Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council Text with EEA relevance

• (a) Examination
• (1) For a class 1 medical certificate:
• (i) a comprehensive eye examination shall form part of the initial examination and shall be undertaken when clinically indicated and periodically, depending on the refraction and the functional performance of the eye.
• (ii) a routine eye examination shall form part of all revalidation and renewal examinations.
• (iii) when holders are involved in single-pilot HEMS operations, a comprehensive eye examination shall be completed at the first revalidation or renewal examination after the age of 60 and every year thereafter.
• (2) For a class 2 medical certificate:
• (i) a routine eye examination shall form part of the initial and all revalidation and renewal examinations.
• (ii) a comprehensive eye examination shall be undertaken when clinically indicated.

- (b) Visual acuity

• (1) For a class 1 medical certificate:
• (i) Distant visual acuity, with or without correction, shall be 6/9 (0,7) or better in each eye separately and visual acuity with both eyes shall be 6/6 (1,0) or better.
• (ii) At the initial examination, applicants with substandard vision in one eye shall be assessed as unfit.
• (iii) At revalidation and renewal examinations, notwithstanding point (b)(1)(i), applicants with acquired substandard vision in one eye or acquired monocularity shall be referred to the medical assessor of the licensing authority and may be assessed as fit subject to a satisfactory ophthalmological evaluation.
• (2) For a class 2 medical certificate:
• (i) Distant visual acuity, with or without correction, shall be 6/12 (0,5) or better in each eye separately and visual acuity with both eyes shall be 6/9 (0,7) or better.
• (ii) Notwithstanding point (b)(2)(i), applicants with substandard vision in one eye or monocularity may be assessed as fit, in consultation with the medical assessor of the licensing authority and subject to a satisfactory ophthalmological evaluation.
• (3) Applicants shall be able to read an N5 chart or equivalent at 30-50 cm and an N14 chart or equivalent at 100 cm, if necessary with correction.

- (c) Refractive error and anisometropia

• (1) Applicants with refractive errors or anisometropia may be assessed as fit subject to satisfactory ophthalmic evaluation.
• (2) Notwithstanding point (c)(1), applicants for a class 1 medical certificate with any of the following medical conditions shall be referred to the medical assessor of the licensing authority and may be assessed as fit subject to a satisfactory ophthalmological evaluation:
• (i) myopia exceeding – 6.0 dioptres;
• (ii) astigmatism exceeding 2.0 dioptres;
• (iii) anisometropia exceeding 2.0 dioptres.
• (3) Notwithstanding point (c)(1), applicants for a class 1 medical certificate with hypermetropia exceeding + 5.0 dioptres shall be referred to the medical assessor of the licensing authority and may be assessed as fit subject to a satisfactory ophthalmological evaluation, provided that there are adequate fusional reserves, normal intraocular pressures and anterior angles and no significant pathology has been demonstrated. Notwithstanding point (b)(1)(i), corrected visual acuity in each eye shall be 6/6 or better.
• (4) Applicants with a clinical diagnosis of keratoconus may be assessed as fit subject to a satisfactory examination by an ophthalmologist. Such applicants for a class 1 medical certificate shall be referred to the medical assessor of the licensing authority.

- (d) Binocular function

• (1) Applicants for a class 1 medical certificate shall be assessed as unfit, where they do not have normal binocular function and that medical condition is likely to jeopardise the safe exercise of the privileges of the license, taking account of any appropriate corrective measures where relevant.
• (2) Applicants with diplopia shall be assessed as unfit.

• (e) Visual fields Applicants for a class 1 medical certificate shall be assessed as unfit, where they do not have normal fields of vision and that medical condition is likely to jeopardise the safe exercise of the privileges of the license, taking account of any appropriate corrective measures where relevant.

• (f) Eye surgery Applicants who have undergone eye surgery shall be assessed as unfit. However, they may be assessed as fit after full recovery of their visual function and subject to satisfactory ophthalmological evaluation.

• (g) Spectacles and contact lenses
• (1) If satisfactory visual function is achieved only with the use of correction, the spectacles or contact lenses shall provide optimal visual function, be well-tolerated and suitable for aviation purposes.
• (2) No more than one pair of spectacles shall be used to meet the visual requirements when exercising the privileges of the applicable licence(s).
• (3) For distant vision, spectacles or contact lenses shall be worn when exercising the privileges of the applicable licence(s).
• (4) For near vision, a pair of spectacles shall be kept available when exercising the privileges of the applicable licence(s).
• (5) A spare set of similarly correcting spectacles, for distant or near vision as applicable, shall be readily available for immediate use when exercising the privileges of the applicable licence(s).
• (6) If contact lenses are worn when exercising the privileges of the applicable licence(s), they shall be for distant vision, monofocal, and non-tinted and well-tolerated.
• (7) Applicants with a large refractive error shall use contact lenses or high-index spectacle lenses.
• (8) Orthokeratological lenses shall not be used.

MED.B.075   Colour vision

- (a) Applicants shall be assessed as unfit, where they cannot demonstrate their ability to readily perceive the colours that are necessary for the safe exercise of the privileges of the licence.

• (b) Examination and assessment
• (1) Applicants shall be subjected to the Ishihara test for the initial issue of a medical certificate. For class 1 medical certificate holders involved in single-pilot HEMS operations, a colour vision assessment shall be completed at the first revalidation or renewal examination after the age of 60 and every year thereafter. Applicants who pass that test may be assessed as fit.
• (2) For a class 1 medical certificate:
• (i) Applicants who do not pass the Ishihara test shall be referred to the medical assessor of the licensing authority and shall undergo further colour perception testing to establish whether they are colour safe.
• (ii) Applicants shall be normal trichromats or shall be colour safe.
• (iii) Applicants who fail further colour perception testing shall be assessed as unfit.
• (3) For a class 2 medical certificate:
• (i) Applicants who do not pass the Ishihara test shall undergo further colour perception testing to establish whether they are colour safe.
• (ii) Applicants who do not have satisfactory perception of colours shall be limited to exercising the privileges of the applicable licence in daytime only.

MED.B.080   Otorhinolaryngology (ENT)

• (a) Examination
• (1) Applicants' hearing shall be tested at all examinations.
• (i) For a class 1 medical certificate, and for a class 2 medical certificate when an instrument rating or a basic instrument rating is to be added to the licence, hearing shall be tested with pure-tone audiometry at the initial examination, then every 5 years until the licence holder reaches the age of 40, and then every 2 years until the licence holder reaches the age of 60 and every year thereafter.
• (ii) When tested on a pure-tone audiometer, initial applicants shall not have a hearing loss of more than 35 dB at any of the frequencies 500, 1 000 or 2 000 Hz, or more than 50 dB at 3 000 Hz, in either ear separately. Applicants for revalidation or renewal with greater hearing loss shall demonstrate satisfactory functional hearing ability.
• (2) A comprehensive ear, nose and throat examination shall be undertaken for the initial issue of a class 1 medical certificate and periodically thereafter when clinically indicated.
• (3) For class 1 medical certificate holders involved in single-pilot HEMS operations, a comprehensive ear, nose and throat examination shall be completed at the first revalidation or renewal examination after the age of 60.

- (b) Applicants with any of the following medical conditions shall undergo further examination to establish that the medical condition does not interfere with the safe exercise of the privileges of the applicable licence(s):

• (1) hypoacusis;
• (2) an active pathological process of the internal or middle ear;
• (3) unhealed perforation or dysfunction of the tympanic membrane(s);
• (4) dysfunction of the Eustachian tube(s);
• (5) disturbance of vestibular function;
• (6) significant restriction of the nasal passages;
• (7) sinus dysfunction;
• (8) significant malformation or significant infection of the oral cavity or upper respiratory tract;
• (9) significant disorder of speech or voice;
• (10) any sequelae of surgery of the internal or middle ear.

• (c) Aero-medical assessment
• (1) Applicants for a class 1 medical certificate with any of the medical conditions specified in points (1), (4) and (5) of point (b) shall be referred to the medical assessor of the licensing authority.
• (2) The fitness of applicants for a class 2 medical certificate with any of the medical conditions specified in point (4) and (5) of point (b) shall be assessed in consultation with the medical assessor of the licensing authority.
• (3) The fitness of applicants for a class 2 medical certificate for an instrument rating or en route instrument rating to be added to the licence with the medical condition specified in point (1) of point (b) shall be assessed in consultation with the medical assessor of the licensing authority.

MED.B.085   Dermatology

Applicants shall be assessed as unfit, where they have an established dermatological condition which is likely to jeopardise the safe exercise of the privileges of the licence.

MED.B.090   Oncology

• (a) Before further consideration is given to their application, applicants with primary or secondary malignant disease shall undergo satisfactory oncological evaluation. Such applicants for a class 1 medical certificate shall be referred to the medical assessor of the licensing authority. Such applicants for a class 2 medical certificate shall be assessed in consultation with the medical assessor of the licensing authority.

• (b) Applicants with a documented medical history or clinical diagnosis of an intracerebral malignant tumour shall be assessed as unfit.

SECTION 3

Specific requirements for LAPL medical certificates

MED.B.095   Medical examination and assessment of applicants for LAPL medical certificates

• (a) An applicant for a LAPL medical certificate shall be assessed based on aero-medical best practice.

• (b) Special attention shall be given to the applicant's complete medical history.

• (c) The initial assessment, all subsequent re-assessments after the licence holder reaches the age of 50 and any assessments in cases where the medical history of the applicant is not available to the examiner shall include at least all of the following:
• (1) clinical examination;
• (2) blood pressure;
• (3) urine test;
• (4) vision;
• (5) hearing ability.

• (d) After the initial assessment, subsequent re-assessments until the licence holder reaches the age of 50 shall include at least both of the following:
• (1) an assessment of the LAPL holder's medical history;
• (2) the items specified in point(c) as deemed necessary by the AeMC, AME or GMP in accordance with aero-medical best practice.

SUBPART C

REQUIREMENTS FOR MEDICAL FITNESS OF CABIN CREW

SECTION 1

General requirements

MED.C.001   General

Cabin crew members shall only perform the duties and responsibilities required by aviation safety rules on an aircraft if they comply with the applicable requirements of this Part.

MED.C.005   Aero-medical assessments

• (a) Cabin crew members shall undergo aero-medical assessments to verify that they are free from any physical or mental illness which might lead to incapacitation or an inability to perform their assigned safety duties and responsibilities.

• (b) Each cabin crew member shall undergo an aero-medical assessment before being first assigned to duties on an aircraft, and after that at intervals of maximum 60 months.

- (c) Aero-medical assessments shall be conducted by an AME, AeMC, or by an OHMP if the requirements of MED.D.040 are complied with.

SECTION 2

Requirements for aero-medical assessment of cabin crew

MED.C.020   General

Cabin crew members shall be free from any:

• (a) abnormality, congenital or acquired;

• (b) active, latent, acute or chronic disease or disability;

• (c) wound, injury or sequelae from operation; and

• (d) effect or side effect of any prescribed or non-prescribed therapeutic, diagnostic or preventive medication taken that would entail a degree of functional incapacity which might lead to incapacitation or an inability to discharge their safety duties and responsibilities.

MED.C.025   Content of aero-medical assessments

• (a) An initial aero-medical assessment shall include at least:

• (1) an assessment of the applicant cabin crew member’s medical history; and

• (2) a clinical examination of the following:
• (i) cardiovascular system;
• (ii) respiratory system;
• (iii) musculoskeletal system;
• (iv) otorhino-laryngology;
• (v) visual system; and
• (vi) colour vision.

- (b) Each subsequent aero-medical re-assessment shall include:

• (1) an assessment of the cabin crew member’s medical history; and

- (2) a clinical examination if deemed necessary in accordance with aero-medical best practice.

• (c) For the purpose of (a) and (b), in case of any doubt or if clinically indicated, a cabin crew member’s aero-medical assessment shall also include any additional medical examination, test or investigation that are considered necessary by the AME, AeMC or OHMP.

SECTION 3

Additional requirements for applicants for, or holders of, a cabin crew attestation

MED.C.030   Cabin crew medical report

• (a) After completion of each aero-medical assessment, applicants for, and holders of, a cabin crew attestation:

• (1) shall be provided with a cabin crew medical report by the AME, AeMC or OHMP; and

• (2) shall provide the related information, or a copy of their cabin crew medical report to the operator(s) employing their services.

• (b) Cabin crew medical report

A cabin crew medical report shall indicate the date of the aero-medical assessment, whether the cabin crew member has been assessed fit or unfit, the date of the next required aero-medical assessment and, if applicable, any limitation(s). Any other elements shall be subject to medical confidentiality in accordance with MED.A.015.

MED.C.035   Limitations

- (a) If holders of a cabin crew attestation do not fully comply with the medical requirements specified in Section 2, the AME, AeMC or OHMP shall consider whether they may be able to perform cabin crew duties safely if complying with one or more limitations.

• (b) Any limitation(s) to the exercise of the privileges granted by the cabin crew attestation shall be specified on the cabin crew medical report and shall only be removed by an AME, AeMC or by an OHMP in consultation with an AME.

SUBPART D

AERO-MEDICAL EXAMINERS, GENERAL MEDICAL PRACTITIONERS, OCCUPATIONAL HEALTH MEDICAL PRACTITIONERS

SECTION 1

Aero-Medical Examiners

MED.D.001   Privileges

• (a) The privileges of holders of an aero-medical examiner (AME) certificate are to issue, revalidate and renew class 2 medical certificates and LAPL medical certificates and to conduct the relevant medical examinations and assessments.

• (b) Holders of an AME certificate may apply for an extension of their privileges to include medical examinations for the revalidation and renewal of class 1 medical certificates, if they comply with the requirements set out in point MED.D.015.

• (c) The privileges of a holder of an AME certificate referred to in points (a) and (b) shall include the privileges to conduct cabin crew members' aero-medical examinations and assessments and to provide the related cabin crew members' medical reports, as applicable, in accordance with this Annex (Part-MED).

• (d) The scope of the privileges of the holder of an AME certificate, and any condition thereof, shall be specified in that certificate.

• (e) A holder of an AME certificate shall not at any time hold more than one AME certificate issued in accordance with this Regulation.

• (f) Holders of an AME certificate shall not undertake aero-medical examinations and assessments in a Member State other than the Member State that issued their AME certificate, unless they have completed all the following steps:
• (1) they have been granted access by the other Member State concerned to exercise their professional activities as a specialised doctor;
• (2) they have informed the competent authority of that other Member State of their intention to conduct aero-medical examinations and assessments and to issue medical certificates within the scope of their privileges as AME;
• (3) they have received a briefing from the competent authority of that other Member State.

MED.D.005   Application

• (a) An application for an AME certificate or for an extension of the privileges of an AME certificate shall be made in a form and manner specified by the competent authority.

• (b) Applicants for an AME certificate shall provide the competent authority with:
• (1) their personal details and professional address;
• (2) documentation demonstrating that they comply with the requirements of point MED.D.010, including evidence of successful completion of the training course in aviation medicine appropriate to the privileges they apply for;
• (3) a written declaration that, once the AME certificate has been issued, the AME will issue medical certificates on the basis of the requirements of this Regulation.

• (c) When AMEs undertake aero-medical examinations in more than one location, they shall provide the competent authority with relevant information regarding all practice locations and practice facilities.

MED.D.010   Requirements for the issue of an AME certificate

Applicants shall be issued an AME certificate, where they meet all of the following conditions:

• (a) they are fully qualified and licensed for the practice of medicine and have evidence of completion of specialist medical training;

• (b) they have successfully completed a basic training course in aviation medicine, including practical training in the examination methods and aero-medical assessments;

• (c) they have demonstrated to the competent authority that they:
• (1) have adequate facilities, procedures, documentation and functioning equipment suitable for aero-medical examinations;
• (2) have in place the necessary procedures and conditions to ensure medical confidentiality.

MED.D.011   Privileges of an AME certificate holder

Through the issuance of an AME certificate, the holder shall be granted the privileges to initially issue, revalidate and renew all of the following:

• (a) class 2 medical certificates;

• (b) LAPL medical certificates;

• (c) cabin crew members' medical reports.

MED.D.015   Requirements for the extension of privileges

Applicants shall be issued an AME certificate extending their privileges to the revalidation and renewal of class 1 medical certificates where they meet all of the following conditions:

• (a) they hold a valid AME certificate;

- (b) they conducted at least 30 examinations for the issue, revalidation or renewal of class 2 medical certificates or equivalent over a period of no more than 3 years preceding the application;

- (c) they successfully completed an advanced training course in aviation medicine, including practical training in the examination methods and aero-medical assessments;

- (d) they have successfully completed practical training of a duration of at least 2 days, either at an AeMC or under the supervision of the competent authority.

MED.D.020   Training courses in aviation medicine

• (a) Training courses in aviation medicine refered to in MED.D.010(b) and MED.D.015 (c) shall only be provided after the prior approval of the course by the competent authority of the Member State where the training organisation has its principal place of business. In order to obtain such approval, the training organisation shall demonstrate that the course syllabus contains the learning objectives to acquire the necessary competencies and that the persons in charge of providing the training have adequate knowledge and experience.

• (aa) For demonstrating compliance with points MED.D.010(b) and MED.D.015(c), an aviation medicine training course completed by an applicant outside the territories for which Member States are responsible under the Chicago Convention may be accepted by the competent authority, provided that the following conditions are met:
• (i) the competent authority has assessed and verified the course syllabus in accordance with point ARA.MED.200(c)(1) of Annex VI;
• (ii) the applicant has completed a specific training module on the aero-medical requirements detailed in this Annex (Part-MED) as provided by the competent authority.

• (b) Except in the case of refresher training, the courses shall be concluded by a written examination on the subjects included in the course content.

• (c) The training organisation shall issue a certificate of successful completion to participants when they have obtained a pass in the examination.

MED.D.025   Changes to the AME certificate

- (a) Holders of an AME certificate shall, without undue delay, notify the competent authority of the following circumstances which could affect their AME certificate:

• (1) the AME is subject to disciplinary proceedings or investigation by a medical regulatory body;
• (2) there are changes to the conditions under which the certificate was granted, including the content of the statements provided with the application;
• (3) the requirements for the issuance of the AME certificate are no longer met;
• (4) there is a change to the aero-medical examiner's practice location(s) or correspondence address.

• (b) Failure to notify the competent authority in accordance with point (a) shall result in the suspension or revocation of the AME certificate in accordance with point ARA.MED.250 of Annex II (Part-ARA).

MED.D.030   Validity of AME certificates

An AME certificate shall be valid for a period of 3 years, unless the competent authority decides to reduce that period for duly justified reasons related to the individual case.

Upon application by the holder, the certificate shall be:

- (a) revalidated, provided that the holder:

• (1) continues to fulfil the general conditions required for medical practice and maintains his or her licence for the practice of medicine;
• (2) has undertaken refresher training in aviation medicine within the last 3 years;
• (3) has performed at least 10 aero-medical examinations or equivalent every year;
• (4) remains in compliance with the terms of the certificate;
• (5) exercises the privileges in accordance with the requirements of this Annex (Part-MED);
• (6) has demonstrated that he or she maintains his or her aero-medical competency in accordance with the procedure established by the competent authority.

- (b) renewed, provided that the holder complies with either the requirements for revalidation set out in point (a) or with all of the following requirements:

• (1) continues to fulfil the general conditions required for medical practice and maintains his or her licence for the practice of medicine;
• (2) has undertaken refresher training in aviation medicine within the previous year;
• (3) has successfully completed practical training within the previous year, either at an AeMC or under the supervision of the competent authority;
• (4) remains in compliance with the requirements of point MED.D.010;
• (5) has demonstrated that he or she maintains his or her aero-medical competency in accordance with the procedure established by the competent authority.

SECTION 2

General Medical Practitioners

MED.D.035   Requirements for general medical practitioners

General medical practitioners (GMPs) may act as AMEs for issuing LAPL medical certificates, where they meet all of the following conditions:

• (a) they exercise their activity in a Member State where GMPs have access to the full medical records of applicants;

- (b) they exercise their activity in accordance with any additional requirements established in the national law of the Member State of their competent authority;

• (c) they are fully qualified and licensed for the practice of medicine in accordance with national law of the Member State of their competent authority;

• (d) they have notified the competent authority before starting such activity.

SECTION 3

Occupational Health Medical Practitioners

MED.D.040   Requirements for occupational health medical practitioners

In Member States where the competent authority is satisfied that the requirements of the national health system applicable to occupational health medical practitioners (OHMPs) are such as to ensure compliance with the requirements of this Annex (Part-MED) applicable to OHMPs, OHMPs may conduct aero-medical assessments of cabin crew, provided that:

• (a) they are fully qualified and licensed in the practice of medicine and qualified in occupational medicine;

• (b) the in-flight working environment and safety duties of the cabin crew were included in their occupational medicine qualification syllabus or other training or operational experience;

• (c) they have notified the competent authority before starting such activity.

ANNEX V

QUALIFICATION OF CABIN CREW INVOLVED IN COMMERCIAL AIR TRANSPORT OPERATIONS

[PART-CC]

SUBPART GEN

GENERAL REQUIREMENTS

CC.GEN.001 Competent authority

For the purpose of this Part, the competent authority shall be the authority designated by the Member State where a person applies for the issue of a cabin crew attestation.

CC.GEN.005 Scope

This Part establishes the requirements for the issue of cabin crew attestations and the conditions for their validity and use by their holders.

CC.GEN.015 Application for a cabin crew attestation

The application for a cabin crew attestation shall be made in a form and manner established by the competent authority.

CC.GEN.020 Minimum age

The applicant for a cabin crew attestation shall be at least 18 years of age.

CC.GEN.025 Privileges and conditions

• (a)The privileges of holders of a cabin crew attestation are to act as cabin crew members in commercial air transport operation of aircraft referred to in Article 4(1)(b) and (c) of Regulation (EC) No 216/2008.

• (b)Cabin crew members may exercise the privileges specified in (a) only if they:

• (1) hold a valid cabin crew attestation as specified in CC.CCA.105; and

• (2) comply with CC.GEN.030, CC.TRA.225 and the applicable requirements of Part-MED.

CC.GEN.030 Documents and record-keeping

To show compliance with the applicable requirements as specified in CC.GEN.025(b), each holder shall keep, and provide upon request, the cabin crew attestation, the list and the training and checking records of his/her aircraft type or variant qualification(s), unless the operator employing his/her services keeps such records and can make them readily available upon request by a competent authority or by the holder.

SUBPART CCA

SPECIFIC REQUIREMENTS FOR THE CABIN CREW ATTESTATION

CC.CCA.100 Issue of the cabin crew attestation

• (a)Cabin crew attestations shall only be issued to applicants who have passed the examination following completion of the initial training course in accordance with this Part.

• (b)Cabin crew attestations shall be issued:

• (1) by the competent authority; and/or

- (2) by an organisation approved to do so by the competent authority.

CC.CCA.105 Validity of the cabin crew attestation

The cabin crew attestation shall be issued with unlimited duration and shall remain valid unless:

• (a) it is suspended or revoked by the competent authority; or

- (b) its holder has not exercised the associated privileges during the preceding 60 months on at least one aircraft type.

CC.CCA.110 Suspension and revocation of the cabin crew attestation

- (a)If holders do not comply with this Part, their cabin crew attestation may be suspended or revoked by the competent authority.

• (b)In case of suspension or revocation of their cabin crew attestation by the competent authority, holders shall:

• (1) be informed in writing of this decision, and of their right of appeal in accordance with national law;

• (2) not exercise the privileges granted by their cabin crew attestation;

• (3) inform, without undue delay, the operator(s) employing their services; and

• (4) return their attestation in accordance with the applicable procedure established by the competent authority.

SUBPART TRA

TRAINING REQUIREMENTS FOR CABIN CREW ATTESTATION APPLICANTS AND HOLDERS

CC.TRA.215 Provision of training

Training required in this Part shall be:

• (a) provided by training organisations or commercial air transport operators approved to do so by the competent authority;

• (b) performed by personnel suitably experienced and qualified for the training elements to be covered; and

• (c) conducted according to a training programme and syllabus documented in the organisation's approval.

CC.TRA.220 Initial training course and examination

• (a)Applicants for a cabin crew attestation shall complete an initial training course to familiarise themselves with the aviation environment and to acquire sufficient general knowledge and basic proficiency required to perform the duties and discharge the responsibilities related to the safety of passengers and flight during normal, abnormal and emergency operations.

• (b)The programme of the initial training course shall cover at least the elements specified in Appendix 1 to this Part. It shall include theoretical and practical training.

- (c)Applicants for a cabin crew attestation shall undergo an examination covering all elements of the training programme specified in (b), except CRM training, to demonstrate that they have attained the level of knowledge and proficiency required in (a).

CC.TRA.225 Aircraft type or variant qualification(s)

• (a)Holders of a valid cabin crew attestation shall only operate on an aircraft if they are qualified in accordance with the applicable requirements of Part-ORO.

• (b)To be qualified for an aircraft type or a variant, the holder:

- (1) shall comply with the applicable training, checking and validity requirements, covering as relevant to the aircraft to be operated:

• (i) aircraft-type specific training, operator conversion training and familiarisation;
• (ii) differences training;
• (iii) recurrent training; and

• (2) shall have operated within the preceding 6 months on the aircraft type, or shall have completed the relevant refresher training and checking before operating again on that aircraft type.

Appendix 1 to Part-CC

Initial training course and examination

TRAINING PROGRAMME

The training programme of the initial training course shall include at least the following:

• 1.1.aviation terminology, theory of flight, passenger distribution, areas of operation, meteorology and effects of aircraft surface contamination;

- 1.2.aviation regulations relevant to cabin crew and the role of the competent authority;

• 1.3.duties and responsibilities of cabin crew during operations and the need to respond promptly and effectively to emergency situations;

• 1.4.continuing competence and fitness to operate as a cabin crew member, including as regards flight and duty time limitations and rest requirements;

- 1.5.the importance of ensuring that relevant documents and manuals are kept up-to-date, with amendments provided by the operator as applicable;

• 1.6.the importance of cabin crew performing their duties in accordance with the operations manual of the operator;

• 1.7.the importance of the cabin crew’s pre-flight briefing and the provision of necessary safety information with regards to their specific duties; and

• 1.8.the importance of identifying when cabin crew members have the authority and responsibility to initiate an evacuation and other emergency procedures.

During training, emphasis shall be placed on the importance of effective communication between cabin crew and flight crew, including communication techniques, common language and terminology.

This course shall be conducted by at least one cabin crew CRM instructor. The training elements shall be covered in depth and shall include at least the following:

• 3.1. General: human factors in aviation, general instructions on CRM principles and objectives, human performance and limitations;

• 3.2. Relevant to the individual cabin crew member: personality awareness, human error and reliability, attitudes and behaviours, self-assessment; stress and stress management; fatigue and vigilance; assertiveness; situation awareness, information acquisition and processing.

• 4.1.the importance of correct seat allocation with reference to aeroplane mass and balance, special categories of passengers and the necessity of seating able-bodied passengers adjacent to unsupervised exits;

• 4.2.rules covering the safe stowage of cabin baggage and cabin service items and the risk of it becoming a hazard to occupants of the passenger compartment or otherwise obstruction or damaging emergency equipment or exits;

- 4.3.advice on the recognition and management of passengers who are, or become, intoxicated with alcohol or are under the influence of drugs or are aggressive;

• 4.4.precautions to be taken when live animals are carried in the passenger compartment;

• 4.5.duties to be undertaken in the event of turbulence, including securing the passenger compartment; and

• 4.6.methods used to motivate passengers and the crowd control necessary to expedite an emergency evacuation.

• 5.1.general instruction on aero-medical aspects and survival;

• 5.2.the physiological effects of flying with particular emphasis on hypoxia, oxygen requirements, Eustachian tubal function and barotraumas;

• 5.3.basic first-aid, including care of:

- (a) air sickness;

- (b) gastro-intestinal disturbances;

- (c) hyperventilation;

- (d) burns;

- (e) wounds;

• (f) the unconscious; and

- (g) fractures and soft tissue injuries;

- 5.4.in-flight medical emergencies and associated first-aid covering at least:

- (a) asthma;

• (b) stress and allergic reactions;

• (c) shock;

• (d) diabetes;

• (e) choking;

• (f) epilepsy;

- (g) childbirth;

• (h) stroke; and

• (i) heart attack;

• 5.5.the use of appropriate equipment including first-aid oxygen, first-aid kits and emergency medical kits and their contents;

- 5.6.practical cardio-pulmonary resuscitation training by each cabin crew member using a specifically designed dummy and taking account of the characteristics of an aircraft environment; and

• 5.7.travel health and hygiene, including:

• (a) hygiene on board;

• (b) risk of contact with infectious diseases and means to reduce such risks;

- (c) handling of clinical waste;

• (d) aircraft disinsection;

• (e) handling of death on board; and

• (f) alertness management, physiological effects of fatigue, sleep physiology, circadian rhythm and time zone changes.

7. General security aspects in aviation, including awareness of the provisions laid down in Regulation (EC) No 300/2008.

• 8.1.emphasis on the responsibility of cabin crew to deal promptly with emergencies involving fire and smoke and, in particular, emphasis on the importance of identifying the actual source of the fire;

- 8.2.the importance of informing the flight crew immediately, as well as the specific actions necessary for coordination and assistance, when fire or smoke is discovered;

• 8.3.the necessity for frequent checking of potential fire-risk areas including toilets, and the associated smoke detectors;

• 8.4.the classification of fires and the appropriate type of extinguishing agents and procedures for particular fire situations;

• 8.5.the techniques of application of extinguishing agents, the consequences of misapplication, and of use in a confined space including practical training in fire-fighting and in the donning and use of smoke protection equipment used in aviation; and

- 8.6.the general procedures of ground-based emergency services at aerodromes.

9. Survival training:

- 9.1.principles of survival in hostile environments (e.g. polar, desert, jungle, sea); and

• 9.2.water survival training which shall include the actual donning and use of personal flotation equipment in water and the use of slide-rafts or similar equipment, as well as actual practice in water.

ANNEX VI

AUTHORITY REQUIREMENTS FOR AIRCREW

[PART-ARA]

SUBPART GEN

GENERAL REQUIREMENTS

SECTION I

General

ARA.GEN.115   Oversight documentation

The competent authority shall provide all legislative acts, standards, rules, technical publications and related documents to relevant personnel in order to allow them to perform their tasks and to discharge their responsibilities.

ARA.GEN.120   Means of compliance

• (a) The Agency shall develop Acceptable Means of Compliance (AMC) that may be used to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules. When the AMC are complied with, the related requirements of the Implementing Rules are met.

• (b) Alternative means of compliance may be used to establish compliance with the Implementing Rules.

• (c) The competent authority shall establish a system to consistently evaluate that all alternative means of compliance used by itself or by organisations and persons under its oversight allow the establishment of compliance with Regulation (EC) No 216/2008 and its Implementing Rules.

- (d) The competent authority shall evaluate all alternative means of compliance proposed by an organisation in accordance with ORA.GEN.120 by analysing the documentation provided and, if considered necessary, conducting an inspection of the organisation.

When the competent authority finds that the alternative means of compliance are in accordance with the Implementing Rules, it shall without undue delay: - (1) notify the applicant that the alternative means of compliance may be implemented and, if applicable, amend the approval or certificate of the applicant accordingly; and - (2) notify the Agency of their content, including copies of all relevant documentation; - (3) inform other MS about alternative means of compliance that were accepted.

• (e) When the competent authority itself uses alternative means of compliance to achieve compliance with Regulation (EC) No 216/2008 and its Implementing Rules it shall:
• (1) make them available to all organisations and persons under its oversight; and
• (2) without undue delay notify the Agency. The competent authority shall provide the Agency with a full description of the alternative means of compliance, including any revisions to procedures that may be relevant, as well as an assessment demonstrating that the Implementing Rules are met.

ARA.GEN.125   Information to the Agency

• (a) The competent authority shall notify the Agency in case of any significant problems with the implementation of Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof within 30 days from the time the authority became aware of the problems.

• (b) Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council ([^E0022]) and the delegated and implementing acts adopted on the basis thereof, the competent authority shall provide the Agency with safety-significant information stemming from the occurrence reports stored in the national database, as soon as possible.

• (c) The competent authority of the Member State shall provide the Agency as soon as possible with safety-significant information stemming from the information security reports it has received pursuant to point IS.I.OR.230 of Annex II (Part-IS.I.OR) to Implementing Regulation (EU) 2023/203.

ARA.GEN.135   Immediate reaction to a safety problem

- (a) Without prejudice to Regulation (EU) No 376/2014 and the delegated and implementing acts adopted on the basis thereof, the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information.

- (b) The Agency shall implement a system to appropriately analyse any relevant safety information received and without undue delay provide to Member States and the Commission any information, including recommendations or corrective actions to be taken, necessary for them to react in a timely manner to a safety problem involving products, parts, non-installed equipment, persons or organisations subject to Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.

• (c) Upon receiving the information referred to in (a) and (b), the competent authority shall take adequate measures to address the safety problem.

• (d) Measures taken under point (c) shall immediately be notified to all persons or organisations that need to comply with them under Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. The competent authority shall also notify those measures to the Agency and, when combined action is required, the other Member States concerned.

ARA.GEN.135A   Immediate reaction to an information security incident or vulnerability with an impact on aviation safety

- (a) The competent authority shall implement a system to appropriately collect, analyse, and disseminate information related to information security incidents and vulnerabilities with a potential impact on aviation safety that are reported by organisations. This shall be done in coordination with any other relevant authorities responsible for information security or cybersecurity within the Member State to increase the coordination and compatibility of reporting schemes.

- (b) The Agency shall implement a system to appropriately analyse any relevant safety-significant information received in accordance with point ARA.GEN.125(c), and without undue delay provide the Member States and the Commission with any information, including recommendations or corrective actions to be taken, necessary for them to react in a timely manner to an information security incident or vulnerability with a potential impact on aviation safety involving products, parts, non-installed equipment, persons or organisations subject to Regulation (EU) 2018/1139 and its delegated and implementing acts.

- (c) Upon receiving the information referred to in points (a) and (b), the competent authority shall take adequate measures to address the potential impact on aviation safety of the information security incident or vulnerability.

- (d) Measures taken in accordance with point (c) shall immediately be notified to all persons or organisations that shall comply with them under Regulation (EU) 2018/1139 and its delegated and implementing acts. The competent authority of the Member State shall also notify those measures to the Agency and, when combined action is required, the competent authorities of the other Member States concerned.

SECTION II

Management

ARA.GEN.200   Management system

- (a) The competent authority shall establish and maintain a management system, including as a minimum:

• (1) documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. The procedures shall be kept up to date and serve as the basic working documents within that competent authority for all related tasks;
• (2) a sufficient number of personnel to perform its tasks and discharge its responsibilities. Such personnel shall be qualified to perform their allocated tasks and have the necessary knowledge, experience, initial and recurrent training to ensure continuing competence. A system shall be in place to plan the availability of personnel, in order to ensure the proper completion of all tasks;
• (3) adequate facilities and office accommodation to perform the allocated tasks;
• (4) a function to monitor compliance of the management system with the relevant requirements and adequacy of the procedures including the establishment of an internal audit process and a safety risk management process. Compliance monitoring shall include a feedback system of audit findings to the senior management of the competent authority to ensure implementation of corrective actions as necessary; and
• (5) a person or group of persons, ultimately responsible to the senior management of the competent authority for the compliance monitoring function.

• (b) The competent authority shall, for each field of activity including management system, appoint one or more persons with the overall responsibility for the management of the relevant task(s).

- (c) The competent authority shall establish procedures for participation in a mutual exchange of all necessary information and assistance with other competent authorities concerned, whether from within the Member State or in other Member States, including the following information:

• (1) on all findings raised, corrective follow-up actions taken pursuant to such findings and enforcement measures taken as a result of oversight of persons and organisations exercising activities in the territory of a Member State but certified by or having made declarations to the competent authority of another Member State or the Agency;
• (2) stemming from mandatory and voluntary occurrence reporting as required by point ORA.GEN.160 of Annex VII.

- (d) A copy of the procedures related to the management system and their amendments shall be made available to the Agency for the purpose of standardisation.

- (e) In addition to the requirements contained in point (a), the management system established and maintained by the competent authority shall comply with Annex I (Part-IS.AR) to Implementing Regulation (EU) 2023/203 in order to ensure the proper management of information security risks which may have an impact on aviation safety.

ARA.GEN.205   Allocation of tasks

- (a) Tasks related to the initial certification or continuing oversight of persons or organisations subject to Regulation (EC) No 216/2008 and its Implementing Rules shall be allocated by Member States only to qualified entities. When allocating tasks, the competent authority shall ensure that it has:

• (1) a system in place to initially and continuously assess that the qualified entity complies with Annex V to Regulation (EC) No 216/2008. This system and the results of the assessments shall be documented;
• (2) established a documented agreement with a the qualified entity, approved by both parties at the appropriate management level, which clearly defines:
• (i) the tasks to be performed;
• (ii) the declarations, reports and records to be provided;
• (iii) the technical conditions to be met in performing such tasks;
• (iv) the related liability coverage; and
• (v) the protection given to information acquired in carrying out such tasks.

• (b) The competent authority shall ensure that the internal audit process and a safety risk management process required by ARA.GEN.200(a)(4) cover all certification or continuing oversight tasks performed on its behalf.

• (c) With regard to the certification and oversight of the organisation’s compliance with point ORA.GEN.200A, the competent authority may allocate tasks to qualified entities in accordance with point (a), or to any relevant authority responsible for information security or cybersecurity within the Member State. When allocating tasks, the competent authority shall ensure that:
• (1) all aspects related to aviation safety are coordinated and taken into account by the qualified entity or relevant authority;
• (2) the results of the certification and oversight activities performed by the qualified entity or relevant authority are integrated in the overall certification and oversight files of the organisation;
• (3) its own information security management system established in accordance with point ARA.GEN.200(e) covers all the certification and continuing oversight tasks performed on its behalf.

ARA.GEN.210   Changes in the management system

- (a) The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof. That system shall enable it to take action as appropriate to ensure that its management system remains adequate and effective.

• (b) The competent authority shall update its management system to reflect any change to Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof in a timely manner, so as to ensure effective implementation.

- (c) The competent authority shall notify the Agency of changes affecting its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and the delegated and implementing acts adopted on the basis thereof.

ARA.GEN.220   Record-keeping

• (a) The competent authority shall establish a system of record-keeping providing for adequate storage, accessibility and reliable traceability of:
• (1) the management system’s documented policies and procedures;
• (2) training, qualification and authorisation of its personnel;
• (3) the allocation of tasks, covering the elements required by ARA.GEN.205 as well as the details of tasks allocated;
• (4) certification and declaration processes as well as oversight of certified and declared organisations;
• (5) processes for issuing personnel licences, ratings, certificates and attestations and for the continuing oversight of the holders of those licences, ratings, certificates and attestations;
• (6) processes for issuing FSTD qualification certificates and for the continuing oversight of the FSTD and of the organisation operating it;
• (7) oversight of persons and organisations exercising activities within the territory of the Member State, but overseen or certified by the competent authority of another Member State or the Agency, as agreed between these authorities;
• (8) the evaluation and notification to the Agency of alternative means of compliance proposed by organisations and the assessment of alternative means of compliance used by the competent authority itself;
• (9) findings, corrective actions and date of action closure;
• (10) enforcement measures taken;
• (11) safety information and follow-up measures;
• (12) the use of flexibility provisions in accordance with Article 71 of Regulation (EU) 2018/1139; and
• (13) the evaluation and authorisation process of aircraft laid down in points ORA.ATO.135 (a) and DTO.GEN.240 (a).

• (b) The competent authority shall establish and keep up to date a list of all organisation certificates, FSTD qualification certificates and personnel licences, certificates and attestations it issued, DTO declarations it received, and the DTO training programmes it verified or approved for compliance with Annex I (Part-FCL), Annex III (Part-BFCL) to Commission Regulation (EU) 2018/395, or Annex III (Part-SFCL) to Commission Implementing Regulation (EU) 2018/1976.

- (c) All records shall be kept for the minimum period specified in this Regulation. In the absence of such indication, records shall be kept for a minimum period of 5 years subject to applicable data protection law.

SECTION III

Oversight, certification and enforcement

ARA.GEN.300   Oversight

- (a) The competent authority shall verify:

• (1) compliance with the requirements applicable to organisations or persons prior to the issue of an organisation certificate, approval, FSTD qualification certificate or personnel licence, certificate, rating, or attestation, as applicable;
• (2) continued compliance with the requirements applicable to the persons holding licences, ratings and certificates, the organisations it has certified, the holders of a FSTD qualification and the organisations from which it received a declaration;
• (3) implementation of appropriate safety measures mandated by the competent authority as defined in ARA.GEN.135(c) and (d).

• (b) This verification shall:
• (1) be supported by documentation specifically intended to provide personnel responsible for safety oversight with guidance to perform their functions;
• (2) provide the persons and organisations concerned with the results of safety oversight activity;
• (3) be based on audits and inspections, including ramp and unannounced inspections; and
• (4) provide the competent authority with the evidence needed in case further action is required, including the measures foreseen by ARA.GEN.350 and ARA.GEN.355.

• (c) The scope of oversight defined in (a) and (b) shall take into account the results of past oversight activities and the safety priorities.

• (d) Without prejudice to the competences of the Member States and to their obligations as set out in ARO.RAMP, the scope of the oversight of activities performed in the territory of a Member State by persons or organisations established or residing in another Member State shall be determined on the basis of the safety priorities, as well as of past oversight activities.

- (e) Where the activity of a person or organisation involves more than one Member State or the Agency, the competent authority responsible for the oversight under (a) may agree to have oversight tasks performed by the competent authority(ies) of the Member State(s) where the activity takes place or by the Agency. Any person or organisation subject to such agreement shall be informed of its existence and of its scope.

• (f) The competent authority shall collect and process any information deemed useful for oversight, including for ramp and unannounced inspections.

• (g) With regard to the certification and oversight of the organisation’s compliance with point ORA.GEN.200A of this Annex, in addition to complying with points (a) to (f) of this point, the competent authority shall review any approval granted under point IS.I.OR.200(e) of Annex II to Commission Implementing Regulation (EU) 2023/203 ([^E0023]) following the applicable oversight audit cycle and whenever changes are implemented in the scope of work of the organisation.

ARA.GEN.305   Oversight programme

• (a) The competent authority shall establish and maintain an oversight programme covering the oversight activities required by ARA.GEN.300 and by ARO.RAMP.

- (b) For organisations certified by the competent authority and FSTD qualification certificate holders, the oversight programme shall be developed taking into account the specific nature of the organisation, the complexity of its activities, the results of past certification and/or oversight activities and shall be based on the assessment of associated risks. It shall include within each oversight planning cycle:

• (1) audits and inspections, including ramp and unannounced inspections as appropriate; and
• (2) meetings convened between the accountable manager and the competent authority to ensure both remain informed of significant issues.

• (c) For organisations certified by the competent authority and FSTD qualification certificate holders an oversight planning cycle not exceeding 24 months shall be applied. The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation or the FTSD qualification certificate holder has decreased. The oversight planning cycle may be extended to a maximum of 36 months if the competent authority has established that, during the previous 24 months:
• (1) the organisation has demonstrated an effective identification of aviation safety hazards and management of associated risks;
• (2) the organisation has continuously demonstrated under ORA.GEN.130 that it has full control over all changes;
• (3) no level 1 findings have been issued; and
• (4) all corrective actions have been implemented within the time period accepted or extended by the competent authority as defined in ARA.GEN.350(d)(2). The oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the above, the organisation has established, and the competent authority has approved, an effective continuous reporting system to the competent authority on the safety performance and regulatory compliance of the organisation itself.

- (ca) Notwithstanding (c), for organisations only providing training towards the LAPL, PPL, SPL or BPL and associated ratings and certificates, an oversight planning cycle not exceeding 48 months shall be applied. The oversight planning cycle shall be reduced if there is evidence that the safety performance of the organisation holder has decreased.

The oversight planning cycle may be extended to a maximum of 72 months, if the competent authority has established that, during the previous 48 months: - (1) the organisation has demonstrated an effective identification of aviation safety hazards and management of associated risks, as demonstrated by the results of the annual review in accordance with ORA.GEN.200(c); - (2) the organisation has continuously maintained control over all changes in accordance with ORA.GEN.130 as demonstrated by the results of the annual review in accordance with ORA.GEN.200(c); - (3) no level 1 findings have been issued; and - (4) all corrective actions have been implemented within the time period accepted or extended by the competent authority as defined in ARA.GEN.350(d)(2).

- (d) For persons that hold a licence, certificate, rating, or attestation issued by the competent authority, the oversight programme shall include an appropriate volume of inspections and unannounced inspections.

- (e) The oversight programme shall include records of the dates when audits, inspections and meetings are due and when such audits, inspections and meetings have been carried out.

- (f) Notwithstanding points (b), (c), and (ca), the oversight programme of DTOs shall be developed taking into account the specific nature of the organisation, the complexity of its activities and the results of past oversight activities and shall be based on the assessment of risks associated with the type of training provided. The oversight activities shall include inspections, including unannounced inspections, and may, as deemed necessary by the competent authority, include audits.

ARA.GEN.310   Initial certification procedure – organisations

• (a) Upon receiving an application for the initial issue of a certificate for an organisation, the competent authority shall verify the organisation’s compliance with the applicable requirements.

- (b) When satisfied that the organisation is in compliance with the applicable requirements, the competent authority shall issue the certificate(s), as established in Appendixes III and V to this Part. The certificate(s) shall be issued for an unlimited duration. The privileges and scope of the activities that the organisation is approved to conduct shall be specified in the terms of approval attached to the certificate(s).

• (c) To enable an organisation to implement changes without prior competent authority approval in accordance with ORA.GEN.130, the competent authority shall approve the procedure submitted by the organisation defining the scope of such changes and describing how such changes will be managed and notified.

ARA.GEN.315   Procedure for issue, revalidation, renewal or change of licences, ratings, certificates or attestations – persons

• (a) Upon receiving an application for the issue, revalidation, renewal or change of a personal licence, rating, certificate or attestation and any supporting documentation, the competent authority shall verify whether the applicant meets the applicable requirements.

• (b) When satisfied that the applicant meets the applicable requirements, the competent authority shall issue, revalidate, renew or change the licence, certificate, rating, or attestation.

ARA.GEN.330   Changes – organisations

- (a) Upon receiving an application for a change that requires prior approval, the competent authority shall verify the organisation’s compliance with the applicable requirements before issuing the approval.

The competent authority shall prescribe the conditions under which the organisation may operate during the change, unless the competent authority determines that the organisation’s certificate needs to be suspended. When satisfied that the organisation is in compliance with the applicable requirements, the competent authority shall approve the change.

- (b) Without prejudice to any additional enforcement measures, when the organisation implements changes requiring prior approval without having received competent authority approval as defined in (a), the competent authority shall suspend, limit or revoke the organisation’s certificate.

- (c) For changes not requiring prior approval, the competent authority shall assess the information provided in the notification sent by the organisation in accordance with ORA.GEN.130 to verify compliance with the applicable requirements. In case of any non-compliance, the competent authority shall:

• (1) notify the organisation about the non-compliance and request further changes; and
• (2) in case of level 1 or level 2 findings, act in accordance with ARA.GEN.350.

- (d) Notwithstanding points (a), (b) and (c), in the case of changes to the information contained in the declarations received from a DTO or to the training programme used by the DTO, notified to it in accordance with point DTO.GEN.116 of Annex VIII (Part-DTO), the competent authority shall act in accordance with the requirements of points ARA.DTO.105 and ARA.DTO.110, as applicable.

ARA.GEN.330A   Changes to the information security management system

• (a) With regard to changes managed and notified to the competent authority in accordance with the procedure set out in point IS.I.OR.255(a) of Annex II (Part-IS.I.OR) to Implementing Regulation (EU) 2023/203, the competent authority shall include the review of such changes in its continuing oversight in accordance with the principles laid down in point ARA.GEN.300. If any non-compliance is found, the competent authority shall notify the organisation thereof, request further changes and act in accordance with point ARA.GEN.350.

• (b) With regard to other changes requiring an application for approval in accordance with point IS.I.OR.255(b) of Annex II (Part-IS.I.OR) to Implementing Regulation (EU) 2023/203:
• (1) upon receiving the application for the change, the competent authority shall check the organisation’s compliance with the applicable requirements before issuing the approval;
• (2) the competent authority shall establish the conditions under which the organisation may operate during the implementation of the change;
• (3) if it is satisfied that the organisation complies with the applicable requirements, the competent authority shall approve the change.

ARA.GEN.350   Findings and corrective actions – organisations

- (a) The competent authority for oversight in accordance with ARA.GEN.300 (a) shall have a system to analyse findings for their safety significance.

• (b) A level 1 finding shall be issued by the competent authority when any significant non-compliance is detected with the applicable requirements of Regulation (EC) No 216/2008 and its Implementing Rules, with the organisation’s procedures and manuals or with the terms of an approval or certificate which lowers safety or seriously hazards flight safety. The level 1 findings shall include:
• (1) failure to give the competent authority access to the organisation’s facilities as defined in ORA.GEN.140 during normal operating hours and after two written requests;
• (2) obtaining or maintaining the validity of the organisation certificate by falsification of submitted documentary evidence;
• (3) evidence of malpractice or fraudulent use of the organisation certificate; and
• (4) the lack of an accountable manager.

• (c) A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EC) No 216/2008 and its Implementing Rules, with the organisation’s procedures and manuals or with the terms of an approval or certificate which could lower safety or hazard flight safety.

• (d) When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EC) No 216/2008 and its Implementing Rules, communicate the finding to the organisation in writing and request corrective action to address the non-compliance(s) identified. Where relevant, the competent authority shall inform the State in which the aircraft is registered.
• (1) In the case of level 1 findings the competent authority shall take immediate and appropriate action to prohibit or limit activities and, if appropriate, it shall take action to revoke the certificate or specific approval or to limit or suspend it in whole or in part, depending upon the extent of the level 1 finding, until successful corrective action has been taken by the organisation.
• (2) In the case of level 2 findings, the competent authority shall:
• (i) grant the organisation a corrective action implementation period appropriate to the nature of the finding that in any case initially shall not be more than 3 months. At the end of this period, and subject to the nature of the finding, the competent authority may extend the 3-month period subject to a satisfactory corrective action plan agreed by the competent authority; and
• (ii) assess the corrective action and implementation plan proposed by the organisation and, if the assessment concludes that they are sufficient to address the non-compliance(s), accept these.
• (3) Where an organisation fails to submit an acceptable corrective action plan, or to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to a level 1 finding and action taken as laid down in (d)(1).
• (4) The competent authority shall record all findings it has raised or that have been communicated to it and, where applicable, the enforcement measures it has applied, as well as all corrective actions and date of action closure for findings.

• (da) By way of derogation from paragraphs (a) to (d), in the case of DTOs, if during oversight or by any other means the competent authority finds evidence that indicates DTO non-compliance with the essential requirements set out in Annex IV to Regulation (EU) 2018/1139, with the requirements of Annex I (Part-FCL) and Annex VIII (Part-DTO) to this Regulation, or with the requirements of Annex III (Part-BFCL) to Commission Regulation (EU) 2018/395 and of Annex III (Part-SFCL) to Commission Implementing Regulation (EU) 2018/1976, the competent authority shall:
• (1) raise a finding, record it, communicate it in writing to the representative of the DTO and determine a reasonable period of time within which the DTO is to take the steps specified in point DTO.GEN.150 of Annex VIII (Part-DTO);
• (2) take immediate and appropriate action to limit or prohibit the training activities affected by the non-compliance until the DTO has taken the corrective action referred to in point (1), where any of the following situations occurs:
• (i) a safety problem has been identified;
• (ii) the DTO fails to take corrective action in accordance with point DTO.GEN.150;
• (3) in respect of the training programmes referred to in point DTO.GEN.230(c) of Annex VIII (Part-DTO), limit, suspend or revoke the approval of the training programme;
• (4) take any further enforcement measures necessary in order to ensure the termination of the non-compliance and, where relevant, remedy the consequences thereof.

• (e) Without prejudice to any additional enforcement measures, if the authority of a Member State that acts in accordance with point ARA.GEN.300(d) identifies any non-compliance with the essential requirements set out in Annex IV to Regulation (EU) 2018/1139, with the requirements of Annex I (Part-FCL), Annex VII (Part-ORA) and Annex VIII (Part-DTO) to this Regulation, or with the requirements of Annex III (Part-BFCL) to Commission Regulation (EU) 2018/395 and of Annex III (Part-SFCL) to Commission Implementing Regulation (EU) 2018/1976 by an organisation certified by, or having made a declaration to, the competent authority of another Member State or the Agency, it shall inform that competent authority of that non-compliance.