What should an organisation do if it uses a recognised standard like ISO 9001 to meet the management system requirements for production?

The organisation should ensure that the existing quality system covers all the aspects defined in point 21L.A.124(b). For example, if ISO 9001 is used, the quality system should be expanded to include additional topics such as mandatory and voluntary reporting, control of work outside declared sites, collaboration with design approval holders, issuing certificates, incorporating airworthiness data, ground/flight tests, traceability procedures, and personnel training for certifying staff.

Which recognised standards are mentioned as acceptable for a production organisation's quality system?

ISO 9001, EN 9100, and ASTM F2972 are mentioned as recognised standards that may be used, provided they are relevant to the scope of work of the declared production organisation.

What additional topics must be added to an ISO 9001 quality system to demonstrate compliance with point 21L.A.124(b)?

The quality system should be expanded to include: mandatory and voluntary reporting per 21L.A.3; control of work outside declared operating sites; collaboration with design approval holders or design compliance declarants per 21L.A.122(c); issuing certificates per 21L.A.126; incorporation of airworthiness data per 21L.A.125(b); ground and/or production flight tests when applicable; traceability procedures with clear criteria; and personnel training and qualification procedures, especially for certifying staff per 21L.A.125(d).

Which point specifies the requirement for personnel training and qualification procedures for certifying staff?

Point 21L.A.125(d) specifies the requirement for personnel training and qualification procedures, especially for certifying staff.

What is the purpose of incorporating airworthiness data into production and inspection data as per point 21L.A.125(b)?

The guidance does not state the purpose; it only states that the quality system should include the incorporation of airworthiness data in production and inspection data as required by point 21L.A.125(b).

Which point requires the mandatory and voluntary reporting system in the quality system?

Point 21L.A.3 requires the mandatory and voluntary reporting system, as referenced in the guidance for expanding a quality system to meet 21L.A.124(b).

What is the scope of work for issuing certificates under point 21L.A.126?

The guidance states that the quality system should include the issue of certificates within the scope of work of point 21L.A.126, but it does not detail the scope itself.

GM2 21L.A.124(b) Management system for production

Q: What is the definition of traceability provided in this guidance material?

Traceability is defined as a means of establishing the origin of an article by reference to historical records for the purpose of providing evidence of conformity.

Q: Which point requires collaboration with the applicant for or holder of an approved design, or with the organisation that has declared design compliance?

Point 21L.A.122(c) requires such collaboration, as mentioned in the guidance for expanding a quality system to meet 21L.A.124(b).

Q: What is the requirement for ground tests and production flight tests under the management system?

When applicable, ground tests and/or production flight tests of products must be performed in accordance with the procedures defined by the applicant for, or holder of, the design approval or the declarant of a declaration of design compliance.

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GM2 21L.A.124(b) Management system for production

ED Decision 2023/013/R

USE OF RECOGNISED STANDARDS

An organisation that has a quality system designed to meet a recognised standard such as ISO 9001,
EN 9100, or ASTM F2972 (relevant to the scope of work of the declared production organisation), should ensure that the existing quality system covers all the aspects defined in point 21L.A.124(b).

For example, if the standard that is used is ISO 9001, the quality system should be expanded to include at least the following additional topics, as appropriate, in order to demonstrate compliance with the requirements of this Annex:

— mandatory and voluntary reporting system as required by point 21L.A.3;

— control of work occasionally performed outside the operating sites included in the declaration;

— collaboration with the applicant for, or holder of, an approved design, or with the organisation that has declared or intends to declare the compliance of a particular aircraft design as required by point 21L.A.122(c);

— issue certificates within the scope of work of point 21L.A.126;

— incorporation of airworthiness data in production and inspection data as required by point 21L.A.125(b);

— when applicable, ground test and/or production flight test of products in accordance with the procedures defined by the applicant for, or holder of, the design approval or the declarant of a declaration of design compliance;

— procedures for traceability including the definition of clear criteria of which items require such traceability; traceability is defined as a means of establishing the origin of an article by reference to historical records for the purpose of providing evidence of conformity; and

— personnel training and qualification procedures especially for certifying staff as required by point 21L.A.125(d).

Details

Source-Title: GM2 21L.A.124(b) Management system for production View latest amendments

Erulesid: ERULES-1963177438-22009 Compare versions

Domain: Initial airworthiness

Amendedby: Issue 1

Applicabilitydate: 21 October, 2023

Entryintoforcedate: 21 October, 2023

Regulatorysource: ED Decision 2023/013/R Navigate

Regulatorysubject: Part 21 Light

Typeofcontent: GM to IR (Guidance material to implementing rule)

Parentir: 21L.A.124 Management system for production

Origin: EASA

Category: EAR