PART 21

Certification of aircraft and related products, parts and appliances, and of design and production organisations

GM1 Annex I Definitions

ED Decision 2022/021/R

For the purpose of the Acceptable Means of Compliance (AMC) and Guidance Material (GM) to Annex I (Part 21) to Regulation (EU) No 748/2012, the following definitions apply:

Audit

It refers to a systematic, independent, and documented process for obtaining evidence and objectively evaluating it to determine the extent to which the requirements are complied with.

Note: audits may include inspections.

Assessment

In the context of management system performance monitoring, continuous improvement, and oversight, it refers to a planned and documented activity that is performed by competent personnel to evaluate and analyse the achieved level of performance and maturity in relation to the organisation’s policy and objectives.

Note: an assessment focuses on desirable outcomes and the overall performance, looking at the organisation as a whole. The main objective of the assessment is to identify the strengths and weaknesses to drive continual improvement.

Remark: for ‘risk assessment’, please refer to the definition below.

Certificate

It is any certificate, approval, licence, authorisation, attestation or other document that is issued as the outcome of the certification process, which attests compliance with the applicable requirements.

Competency

It is a combination of individual skills, practical and theoretical knowledge, attitude, training, and experience.

Correction

It is the action to eliminate detected non-compliance.

Corrective action

It is the action to eliminate or mitigate the root cause(s) and prevent the recurrence of existing detected non-compliance, or of any other undesirable condition or situation. Proper determination of the root cause(s) is crucial for defining effective corrective action to prevent reoccurrence.

Error

It is a person’s action or inaction that may lead to deviations from the accepted procedures or regulations.

Note: errors are often associated with occasions when a planned sequence of mental or physical activities either fails to achieve its intended outcome, or is not appropriate with regard to the intended outcome, and when results cannot be attributed purely to chance.

Fatigue

It is a physiological state of reduced mental or physical performance capability, resulting from sleep loss or extended wakefulness, circadian phase, or workload (mental and/or physical activity), which can impair a person’s alertness and ability to safely perform their tasks.

Hazard

It is a condition or an object with the potential to cause, or contribute to, an aircraft incident or accident.

Human factors (HF)

It is anything that affects human performance, which means principles that apply to aeronautical activities, and which seek safe interface between the human and other system components by proper consideration of human performance (ref. ICAO Doc 10151 — Human Performance (HP) Manual for Regulators6 ICAO Document 10151 ‘Manual on Human Performance (HP) for Regulators’, First Edition, 2021.).

Human performance (HP)

It refers to human capabilities and limitations that have an impact on the safety and efficiency of aeronautical activities (ref. ICAO Doc 10151 — Human Performance (HP) Manual for Regulators7 Ibid.).

Inspection

In the context of compliance monitoring and oversight, it refers to an independent and documented conformity evaluation by observation and judgement, which is accompanied, as appropriate, by measurements, testing or gauging, in order to verify compliance with the applicable requirements.

Note: inspection may be part of an audit (e.g. product audit), but may also be conducted outside the normal audit plan; for example, to verify the closure of a particular finding.

‘Just culture’

Ref. Article 2 of Regulation (EU) No 376/20148.

Near miss

It is an event in which an occurrence to be mandatorily reported according to Regulation (EU) No 376/2014 was narrowly averted or avoided.

Example: a staff member, on rechecking their work at the end of a task, realises that one work card step was not properly carried out.

Organisational factor

It is a condition that affects the effectiveness of safety risk controls, and is related to the culture, policies, processes, resources, and the workplace of an organisation.

Oversight planning cycle

It refers to the time frame within which the areas of the approval and the processes that are identified through a risk assessment should be reviewed by the competent authority by means of audits and inspections.

Oversight programme

It refers to the detailed oversight schedule that defines the number of audits and other activities, including the scope and duration of each activity, as well as the details of product audits and locations, as appropriate, to be performed by the competent authority, and to the tentative time frame for performing each activity.

Preventive action

It is the action to eliminate the cause of potential non-compliance, or any other undesirable potential situation.

Risk assessment

It is an evaluation that is based on engineering and operational judgement and/or analysis methods in order to establish whether the achieved or perceived risk is acceptable or tolerable.

Safety culture

It is an enduring set of values, norms, attitudes, and practices within an organisation, which is concerned with minimising the exposure of the workforce and the general public to dangerous or hazardous conditions. In a positive safety culture, a shared concern for, commitment to, and accountability for, safety is promoted.

Safety risk

It refers to the predicted probability and severity of the consequences or outcomes of a hazard.

Safety training

It refers to dedicated training to support safety management policies and processes, including HF training.

Note 1: the main objective of the safety training programme is to ensure that personnel at all levels of the organisation maintain their competency to fulfil their roles safely. Safety training should, in particular, consider the safety knowledge that is derived from hazard identification and risk management processes, and forster a positive safety culture.

Note 2: safety management training refers to specific training for the staff that are involved in safety management functions in accordance with points 21.A.139(c) and 21.A.239(c) of Part 21.

Working days

It refers to days between, and including, Monday and Friday, except public holidays.

GM2 Annex I Abbreviations

ED Decision 2022/021/R

For the purpose of the AMC and GM to Part 21, the following abbreviations apply:

AFM

Aircraft flight manual

AMC

Acceptable means of compliance

APU

Auxiliary power unit

CEO

Chief executive officer

CMR

Certification maintenance requirement

CofA

Certificate of airworthiness

CRI

Certification review item

CS

Certification specification

CS-CCD

Certification Specifications for Cabin Crew Data

CS-FCD

Certification Specifications for Operational Suitability Data (OSD) Flight Crew Data

CS-GEN-MMEL

Certification Specifications for Generic Master Minimum Equipment List

CS-MMEL

Certification Specifications for Master Minimum Equipment List

CS-MCSD

Certification Specifications for Maintenance Certifying Staff Data

CS-SIMD

Certification Specifications for Simulator Data

DAH

Design approval holder

DO

Design organisation

DOA

Design organisation approval

EDTO

Extended diversion time operation

ELOS

Equivalent level of safety

ESF

Equivalent safety finding

ETSO

European technical standard order

FOD

Foreign object damage

HDO

Head of the design organisation

ICAO

International Civil Aviation Organization

ICA

Instructions for continued airworthiness

OP

Other party

OSD

Operational suitability data

PAH

Production approval holder

PO

Production organisation

POA

Production organisation approval

POATL

Production organisation approval team leader

POE

Production organisation exposition

GM

Guidance material

MoC

Means of compliance

RCofA

Restricted certificate of airworthiness

RTC

Restricted type certificate

SC

Special condition

SMS

Safety management system

STC

Supplemental type certificate

TC

Type certificate

TCDS

Type certificate data sheet

21.1. Competent authority

Regulation (EU) 2022/203

For the purpose of this Annex, the ‘competent authority’ shall be:

(a) for Section A, Subpart A,

1. for design organisations, the Agency;

2. for production organisations that have their principal place of business in a territory for which a Member State is responsible under the Convention on International Civil Aviation, signed in Chicago on 7 December 1944 (‘the Chicago Convention’), the authority designated by that Member State or by another Member State in accordance with Article 64 of Regulation (EU) 2018/1139, or the Agency if the responsibility has been reallocated to the Agency in accordance with Article 64 or 65 of Regulation (EU) 2018/1139;

3. for production organisations that have their principal place of business outside a territory for which a Member State is responsible under the Chicago Convention, the Agency;

(b) for Section A, Subparts B, D, E, J, K, M, O and Q, the Agency;

(c) for Section A, Subparts F and G:

1. for natural or legal persons that have their principal place of business in a territory for which a Member State is responsible under the Chicago Convention, the authority designated by that Member State or by another Member State in accordance with Article 64 of Regulation (EU) 2018/1139, or the Agency if the responsibility has been reallocated to the Agency in accordance with Article 64 or, as regards Subpart G, Article 65 of Regulation (EU) 2018/1139;

2. for natural or legal persons that have their principal place of business outside a territory for which a Member State is responsible under the Chicago Convention, the Agency;

(d) for Section A, Subpart H and I, the authority designated by the Member State where the aircraft is registered or will be registered:

(e) for Section A, Subpart P:

1. for aircraft registered in a Member State, the authority designated by the Member State of registry;

2. for unregistered aircraft, the authority designated by the Member State which prescribed the identification marks;

3. for the approval of the flight conditions related to the safety of the design, the Agency.

GM1 21.1 Competent authority

ED Decision 2022/021/R

RESPONSIBILITY FOR THE IMPLEMENTATION OF PART 21

Each certificate or approval in accordance with Part 21, Section A, Subparts F, G, H, I, and P is normally issued and overseen by the competent authority of the Member State in which the applicant or holder is located. Therefore, to ensure consistency between the competent authorities of the Member States in issuing certificates and approvals, the implementation of Part 21 should be based on the following three principles:

(a) the establishment and maintenance of an effective organisation and of the corresponding processes by the competent authorities;

(b) the operation of the competent authorities in accordance with Part 21 and the AMC and GM thereto; and

(c) a standardisation process that is established and applied by EASA to assess the standard(s) achieved, and to provide timely advice and guidance to the competent authorities.

As a result, the responsibility for implementation of Part 21 has two main objectives:

(a) to ensure that certificates and approvals are only granted to applicants that comply with the requirements of Part 21; and

(b) to ensure that there is sufficient visibility of the processes, to give EASA and the Member States the necessary confidence in the certificates or approvals granted.

GM1 21.1(e) Competent authority

ED Decision 2022/021/R

PERMIT TO FLY

An aircraft that is registered in a Member State is under the responsibility of that Member State regarding continuing-airworthiness aspects. Consequently, permits to fly under Part 21 may be issued by that Member State, including for cases in which the aircraft flies in another State. The permit to fly contains all the conditions and restrictions to ensure safe flight, but other airspace and operational rules remain within the competence of the authority of the State where the flight takes place, and may apply. Therefore, the applicant is also required to ensure compliance with the applicable rules of that State.

21.2 Scope

Regulation (EU) 2022/203

Section A of this Annex establishes the provisions that lay down the rights and obligations of the applicant for, and holder of, any certificate issued or to be issued in accordance with this Annex.

Section B of this Annex establishes the conditions for conducting the certification oversight and enforcement tasks as well as the administrative and management system requirements to be complied with by the competent authority that is responsible for the implementation of Section A of this Annex.