment against 

any in-process or distributed product.

Corrective Actions 42 CFR 84.41 (a)(7)

When the manufacturer identifies an issue with a 

respirator or its production, through a legitimate 

source, such as an internal or external audit, the 

manufacturer must be able to correct the part of 

the system that is not conforming to the approved 

production procedure, thereby causing the issue. 

The manufacturer must also be able to mitigate the 

negative outcomes of this nonconformity.

Inventory and Handling Controls 

42 CFR 84.41 (a)(5)

The manufacturer must identify a process to 

prevent the damage of all raw materials, in-process 

components, and finished NIOSH products.

Quality Records 42 CFR 84.43 (a)

Records of all the requirements listed here and 

otherwise noted in the NIOSH approval application 

process must be retained and accessible.

Internal Audits 42 CFR 84.41 (a)(7)

The manufacturer must establish a schedule for 

internal audits and maintain those audit records.

As part of this, the manufacturer must establish a 

procedure to determine how internal auditors are 

qualified. The internal audit program must cover 

the entire quality system, including the approved 

product quality control plan.

Training 42 CFR 84.41 (a)(7)

The manufacturer must have a procedure to train 

and monitor personnel, which includes ensuring 

only authorized personnel assemble, test, and 

inspect a NIOSH Approved product. A procedure 

must be in place to ensure applicable personnel are 

notified of production process modifications.

Organizational Structure 

42 CFR 84.41 (a)(7)

The manufacturer must establish an organizational 

structure to identify those positions responsible for 

fulfilling the requirements of the product quality 

control plan.

NOTE

This guidance is provided in this document to help you better prepare for 

the rigorous NIOSH approval process. This is a summary of Conformity 

Assessment Notice: NIOSH quality control plan requirements, NIOSH 

CA 2019-1019 and the guidance is not all-inclusive. For the exact 

requirements of the NIOSH approval process, see the Standard 

Application Procedure for the respirator type you wish to produce. 
10

Quality Assurance Review Requirements

Clearly define incoming inspection 

procedures and verify that the materials 

received conform to the ordered 

specifications. 

Clearly define in-process inspection 

procedures used to verify material or 

design quality, when applicable. 

Clearly define final inspection 

procedures and verify that the fully 

assembled respirator conforms to the 

specifications on the drawing and the 

required performance specifications. 

(Refer to drawing checklist to the right.)

1

2

3

The manufacturer is expected to verify 

the accuracy of all measurements and 

information included on a drawing. 

Incoming, in-process, and final inspections 

must be assigned a classification of defects 

according to the definitions in 42 CFR Part 

84 Subpart E.

Engineering Drawing Checklist for Filtering Facepiece Respirators (FFRs)

Below is an FFR-specific example of a checklist that can be found in the SAP. It shows what 

you must include on the drawing. Manufacturers should prepare this information before 

starting the application process.

• Proper title, signature/initials, number, date, and revision level

• Applicable product quality control plan document number(s)

• Location of the full NIOSH approval label

• Dimensions for facepiece, liner, valve, straps, and nosepiece

• Material specifications, including color, for filter media, valve, nosepiece, straps, and liner

• Dimensional location of nosepiece, liner, straps, and valve

• Part number and its location on the respirator

• Lot number and lot number key

• Location of the lot number (on the respirator or on the packaging) is noted

• Abbreviated approval label

• Filtration efficiency (N95, N99, N100, etc.) including nuisance protections

• Filters containing carbon layers include a statement that carbon is chromium free

• Final filter media form (cup, flat fold, duckbill, etc.)

• Filtering mechanism (electrostatic, mechanical, or other)

• Strap attachment method

• Strap elasticity definition (listed as a percentage or maximum length at a known force)

• Staples or sonic welds, if used to fasten straps, are identified as whether 

or not the attachment points are within the breathing zone

• Private label version and abbreviated label, if applicable

• Expiration date, if applicable

• Documentation of the purple or magenta label color requirement for P100 filters, only

when applicable

NOTE

The checklist on this page is abbreviated and 

specifically for FFRs. See the full version of this 

checklist, and the engineering drawing checklists 

for other respirator types, in the appropriate 

Standard Application Procedure.
11

Product Quality Control Plan

NIOSH must have confidence that approved respirators in use provide 

the expected (same) level of protection as the lot sample that was 

originally tested by NIOSH. Implementation and use of a quality control 

plan using a sampling standard ensures the quality of the product. 

Before you apply, familiarize yourself with how to implement an 

effective sampling standard, such as those in the table below. If you do 

not understand how to effectively use one of these sampling standards 

or an equivalent standard, you are not yet ready to apply for a NIOSH 

respirator approval.

The sampling standard for each inspection must be clearly stated in this 

part of your application. You must clearly define a lot size.

Acceptable Quality Level (AQL)

A classification of defects document must be submitted with 

each application. 42 CFR Part 84.41(c) through 84.41(e) requires 

you to identify each characteristic. The NIOSH classification of 

defects is specific to respirators and their definitions must be 

carefully considered.

Defect Classification Major A Major B Minor

AQL+ 1.0 2.5 4.0

Examples of standards and minimum inspection levels 

acceptable to NIOSH

Minimum Inspection Level

Procedure Normal Destructive1

MIL-STD-414 IV I

ANSI/ASQ Z1.9-2003 II S-3

MIL-STD-105D II S-2

MIL-STD-105E II S-2

ANSI/ASQ Z1.4-2003 II S-2

ISO 28592 II S-2

For more information about how to select and use a sampling procedure, 

see the NIOSH Conformity Assessment Notice (CA 2021-1034R1).

1Destructive inspections are considered those that, once performed, 

render the respirator or respirator component unable to be used.

2Reduced sampling is not permitted with this plan.
12

Familiarize Yourself with These Resources 

Before You Apply

42 CFR Part 84—The Code of Federal Regulations (CFR) are the rules and regulations 

published in the Federal Register by the executive departments and agencies of the federal 

government of the United States. Part 84 addresses NIOSH approval requirements for 

respiratory protective devices.

Standard Application Procedure (SAP)—This document should be used as a companion 

to the Standard Application Form, offering detailed explanations for each part of the 

approval process. A separate version of the document has been created for each class of 

respirator. NIOSH recommends that applicants review the entire document to determine the 

appropriate respirator class before submitting a respirator for approval.

Standard Testing Procedures (STPs)—Explanation of how NIOSH tests the submitted 

respirator against the performance requirements set in 42 CFR Part 84.

Conformity Assessment Notices and Letters to Manufacturers—Documents developed to 

provide information about policy, procedure, or testing changes.

Noteworthy Conformity Assessment Notices and Letters to Manufacturers

• Conformity Assessment Notice, NIOSH Respirator Approval Contents and Meaning, 

NIOSH CAN 2019-1012

• Summarized Information about NIOSH Respirator Approval Program (i) Basic 

Application Procedures, (ii) Quality Assurance Requirements, and (iii) Supplier or 

Subcontractor Agreements, NIOSH CA 2021-1034-R1

• Conformity Assessment Notice: NIOSH quality control plan requirements, 

NIOSH CA 2019-1019

• Conformity Assessment Letter: Interim guidance regarding applications for NIOSH 

Approval of Filtering Facepiece Respirators in accordance with the Food and Drug 

Administration (FDA) Final Order, NIOSH CA 2018-1010R1.0
13

Are You Ready to Apply?

Have you thoroughly reviewed the information 

provided in this booklet as well as the 

information at each of the links on page 12?

Have you designed, developed, and produced 

a respirator using your documented quality 

assurance processes and procedures?

Have you implemented a quality control system 

that includes the requirements in 42 CFR Part 

84 Subpart E and the information provided in 

NIOSH CA 2020-1019?

Has your current/final respirator design been 

evaluated against the NIOSH Standard Testing 

Procedures (STPs) to verify performance of the 

design?

Have you established an inspection and 

sampling procedure based on variables or 

attributes to ensure that critical respirator 

performance requirements are met, per NIOSH 

requirements?

Are you prepared to send photos to NIOSH of 

the production line and quality assurance area 

as well as of the facility with a visible logo or 

company name on the building?

NIOSH expects that the samples tested 

for pre-submission test data and sent to 

NIOSH for evaluation were made using the 

fully executed quality management system 

described to NIOSH. This would include 

everything from design and development 

through all inspections described in the PQP.
Promoting productive workplaces through safety and health research

DHHS (NIOSH) Publication No. 2023-132

DOI: https://doi.org/10.26616/NIOSHPUB2023132