21.A.139 Quality System

(a) The production organisation shall demonstrate that it has established and is able to maintain a quality system. The quality system shall be documented. This quality system shall be such as to enable the organisation to ensure that each product, part or appliance produced by the organisation or by its partners, or supplied from or subcontracted to outside parties, conforms to the applicable design data and is in condition for safe operation, and thus exercise the privileges set forth in point 21.A.163.

(b) The quality system shall contain:

(1) as applicable within the scope of approval, control procedures for:

(i) document issue, approval, or change;

(ii) vendor and sub-contractor assessment audit and control;

(iii) verification that incoming products, parts, materials, and equipment, including items supplied new or used by buyers of products, are as specified in the applicable design data;

(iv) identification and traceability;

(v) manufacturing processes;

(vi) inspection and testing, including production flight tests;

(vii) calibration of tools, jigs, and test equipment;

(viii) non-conforming item control;

(ix) airworthiness co-ordination with the applicant for, or holder of, a design approval;

(x) records completion and retention;

(xi) personnel competence and qualification;

(xii) issue of airworthiness release documents;

(xiii) handling, storage and packing;

(xiv) internal quality audits and resulting corrective actions;

(xv) work within the terms of approval performed at any location other than the approved facilities;

(xvi) work carried out after completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;

(xvii) issue of permit to fly and approval of associated flight conditions.

The control procedures need to include specific provisions for any critical parts.