Canadian Aviation Regulations (SOR/96-433)

Manufacturer Certificate — Application, Issuance and Amendment

• 561.03 (1) An applicant for the issuance or amendment of a manufacturer certificate respecting an aeronautical product shall submit an application to the Minister that includes the documents specified in section 561.03 of Standard 561.

• (2) An applicant for the issuance or amendment of a manufacturer certificate respecting an aeronautical product shall

  • (a) be the holder of, or applicant for, a design approval for that aeronautical product; or

  • (b) have written authorization from the holder of a design approval to manufacture that aeronautical product.

• (3) An applicant for the issuance or amendment of a manufacturer certificate respecting an aeronautical product shall demonstrate that they have access to all present and future design data, process specifications and other related information necessary for the continuing airworthiness of the aeronautical product.

• (4) The Minister shall issue or amend a manufacturer certificate authorizing an applicant to manufacture the aeronautical products set out in the manufacturer certificate if the applicant meets the requirements of this Subpart.

• (5) A manufacturer certificate may authorize the manufacture of a limited number of an aeronautical product where

  • (a) an applicant has made an application for a design approval for that aeronautical product but it has not yet been issued; or

  • (b) an applicant is about to enter into a license agreement with the holder of the design approval for that aeronautical product.

• (6) Unless an expiry date is specified in the manufacturer certificate issued under subsection (4), the certificate shall remain in effect until it is surrendered by the manufacturer or suspended or cancelled.

• (7) A manufacturer certificate is not transferable.

• (8) Except as provided in section 561.06, the final assembly facilities for an aeronautical product specified in a manufacturer certificate shall be located in Canada.

Management Personnel

• 561.04 (1) The holder of a manufacturer certificate shall

  • (a) appoint a person to be responsible for all the activities performed under this Subpart and specified in the manual; and

  • (b) ensure that the person appointed has acquired experience in the areas of responsibility set out in subsection 561.04(1) of Standard 561.

  • (c) [Repealed, SOR/2022-246, s. 12]

• (2) [Repealed, SOR/2022-246, s. 12]

• (3) [Repealed, SOR/2022-246, s. 12]

• (4) [Repealed, SOR/2022-246, s. 12]

• (5) The holder of a manufacturer certificate shall provide the person appointed with the authority and the financial and human resources necessary to ensure that the requirements of this Subpart are met.

• (6) The person appointed may assign responsibility for the management of specific activities, systems or programs required by this Subpart to other persons, provided that the assignments and the scope of the assigned responsibilities are specified in the manual.

• (7) The holder of a manufacturer certificate shall ensure that no person is appointed under paragraph (1)(a) or remains responsible for the activities referred to in that paragraph if, at the time of their appointment or during their tenure, they have a record of conviction for

  • (a) an offence under section 7.3 of the Act; or

  • (b) two or more offences in respect of section 561.10 of these Regulations, not arising from a single occurrence.

Resources

561.05 The holder of a manufacturer certificate shall have, and ensure that any supplier referred to in section 561.13 has, the financial and human resources necessary for the manufacture and inspection of any aeronautical product specified in the manufacturer certificate, including those specified in section 561.05 of Standard 561.

Facilities Located in a Foreign State

561.06 If an arrangement exists between Canada and a foreign state concerning the manufacture of an aeronautical product, the holder of a manufacturer certificate may be authorized to perform their activities under the certificate in facilities located in that foreign state if the holder

• (a) submits a written application to that effect to the Minister;

• (b) gives, by a written agreement, an undertaking to the Minister to ensure that the Minister has access to those facilities to verify that the performance of the activities complies with the requirements of the Act and these Regulations, as if those facilities were located in Canada; and

• (c) undertakes to pay the expenses referred to in paragraphs 104.04(1)(a) and (b) incurred by the Department of Transport under paragraph (b).

Manual

• 561.07 (1) The holder of a manufacturer certificate shall establish, maintain and require the use of a manual that must include the information set out in section 561.07 of Standard 561 and that sets out policies and procedures respecting the construction and inspection of the aeronautical products specified in the manufacturer certificate.

• (2) Subject to subsection (4), the person appointed under paragraph 561.04(1)(a) shall ensure that any person who performs work under a manufacturer certificate complies with the manual.

• (3) [Repealed, SOR/2019-295, s. 10]

• (4) Subject to the following conditions, the holder of a manufacturer certificate and any person who performs work under a manufacturer certificate may temporarily be authorized to use alternative policies and procedures to comply with subsections (2) and (3):

  • (a) they have determined that, as a result of unforeseen or temporary circumstances, compliance with the manual would be impossible or unreasonable;

  • (b) they believe on reasonable grounds that the safety of the aeronautical product can be achieved by complying with the alternative policies and procedures;

  • (c) they have notified the Minister in writing; and

  • (d) the Minister has notified them in writing that they can use those alternative policies and procedures.

• (5) The holder of a manufacturer certificate shall submit the manual and any subsequent amendment to the Minister for approval.

• (6) The Minister shall approve the manual and any subsequent amendment if they meet the requirements of this Subpart and Standard 561.

• (7) If the manual no longer meets the requirements of this Subpart or Standard 561, the holder of a manufacturer certificate shall

  • (a) submit an amendment to the manual for the Minister’s approval; or

  • (b) amend the manual immediately if instructed to do so by the Minister.

• (8) The person who has been assigned the responsibility under subsection 561.04(6) shall amend each copy of the manual within 30 days after receiving the Minister’s approval of an amendment to it.

• (9) A manual may incorporate other documents by reference if it includes policies and procedures to control the incorporated material.

• (10) The person appointed under paragraph 561.04(1)(a) shall ensure that any part of the manual or incorporated document that is relevant to the work to be performed is made available to each person who performs that work.

Production Control System

• 561.08 (1) The holder of a manufacturer certificate shall establish and maintain a production control system that consists of systems and procedures set out in section 561.08 of Standard 561 to ensure that aeronautical products comply with these Regulations throughout the manufacturing process.

• (2) The production control system shall be under the control of

  • (a) the person appointed under paragraph 561.04(1)(a); or

  • (b) a person assigned the responsibility for the management of the production control system under subsection 561.04(6).

• (3) The person referred to in subsection (2) who has control of the production control system shall ensure that the activities carried out under the manufacturer certificate for which they have been assigned responsibility are in compliance with this Subpart.

Quality Assurance Program

• 561.09 (1) The holder of a manufacturer certificate shall, in order to ensure that all aspects of the activities carried out under the manufacturer certificate continue to comply with these Regulations, establish and maintain a quality assurance program, independent of the production control system, that

  • (a) is under the sole control of

    • (i) the person appointed under paragraph 561.04(1)(a), or

    • (ii) a person assigned the responsibility for the management of the quality assurance program under subsection 561.04(6); and

  • (b) meets the requirements specified in section 561.09 of Standard 561.

• (2) The person referred to in paragraph (1)(a) shall ensure that records related to the findings from the quality assurance program are distributed to the appropriate manager for corrective action and follow-up in accordance with the procedures specified in the manual.

• (3) The person referred to in paragraph (1)(a) shall establish and maintain an audit system that consists of

  • (a) an initial audit, within 12 months after the day on which the manufacturer certificate is issued, that covers all aspects of the manufacturer’s activities;

  • (b) subsequent audits conducted at the intervals set out in the manual;

  • (c) a record of each occurrence of compliance or non-compliance found during an audit referred to in paragraph (a) or (b);

  • (d) procedures for ensuring that each finding of an audit is communicated to them;

  • (e) follow-up procedures for ensuring that corrective actions are effective; and

  • (f) a system for recording the findings of initial and periodic audits, corrective actions and follow-ups.

• (4) The records required under paragraph (3)(f) shall be retained for the greater of

  • (a) two audit cycles; and

  • (b) two years.

• (5) The quality assurance program duties related to specific tasks or activities shall be performed by persons who are not responsible for and have not been involved in the performance of the tasks or activities being audited.

Statement of Conformity

• 561.10 (1) No person shall sign a statement of conformity in respect of an aeronautical product unless

  • (a) the statement contains the elements referred to in section 561.10 of Standard 561;

  • (b) the person has been authorized to do so by the person in control of the production control system;

  • (c) the aeronautical product is specified in the manufacturer certificate; and

  • (d) the aeronautical product has been manufactured in accordance with this Subpart.

• (2) No person shall authorize a person to sign, on behalf of the holder of a manufacturer certificate, a statement of conformity unless the person being authorized has complied with the policies and procedures set out in the manual and has successfully completed the training required under section 561.11.

Training Program

561.11 The holder of a manufacturer certificate shall

• (a) establish and maintain a training program that includes the initial training, updating and any other training set out in section 561.11 of Standard 561 to ensure continued qualification that is appropriate to the function to be performed or supervised; and

• (b) ensure that persons who are authorized to perform or supervise the performance of any function required under this Subpart are trained in respect of the parts of the policies and procedures of the holder of the manufacturer certificate and the parts of these Regulations applicable to that function.