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e-CFR data is current as of September 24, 2020

Title 14Chapter ISubchapter CPart 21 → Subpart K


Title 14: Aeronautics and Space
PART 21—CERTIFICATION PROCEDURES FOR PRODUCTS AND ARTICLES


Subpart K—Parts Manufacturer Approvals


Contents
§21.301   Applicability.
§21.303   Application.
§21.305   Organization.
§21.307   Quality system.
§21.308   Quality manual.
§21.309   Location of or change to manufacturing facilities.
§21.310   Inspections and tests.
§21.311   Issuance.
§21.313   Duration.
§21.314   Transferability.
§21.316   Responsibility of holder.
§21.319   Design changes.
§21.320   Changes in quality system.

Source: Docket No. FAA-2006-25877, Amdt. 21-92, 74 FR 53390, Oct. 16, 2009, unless otherwise noted.

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§21.301   Applicability.

This subpart prescribes—

(a) Procedural requirements for issuing PMAs; and

(b) Rules governing holders of PMAs.

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§21.303   Application.

(a) The applicant for a PMA must apply in a form and manner prescribed by the FAA, and include the following:

(1) The identity of the product on which the article is to be installed.

(2) The name and address of the manufacturing facilities at which these articles are to be manufactured.

(3) The design of the article, which consists of—

(i) Drawings and specifications necessary to show the configuration of the article; and

(ii) Information on dimensions, materials, and processes necessary to define the structural strength of the article.

(4) Test reports and computations necessary to show that the design of the article meets the airworthiness requirements of this subchapter. The test reports and computations must be applicable to the product on which the article is to be installed, unless the applicant shows that the design of the article is identical to the design of a article that is covered under a type certificate. If the design of the article was obtained by a licensing agreement, the applicant must provide evidence of that agreement.

(5) An applicant for a PMA based on test reports and computations must provide a statement certifying that the applicant has complied with the airworthiness requirements of this subchapter.

(b) Each applicant for a PMA must make all inspections and tests necessary to determine—

(1) Compliance with the applicable airworthiness requirements;

(2) That materials conform to the specifications in the design;

(3) That the article conforms to its approved design; and

(4) That the manufacturing processes, construction, and assembly conform to those specified in the design.

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§21.305   Organization.

(a) Each applicant for or holder of a PMA must provide the FAA with a document—

(1) Describing how its organization will ensure compliance with the provisions of this subpart;

(2) Describing assigned responsibilities, delegated authorities, and the functional relationship of those responsible for quality to management and other organizational components; and

(3) Identifying an accountable manager.

(b) The accountable manager specified in paragraph (a) of this section must be responsible within the applicant's or production approval holder's organization for, and have authority over, all production operations conducted under this part. The accountable manager must confirm that the procedures described in the quality manual required by §21.308 are in place and that the production approval holder satisfies the requirements of the applicable regulations of subchapter C, Aircraft. The accountable manager must serve as the primary contact with the FAA.

[Doc. No. FAA-2013-0933, Amdt. 21-98, 80 FR 59031, Oct. 1, 2015]

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§21.307   Quality system.

Each applicant for or holder of a PMA must establish a quality system that meets the requirements of §21.137.

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§21.308   Quality manual.

Each applicant for or holder of a PMA must provide a manual describing its quality system to the FAA for approval. The manual must be in the English language and retrievable in a form acceptable to the FAA.

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§21.309   Location of or change to manufacturing facilities.

(a) An applicant may obtain a PMA for manufacturing facilities located outside of the United States if the FAA finds no undue burden in administering the applicable requirements of Title 49 U.S.C. and this subchapter.

(b) The PMA holder must obtain FAA approval before making any changes to the location of any of its manufacturing facilities.

(c) The PMA holder must immediately notify the FAA, in writing, of any change to the manufacturing facilities that may affect the inspection, conformity, or airworthiness of its PMA article.

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§21.310   Inspections and tests.

(a) Each applicant for or holder of a PMA must allow the FAA to inspect its quality system, facilities, technical data, and any manufactured articles and witness any tests, including any inspections or tests at a supplier facility, necessary to determine compliance with this subchapter.

(b) Unless otherwise authorized by the FAA, the applicant or holder—

(1) May not present any article to the FAA for an inspection or test unless compliance with §21.303(b)(2) through (4) has been shown for that article; and

(2) May not make any change to an article between the time that compliance with §21.303(b)(2) through (4) is shown for that article and the time that the article is presented to the FAA for the inspection or test.

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§21.311   Issuance.

The FAA issues a PMA after finding that the applicant complies with the requirements of this subpart and the design complies with the requirements of this chapter applicable to the product on which the article is to be installed.

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§21.313   Duration.

A PMA is effective until surrendered, withdrawn, or the FAA otherwise terminates it.

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§21.314   Transferability.

The holder of a PMA may not transfer the PMA.

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§21.316   Responsibility of holder.

Each holder of a PMA must—

(a) Amend the document required by §21.305 as necessary to reflect changes in the organization and provide these amendments to the FAA;

(b) Maintain the quality system in compliance with the data and procedures approved for the PMA;

(c) Ensure that each PMA article conforms to its approved design and is in a condition for safe operation;

(d) Mark the PMA article for which an approval has been issued. Marking must be in accordance with part 45 of this chapter, including any critical parts;

(e) Identify any portion of the PMA article (e.g., sub-assemblies, component parts, or replacement articles) that leave the manufacturer's facility as FAA approved with the manufacturer's part number and name, trademark, symbol, or other FAA approved manufacturer's identification;

(f) Have access to design data necessary to determine conformity and airworthiness for each article produced under the PMA;

(g) Retain each document granting PMA and make it available to the FAA upon request; and

(h) Make available to the FAA information regarding all delegation of authority to suppliers.

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§21.319   Design changes.

(a) Classification of design changes. (1) A “minor change” to the design of an article produced under a PMA is one that has no appreciable effect on the approval basis.

(2) A “major change” to the design of an article produced under a PMA is any change that is not minor.

(b) Approval of design changes. (1) Minor changes to the basic design of a PMA may be approved using a method acceptable to the FAA.

(2) The PMA holder must obtain FAA approval of any major change before including it in the design of an article produced under a PMA.

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§21.320   Changes in quality system.

After the issuance of a PMA—

(a) Each change to the quality system is subject to review by the FAA; and

(b) The holder of the PMA must immediately notify the FAA, in writing, of any change that may affect the inspection, conformity, or airworthiness of its article.

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