173
Federal Aviation Administration, DOT
§ 21.616
(b) The accountable manager speci-
fied in paragraph (a) of this section
must be responsible within the appli-
cant’s or production approval holder’s
organization for, and have authority
over, all production operations con-
ducted under this part. The account-
able manager must confirm that the
procedures described in the quality
manual required by § 21.608 are in place
and that the production approval hold-
er satisfies the requirements of the ap-
plicable 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
59032, Oct. 1, 2015]
§ 21.607
Quality system.
Each applicant for or holder of a TSO
authorization must establish a quality
system that meets the requirements of
§ 21.137.
§ 21.608
Quality manual.
Each applicant for or holder of a TSO
authorization 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.
§ 21.609
Location of or change to man-
ufacturing facilities.
(a) An applicant may obtain a TSO
authorization for manufacturing facili-
ties located outside of the United
States if the FAA finds no undue bur-
den in administering the applicable re-
quirements of Title 49 U.S.C. and this
subchapter.
(b) The TSO authorization holder
must obtain FAA approval before mak-
ing any changes to the location of any
of its manufacturing facilities.
(c) The TSO authorization holder
must immediately notify the FAA, in
writing, of any change to the manufac-
turing facilities that may affect the in-
spection, conformity, or airworthiness
of its product or article.
§ 21.610
Inspections and tests.
Each applicant for or holder of a TSO
authorization must allow the FAA to
inspect its quality system, facilities,
technical data, and any manufactured
articles and witness any tests, includ-
ing any inspections or tests at a sup-
plier facility, necessary to determine
compliance with this subchapter.
§ 21.611
Issuance.
If the FAA finds that the applicant
complies with the requirements of this
subchapter, the FAA issues a TSO au-
thorization to the applicant (including
all TSO deviations granted to the ap-
plicant).
§ 21.613
Duration.
(a) A TSO authorization or letter of
TSO design approval is effective until
surrendered, withdrawn, or otherwise
terminated by the FAA.
(b) If a TSO is revised or canceled,
the holder of an affected FAA letter of
acceptance of a statement of conform-
ance, TSO authorization, or letter of
TSO design approval may continue to
manufacture articles that meet the
original TSO without obtaining a new
acceptance, authorization, or approval
but must comply with the require-
ments of this chapter.
§ 21.614
Transferability.
The holder of a TSO authorization or
letter of TSO design approval may not
transfer the TSO authorization or let-
ter of TSO design approval.
§ 21.616
Responsibility of holder.
Each holder of a TSO authorization
must—
(a) Amend the document required by
§ 21.605 as necessary to reflect changes
in the organization and provide these
amendments to the FAA.
(b) Maintain a quality system in
compliance with the data and proce-
dures approved for the TSO authoriza-
tion;
(c) Ensure that each manufactured
article conforms to its approved design,
is in a condition for safe operation, and
meets the applicable TSO;
(d) Mark the TSO 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 TSO
article (e.g., sub-assemblies, compo-
nent parts, or replacement articles)
that leave the manufacturer’s facility
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14 CFR Ch. I (1–1–24 Edition)
§ 21.618
as FAA approved with the manufactur-
er’s part number and name, trademark,
symbol, or other FAA approved manu-
facturer’s identification;
(f) Have access to design data nec-
essary to determine conformity and
airworthiness for each article produced
under the TSO authorization. The man-
ufacturer must retain this data until it
no longer manufactures the article. At
that time, copies of the data must be
sent to the FAA;
(g) Retain its TSO authorization and
make it available to the FAA upon re-
quest; and
(h) Make available to the FAA infor-
mation regarding all delegation of au-
thority to suppliers.
§ 21.618
Approval for deviation.
(a) Each manufacturer who requests
approval to deviate from any perform-
ance standard of a TSO must show that
factors or design features providing an
equivalent level of safety compensate
for the standards from which a devi-
ation is requested.
(b) The manufacturer must send re-
quests for approval to deviate, together
with all pertinent data, to the FAA. If
the article is manufactured under the
authority of a foreign country or juris-
diction, the manufacturer must send
requests for approval to deviate, to-
gether with all pertinent data, through
the civil aviation authority of that
country or jurisdiction to the FAA.
[Docket No. FAA–2006–25877, Amdt. 21–92, 74
FR 53392, Oct. 16, 2009, as amended by Doc.
No. FAA–2018–0119, Amdt. 21–101, 83 FR 9169,
Mar. 5, 2018]
§ 21.619
Design changes.
(a)
Minor changes by the manufacturer
holding a TSO authorization. The manu-
facturer of an article under an author-
ization issued under this part may
make minor design changes (any
change other than a major change)
without further approval by the FAA.
In this case, the changed article keeps
the original model number (part num-
bers may be used to identify minor
changes) and the manufacturer must
forward to the FAA, any revised data
that are necessary for compliance with
§ 21.603(a).
(b)
Major changes by the manufacturer
holding a TSO authorization. Any design
change by the manufacturer extensive
enough to require a substantially com-
plete investigation to determine com-
pliance with a TSO is a major change.
Before making a major change, the
manufacturer must assign a new type
or model designation to the article and
apply for an authorization under
§ 21.603.
(c)
Changes by persons other than the
manufacturer. No design change by any
person (other than the manufacturer
who provided the statement of con-
formance for the article) is eligible for
approval under this part unless the per-
son seeking the approval is a manufac-
turer and applies under § 21.603(a) for a
separate TSO authorization. Persons
other than a manufacturer may obtain
approval for design changes under part
43 or under the applicable airworthi-
ness regulations of this chapter.
[Docket No. FAA–2006–25877, Amdt. 21–92, 74
FR 53392, Oct. 16, 2009, as amended by Doc.
No. FAA–2018–0119, Amdt. 21–101, 83 FR 9169,
Mar. 5, 2018; Doc. No. FAA–2022–1355, Amdt.
21–106, 87 FR 75710, Dec. 9, 2022]
§ 21.620
Changes in quality system.
After the issuance of a TSO author-
ization—
(a) Each change to the quality sys-
tem is subject to review by the FAA;
and
(b) The holder of the TSO authoriza-
tion must immediately notify the FAA,
in writing, of any change that may af-
fect the inspection, conformity, or air-
worthiness of its article.
§ 21.621
Issue of letters of TSO design
approval: Import articles.
(a) The FAA may issue a letter of
TSO design approval for an article—
(1) Designed and manufactured in a
foreign country or jurisdiction subject
to the export provisions of an agree-
ment with the United States for the ac-
ceptance of these articles for import;
and
(2) For import into the United States
if—
(i) The State of Design certifies that
the article has been examined, tested,
and found to meet the applicable TSO
or the applicable performance stand-
ards of the State of Design and any
other performance standards the FAA
may prescribe to provide a level of
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