We find the best solution for you
During our consulting we work out the best solution together with you, so that you can work with the new / improved system later. Our consulting management covers, among other things, the development and implementation of quality systems:
Part 21, Subpart J (DOA)
QUALITY AND SAFETY REQUIRE TRANSPARENT AND REPETITIVE PROCESSES.
The way to a certified (approved) aeronautical product (aircraft, engine, propeller) or to a modification of already certified (approved) products.
1.) WHY IS A DESIGN ORGANIZATION NEEDED?
Anyone intending to develop products (aircraft, engines, propellers) or modifications to products and associated parts and equipment (such as structural elements, landing gear, avionics and other parts) or ETSO articles in accordance with the applicable design standards (CS - Certification Specification) requires approval as a design organisation in accordance with (EU)748/2012, Part 21, Subpart J (DOA).
This means that an legal entity or natural person (applicant) has demonstrated compliance with the applicable certification specifications (design standards for each aircraft category, environmental requirements, operational suitability data, and special conditions, if applicable) in accordance with the requirements of the applicable sections of EASA Part 21, Subpart J and other Subparts, e.g., A; B; D; E; K; P; and Q.
As evidence of compliance with the type-certification basis, the following certificates may be issued after certification:
However, if the product (aircraft, engine, propeller) or the modification to an already approved product is more complex and/or new, the requirements for the Design Management System (DMS) will be higher.
Notice. Please note that a Design Organization under Alternate Procedures (ADOA. Limited Design Activities Only.) must meet a simplified requirement per 21.A.14.
2.) OPTIONS FOR MEETING THE REQUIREMENTS OF PART 21 (DOA)
The following requirements may be met to demonstrate the organization's eligibility for the desired approval for a particular design:
The way to a certified (approved) aeronautical product (aircraft, engine, propeller) or to a modification of already certified (approved) products.
1.) WHY IS A DESIGN ORGANIZATION NEEDED?
Anyone intending to develop products (aircraft, engines, propellers) or modifications to products and associated parts and equipment (such as structural elements, landing gear, avionics and other parts) or ETSO articles in accordance with the applicable design standards (CS - Certification Specification) requires approval as a design organisation in accordance with (EU)748/2012, Part 21, Subpart J (DOA).
This means that an legal entity or natural person (applicant) has demonstrated compliance with the applicable certification specifications (design standards for each aircraft category, environmental requirements, operational suitability data, and special conditions, if applicable) in accordance with the requirements of the applicable sections of EASA Part 21, Subpart J and other Subparts, e.g., A; B; D; E; K; P; and Q.
As evidence of compliance with the type-certification basis, the following certificates may be issued after certification:
- Declaration of Compliance or
- DDP (Declaration of Design and Performance. For ETSO articles only).
However, if the product (aircraft, engine, propeller) or the modification to an already approved product is more complex and/or new, the requirements for the Design Management System (DMS) will be higher.
Notice. Please note that a Design Organization under Alternate Procedures (ADOA. Limited Design Activities Only.) must meet a simplified requirement per 21.A.14.
2.) OPTIONS FOR MEETING THE REQUIREMENTS OF PART 21 (DOA)
The following requirements may be met to demonstrate the organization's eligibility for the desired approval for a particular design:
* For definitions see (EU) 748/2012 Article 1
** For definitions see GM 21.A.112B
*** Upon Agency agreement
Quelle: EASA
3.) DESIGN MANAGEMENT SYSTEM (DMS)
The DMS is a system for controlling and monitoring the design, design changes to products and parts that fall under the conditions of approval.
A component of the DMS is the Safety Management System (SMS). The objective of the SMS is to identify and assess hazards to product, its modification or design organization in terms of aviation safety and to manage the associated risks, including risk mitigation measures, and to verify their effectiveness.
In short, the established technical organizational and personnel requirements must cover the EASA Part 21 Subpart J requirements.
The DMS must control all external organizations (such as design subcontractors) involved in design activities.
The DMS is based on two pillars:
** For definitions see GM 21.A.112B
*** Upon Agency agreement
Quelle: EASA
3.) DESIGN MANAGEMENT SYSTEM (DMS)
The DMS is a system for controlling and monitoring the design, design changes to products and parts that fall under the conditions of approval.
A component of the DMS is the Safety Management System (SMS). The objective of the SMS is to identify and assess hazards to product, its modification or design organization in terms of aviation safety and to manage the associated risks, including risk mitigation measures, and to verify their effectiveness.
In short, the established technical organizational and personnel requirements must cover the EASA Part 21 Subpart J requirements.
The DMS must control all external organizations (such as design subcontractors) involved in design activities.
The DMS is based on two pillars:
- Design related: Independent design review ("4-eyes principle") by CVE (Compliance Verification Engineer).
- DMS related: Independent System Monitoring Function (ISM)
4.) THE PATH TO BECOMING AN APPROVED DESIGN ORGANIZATION (DOA)
To establish a Design Organization (DO) under EASA Part 21 Subpart J, you will need:
- Provide technical, organizational, and personnel requirements in accordance with EASA Part 21 Subpart J,
- Design Manual (DOH) describing the DMS considering the relevant requirements of EASA Part 21 Subpart J, A, B, E, D, K, P and Q,
- Flight Test Operations Manual (FTOM), only for design organizations that are developing new products or modifying existing products and need to perform test flights.
5.) ACC SERVICES IN THE AREA OF PART 21, SECTION J (DOA)
We assist our customers in establishing Part 21, Subpart J and attainment of authorization (DOA) development operations, including:
- developing or providing high-quality generic design organization manuals tailored to your organization and type of development activities,
- Developing or providing high-quality flight test operation manuals (FTOMs),
- Training and coaching of personnel,
- Gap analysis (implemented design system vs. requirements of EASA Part 21, Sections J, A, B, E, D, K, P, and Q,
- Conduct internal audits, including pre-approval audits prior to official EASA approval audits in Phase 3 (prior to 3rd checkpoint),
- Interim management for ISM function,
- Support of EASA audits and meetings.
Part 21, Subpart G (POA)
QUALITY AND SAFETY REQUIRE TRANSPARENT AND REPETITIVE PROCESSES.
Safe processes / procedures produce safe products!
1.) WHY APPROVED PRODUCTION ORGANISATION (POA)?
Anyone (legal entity or natural person) who manufactures products (aircraft, engines, propellers) or parts of construction and equipment, including ETSO articles, in accordance with approved design documents, requires an official permit as a production organization (POA).
The POA holder may perform the following activities within its privileges:
2.) THE PATH TO THE APPROVED PRODUCTION ORGANISATION (POA)
The basic requirement for establishing a approved production organization (POA) is the existence of what is known as a design organization-production organization (DO-PO) agreement under 21.A.133(c).
In short. The type certificate holder, e.g., an approved design organisation, assumes responsibility and must transfer all applicable design documents to the manufacturing organisation and agree on certain interface procedures that must be followed by both organisations (e.g., production document preparation of manufacturing data or management of production deviations).
The system of the manufacturing plant can be integrated into the existing management systems according to DIN EN ISO 9001 or EN 9100.
3.) OBLIGATIONS OF AN APPROVED PRODUCTION ORGANISATION (POA) ACC. PART 21, SUBPART G
To ensure that the product or a part and appliance conforms to the applicable design data (AS BUILT, AS DESIGNED) under the Production Management System (PMS):
4.) WHAT IS NEEDED TO OBTAIN A PRODUCTION ORGANISATION APPROVAL
(POA)
If the requirements for approval (such as the DO-PO agreement) are in place, the following issues should be addressed:
For new products (aircraft; helicopters; balloons; engines; propellers):
5.) ACC SERVICES IN THE AREA OF PART 21, SUBPART G (POA)
Consulting services for the establishment of manufacturing operations according to Part 21, Subpart G (POA), incl.:
For General Aviation operations (ELA 1 and ELA 2 aircraft), we are happy to incorporate AMC ELA into concepts, project plans, manuals, and procedures.
Safe processes / procedures produce safe products!
1.) WHY APPROVED PRODUCTION ORGANISATION (POA)?
Anyone (legal entity or natural person) who manufactures products (aircraft, engines, propellers) or parts of construction and equipment, including ETSO articles, in accordance with approved design documents, requires an official permit as a production organization (POA).
The POA holder may perform the following activities within its privileges:
- Manufacture aircraft, parts, and appliances, and ETSO articles in accordance with the approved scope and capability list (Capabillity list),
- Issue certificates of conformity and release to service under its privileges for aircraft, parts, and appliances, and ETSO articles after the finishing of manufacturing.
2.) THE PATH TO THE APPROVED PRODUCTION ORGANISATION (POA)
The basic requirement for establishing a approved production organization (POA) is the existence of what is known as a design organization-production organization (DO-PO) agreement under 21.A.133(c).
In short. The type certificate holder, e.g., an approved design organisation, assumes responsibility and must transfer all applicable design documents to the manufacturing organisation and agree on certain interface procedures that must be followed by both organisations (e.g., production document preparation of manufacturing data or management of production deviations).
The system of the manufacturing plant can be integrated into the existing management systems according to DIN EN ISO 9001 or EN 9100.
3.) OBLIGATIONS OF AN APPROVED PRODUCTION ORGANISATION (POA) ACC. PART 21, SUBPART G
To ensure that the product or a part and appliance conforms to the applicable design data (AS BUILT, AS DESIGNED) under the Production Management System (PMS):
- Issue of Certificate of Conformity EASA Form 52 for new aircraft for which a type certificate has been issued,
- Issue of Certificate of Release to Service EASA Form 53 for aircraft requiring pre-delivery maintenance,
- Approval of flight conditions EASA Form 18b and issue of permit to fly EASA Form 20,
- Issue of Certificate of Conformity/Release EASA Form 1 "NEW" for parts and appliances according to approved design data,
- Issue of Certificate of Conformity EASA Form 1 "PROTOTYPE" according to non-approved applicable design data (e.g., test specimen).
4.) WHAT IS NEEDED TO OBTAIN A PRODUCTION ORGANISATION APPROVAL
(POA)
If the requirements for approval (such as the DO-PO agreement) are in place, the following issues should be addressed:
For new products (aircraft; helicopters; balloons; engines; propellers):
- Establishment of a Production Management System (PMS) in accordance with 21.A.139 including Production Organization Manual (POH, POE, QMH), and,
- Flight Test Operations Manual - FTOM (for complete aircraft only),
- Provide resources (technical, organizational and personnel) in accordance with 21.A.145 to meet the requirements of Part 21, Subpart G (21.A.165 "Responsibilities of the holder"),
- Safety Management System (SMS) requirements must be considered and implemented when establishing the Production Management System (PMS).
5.) ACC SERVICES IN THE AREA OF PART 21, SUBPART G (POA)
Consulting services for the establishment of manufacturing operations according to Part 21, Subpart G (POA), incl.:
- Preparation of concepts and plans for establishing manufacturing operations while meeting approval requirements under Part 21, Subpart G,
- Determination of the degree of compliance (gap analyses) between existing procedures (e.g., according to ISO 9001, EN 9100 and others) and Part 21, Subpart G and other co-applicable Subparts,
- Support the development of project management plans and work packages with focus according to the gap analysis, considering internal capacities and resources,
- Delivery and adapting of high-quality generic manufacturing operation manuals / quality management manuals (POH / POE / QMH), procedures and forms (German or English),
- Delivery and adapting of high quality FTOMs (Flight Test Operations Manuals),
- Delivery of Compliance Checklists (CCL) for the entire system,
- Conducting internal and external audits,
- Interim Management around Quality Management (QM),
- Consulting for more efficient implementation of Part 21 Subpart G requirements, process, and procedure optimization,
- introduction of safety management systems (SMS),
- Training concepts customized to the scope of approval (human factors, SMS Part 21 Subpart G, air law, determination of conformity for certifying staff, materials management, and supplier management, etc.),
- Project-related coaching of employees / teams (quality managers, operations managers, certifying staff, buyers, work planners, project managers, etc.).
For General Aviation operations (ELA 1 and ELA 2 aircraft), we are happy to incorporate AMC ELA into concepts, project plans, manuals, and procedures.
Part 145 (MOA)
QUALITY AND SAFETY REQUIRE TRANSPARENT AND REPETITIVE PROCESSES.
1.) SYSTEM REQUIREMENTS FOR THE APPROVED MAINTENANCE ORGANIZATION (MOA - MAINTENANCE ORGANIZATION APPROVAL)
Anyone maintaining certified products (aircraft, engines, propellers) or parts and appliances and ETSO items in accordance with the approved Instructions for Continuing Airworthiness (ICA) requires regulatory approval.
Mandatory approval standard:
(EU) 1321 / 2014, Part 145 (for commercially and privately operated aircraft and their components).
The approval as a maintenance organization covers only the so-called scope of work (SoW - Scope of Work: complete aircraft and/or parts and appliances).
2.) MAIN TASKS OF AN APPROVED MAINTENANCE ORGANISATION
The main task of the approved maintenance organisation is:
2.1. PREREQUISITES FOR APPROVAL AS A MAINTENANCE ORGANIZATION
Important prerequisites for the approval activities on the part of the competent authority and the application (EASA Form 2) are:
*Design Approval Holder
3.) PART 145 REQUIRES A QUALITY MANAGEMENT SYSTEM (QMS)
For effective and transparent control of processes and procedures, a quality management system (QMS) shall be established and described in a maintenance operation manual (MOE / MOH -Maintenance Organization Exposition / Maintenance Organization Manual) (145.A.70).
3.1. IMPORTANT SYSTEM AND PRODUCT RELEVANT PROCEDURES
Approved Maintenance Organization (MOA) procedures must address the following requirements, among others:
3.2. PRIVILEGES
Privileges of an approved maintenance organization (MOA) may include:
4.) ACC SERVICES IN THE AREA OF PART 145
4.1. CONSULTATION
4.2. PRODUCTS
1.) SYSTEM REQUIREMENTS FOR THE APPROVED MAINTENANCE ORGANIZATION (MOA - MAINTENANCE ORGANIZATION APPROVAL)
Anyone maintaining certified products (aircraft, engines, propellers) or parts and appliances and ETSO items in accordance with the approved Instructions for Continuing Airworthiness (ICA) requires regulatory approval.
Mandatory approval standard:
(EU) 1321 / 2014, Part 145 (for commercially and privately operated aircraft and their components).
The approval as a maintenance organization covers only the so-called scope of work (SoW - Scope of Work: complete aircraft and/or parts and appliances).
2.) MAIN TASKS OF AN APPROVED MAINTENANCE ORGANISATION
The main task of the approved maintenance organisation is:
- Ensure that contracted maintenance is performed and released in accordance with Part 145 and approved instructions for continued airworthiness.
2.1. PREREQUISITES FOR APPROVAL AS A MAINTENANCE ORGANIZATION
Important prerequisites for the approval activities on the part of the competent authority and the application (EASA Form 2) are:
- Existence of technical, organizational, and personnel requirements to be met for the assigned scope of work, i.e., for example:
- Existence of qualified Certifying Staff to release aircraft or parts and appliances for operation after maintenance,
- Existence of exact job planning considering requirements from instructions for continued airworthiness (AMM, CRM, CMM, SRM, etc.),
- Availability of a safety manager function,
- Existence of current instructions for continued airworthiness (AMM, CRM, CMM, SRM, etc.),
- Existence of suitable locations, tools, and other equipment to perform maintenance in accordance with regulatory and DAH* requirements.
*Design Approval Holder
3.) PART 145 REQUIRES A QUALITY MANAGEMENT SYSTEM (QMS)
For effective and transparent control of processes and procedures, a quality management system (QMS) shall be established and described in a maintenance operation manual (MOE / MOH -Maintenance Organization Exposition / Maintenance Organization Manual) (145.A.70).
3.1. IMPORTANT SYSTEM AND PRODUCT RELEVANT PROCEDURES
Approved Maintenance Organization (MOA) procedures must address the following requirements, among others:
- resource-based maintenance order planning,
- Qualification of employees and certifying staff,
- Selection and monitoring of external suppliers (Supplier Management),
- Incident Management (Occurrence Reporting),
- Safety Management,
- Ongoing monitoring of the management system as part of compliance monitoring (e.g., by internal audits),
- Management of significant changes in the MO,
- Issuance of Certificates of Release to Service (CRS) after completion of maintenance,
- Procurement, warehousing, and providing of parts and materials for maintenance, archiving of records.
3.2. PRIVILEGES
Privileges of an approved maintenance organization (MOA) may include:
- Issue of a certificate of release to service (CRS) upon completion of maintenance for an aircraft (145.A.50(a)),
- Issue of EASA Form 1 certificate of release to service after completion of maintenance for a component for the following activities (145.A.50(d)):
- Overhaul (Overhauled),
- Repair (Repaired),
- Inspection / Test (Inspected / Tested),
- Modified (Modified),
- Issue of EASA Form 123 Certificate of Release to Service after implementation of a standard modification / standard repair to an ELA 1 or ELA 2 aircraft.
4.) ACC SERVICES IN THE AREA OF PART 145
4.1. CONSULTATION
- Support in the establishment of processes according to Part 145,
- Support in the establishment of complete management systems according to Part 145,
- Process and procedure optimization in maintenance companies according to Part 145,
- Support in the extension of the scope of approval (Scope of Work),
- Interim Management in the area of Comppliancemonitoringmanagement (CMM),
- Consulting for more efficient implementation of Part 145 requirements, process optimization,
- Introduction of safety management systems (SMS),
- Training concepts tailored to the scope of approval (human factors, SMS Part 145, air law, determination of conformity for certifying staff, materials management and supplier management, etc.),
- Project coaching of staff / teams (compliance manager, operations manager, certifying staff, purchaser, maintenance planner, work planner, project manager, etc.).
4.2. PRODUCTS
- Generic quality management manual with procedures
- Forms and checklists (depending on requirements and complexity)
Part CAMO (CAMO)
QUALITY AND SAFETY REQUIRE TRANSPARENT AND REPETITIVE PROCESSES.
PART-CAMO imposes organizational requirements on operations for management and continuing airworthiness.
1.) SYSTEM REQUIREMENTS FOR THE APPROVED CONTINUING AIRWORTHINESS MANAGEMENT ORGANIZATION (CAMO)
Ensuring that all continuing airworthiness tasks on an aircraft are performed and released in a timely manner is the responsibility of the CAMO.
Mandatory approval standard:
(EU) 1321 / 2014, Part CAMO (for commercially and privately operated aircraft and their components). The approval as CAMO covers only the so-called Scope of Work (SoW): complete aircraft.
2.) CAMO TASKS
Continuing airworthiness tasks include:
3.) REQUIREMENTS FOR APPROVAL AS A CAMO
Important prerequisites for the approval activities on the part of the competent authority and the application (EASA Form 2) are:
Existence of technical, organizational, and personnel requirements to be met for the assigned scope of work, i.e., for example:
4.) MANAGEMENT SYSTEM IN CAMO
A management system (CAMO.A.200) must be established for effective and transparent control of processes and procedures (CAME - Continuing Airworthiness Management Exposition (CAMO.A.300)).
4.1. IMPORTANT CAMO PROCEDURES
CAMO procedures must address the following requirements, among others:
4.2.PRIVILEGES
Privileges of a CAMO may include:
5.) ACC SERVICES IN THE FIELD OF CAMO
5.1. CONSULTATION
5.2. PRODUCTS
PART-CAMO imposes organizational requirements on operations for management and continuing airworthiness.
1.) SYSTEM REQUIREMENTS FOR THE APPROVED CONTINUING AIRWORTHINESS MANAGEMENT ORGANIZATION (CAMO)
Ensuring that all continuing airworthiness tasks on an aircraft are performed and released in a timely manner is the responsibility of the CAMO.
Mandatory approval standard:
(EU) 1321 / 2014, Part CAMO (for commercially and privately operated aircraft and their components). The approval as CAMO covers only the so-called Scope of Work (SoW): complete aircraft.
2.) CAMO TASKS
Continuing airworthiness tasks include:
- Ensuring that all scheduled maintenance tasks are performed and released in accordance with the aircraft maintenance program (AMP) for an aircraft as prescribed by the authority or DAH* by responsible parties (maintenance organization, operator, owner).
- Ensure that all unscheduled tasks (e.g., a repair) for continued airworthiness are approved in accordance with Part 21.
- Ensure that all airworthiness directives, as required by the competent authority, are carried out on affected aircraft,
3.) REQUIREMENTS FOR APPROVAL AS A CAMO
Important prerequisites for the approval activities on the part of the competent authority and the application (EASA Form 2) are:
Existence of technical, organizational, and personnel requirements to be met for the assigned scope of work, i.e., for example:
- Existence of Airworthiness Review Staff (ARS) to perform the airworthiness review
- Ensure effective maintenance planning for aircraft and time or condition limited components
- Ensure effective configuration control for aircraft and components with respect to modifications, repairs, and overhauls that have occurred during the monitoring of continuing airworthiness
- Availability of a safety manager function
- Availability of current instructions for continued airworthiness (AMM, CRM, CMM, SRM, etc.)
- Availability of appropriate location and access to monitored aircraft.
4.) MANAGEMENT SYSTEM IN CAMO
A management system (CAMO.A.200) must be established for effective and transparent control of processes and procedures (CAME - Continuing Airworthiness Management Exposition (CAMO.A.300)).
4.1. IMPORTANT CAMO PROCEDURES
CAMO procedures must address the following requirements, among others:
- Planning of continuing airworthiness tasks based on approved aircraft maintenance programs (AMP),
- Regularly updating maintenance programs and verifying that they are current,
- Qualification of airworthiness review staff (ARS) and other personnel,
- Select and monitor maintenance organizations involved in continuing airworthiness, including other CAMOs (with limited scope in continuing airworthiness management),
- Incident Management (Occurrence Reporting),
- Safety Management System (SMS),
- Continuous monitoring of the management system as part of compliance monitoring (e.g., internal audits),
- Management of significant changes in CAMO,
- Issue or extension of airworthiness certificates (ARC) after satisfactory airworthiness review,
- Archiving of records.
4.2.PRIVILEGES
Privileges of a CAMO may include:
- Continued airworthiness management and issue of ARC (EASA Form 15a or 15b) after satisfactory airworthiness review,
- Management of continuing airworthiness and preparation of recommendations for issuing EASA Form 15a to the competent authorities after satisfactory airworthiness review,
- Subcontracting limited continuing airworthiness tasks to other CAMOs,
- Renewal of ARC (EASA Form 15a or 15b),
- Approval of aircraft maintenance programs (AMP).
5.) ACC SERVICES IN THE FIELD OF CAMO
5.1. CONSULTATION
- Assistance in establishing processes in accordance with Part CAMO,
- Support in the establishment of complete management systems according to Part CAMO,
- Process and procedure optimization in maintenance companies according to Part CAMO,
- Support in the extension of the scope of approval (Scope of Work),
- Support in the creation of maintenance programs and checking that they are up to date,
- Interim Management in the area of Comppliancemonitoringmanagement (CMM),
- Consulting for more efficient implementation of Part CAMO requirements, incl. Part M and Part ML,
- Procedure and process optimization in existing CAMOs,
- Introduction of safety management systems (SMS),
- Training concepts tailored to the scope of approval (Human factors, SMS, Part CAMO, Part M and Part ML for Airworthiness Review Staff, Maintenance Planners, CAMO Engineers, etc...,
- Project coaching of staff / teams (compliance managers, accountable manager, airworthiness review staff, maintenance planners, work planners, project managers, etc.).
5.2. PRODUCTS
- Generic CAME with procedures
- Forms and checklists (depending on needs and complexity)
EN 9100:2018
QUALITY AND SAFETY REQUIRE TRANSPARENT AND REPEATABLE PROCESSES.
1.) DEFINITION
This standard is used to establish, maintain, and continuously improve a quality management system for aerospace companies to ensure product safety, reliability and compliance with regulations and customer requirements.
EN 9100 is based on the structure of ISO 9001.
EN 9100 or other standards from this series (EN 9110 "Maintenance organizations", EN 9120 "Dealers and stockists") cover for the most part the requirements:
2.) WHY IS EN 9100 CERTIFICATION NEEDED?
EN 9100 certification can be an important requirement for suppliers to the aerospace industry, or who wish to become one, in order to be approved as a supplier in the aerospace industry.
3.) ADVANTAGES
The consistent focus of your company on the systematic and targeted fulfilment of the requirements of customers and aviation authorities through the implementation of a quality management system in accordance with EN 9100 demonstrably leads to a continuous improvement in performance in all company processes.
Advantages of a certified quality management system according to EN 9100 can be:
4.) THE WAY TO CERTIFICATION OF THE QUALITY MANAGEMENT SYSTEM ACCORDING TO EN 9100
To achieve certification and demonstrate conformance to the standard requirements, the quality management system must meet the following requirements:
5.) OUR SERVICES IN THE FIELD OF EN 9100
We support you in the establishment of quality management systems according to EN 9100, both in the introduction and in the continuous monitoring and further development of your quality management system.
Already in the planning phase we consider your individual requirements and the urgency of your certification.
5.1. CONSULTATION
With our experience from numerous certification projects, we analyse and evaluate your processes and procedures. We usually proceed in the following six steps:
a. Initial interview: In an initial meeting, we work with you to determine the objectives, scope (resources, duration, and costs), and opportunities and risks of the certification project that could have an impact on the project e.g.:
The aim of the GAP analysis is to identify the weak points and to define work packages and tasks in the project for the introduction of EN 9100.
The GAP analysis can also be performed as part of a pre-audit.
In addition, a SWAT analysis (Strengths, Weaknesses, Opportunities and Threats) can be performed.
c. implementation: In cooperation with you, we develop and optimize your processes and procedures with regard to the fulfillment of the standard requirements. If necessary, we implement the required quality management documentation with you and support you in the implementation as required.
d. certification process: We are happy to support you in commissioning and coordinating with the certification bodies.
In preparation for the certification audit, we conduct the pre-audits of the quality management system according to EN 9100 as a practical test in advance. We are also happy to accompany your internal auditors.
e. maintenance of certification: after successful certification, we support our customers as coaches or internal auditors and offer all-round support in the practical implementation of EN 9100 and customer requirements.
5.2. PRODUCTS
1.) DEFINITION
This standard is used to establish, maintain, and continuously improve a quality management system for aerospace companies to ensure product safety, reliability and compliance with regulations and customer requirements.
EN 9100 is based on the structure of ISO 9001.
EN 9100 or other standards from this series (EN 9110 "Maintenance organizations", EN 9120 "Dealers and stockists") cover for the most part the requirements:
- EASA Part 21, Subparts G and J
- EASA Part 145
- EASA Part CAMO, and
- Others
2.) WHY IS EN 9100 CERTIFICATION NEEDED?
EN 9100 certification can be an important requirement for suppliers to the aerospace industry, or who wish to become one, in order to be approved as a supplier in the aerospace industry.
3.) ADVANTAGES
The consistent focus of your company on the systematic and targeted fulfilment of the requirements of customers and aviation authorities through the implementation of a quality management system in accordance with EN 9100 demonstrably leads to a continuous improvement in performance in all company processes.
Advantages of a certified quality management system according to EN 9100 can be:
- Internationally recognized quality management standard
- Inclusion in the Online Aerospace Supplier Information System (OASIS) database
- objective and reliable evidence of the effectiveness and efficiency of their processes
- Risk management processes
- Continuous improvement of business processes (CIP)
- Efficient management of other integrated quality management systems e.g. according to EASA Part 21, EASA Part 145, EASA Part CAMO and others
- Creation of prerequisites and environment for the implementation of other quality management systems in the areas of environment and occupational health and safety
- Creation of prerequisites for the implementation of other customer requirements such as APQP (EN 9145)
4.) THE WAY TO CERTIFICATION OF THE QUALITY MANAGEMENT SYSTEM ACCORDING TO EN 9100
To achieve certification and demonstrate conformance to the standard requirements, the quality management system must meet the following requirements:
- Procedure, or process for configuration or change management,
- Procedure or process for process control including special processes and PLM (Product Lifecycle Management),
- Procedure or process for supplier management (selection, qualification and monitoring),
- Procedure, resp. process for traceability of products and services (also at the supplier),
- Effective planning and project management incl. procedure or process for the release of defined phases or milestones of product realization (development, manufacturing and after sales),
- Procedure or process for product or service-related risk management (DFMEA, PFMEA and identification of critical parts and key characteristics),
- Procedure, or process for approval of process changes, process and product deviations (error correction actions), and process approvals (e.g., FAI - First Article Inspection),
- Procedure, or process for developing process and inspection documentation,
- Procedure, or process, for dealing effectively with customer requirements (Especially when several different customer requirements have to be considered in one process),
- Procedure, or process for determining process capability and measurement capability,
- Procedure, or process for personnel qualification,
- Documentation, record keeping and archiving of evidence,
- And others
5.) OUR SERVICES IN THE FIELD OF EN 9100
We support you in the establishment of quality management systems according to EN 9100, both in the introduction and in the continuous monitoring and further development of your quality management system.
Already in the planning phase we consider your individual requirements and the urgency of your certification.
5.1. CONSULTATION
With our experience from numerous certification projects, we analyse and evaluate your processes and procedures. We usually proceed in the following six steps:
a. Initial interview: In an initial meeting, we work with you to determine the objectives, scope (resources, duration, and costs), and opportunities and risks of the certification project that could have an impact on the project e.g.:
- Need for and depth of integration of existing EASA Part 21, Part 145, and Part CAMO approvals.
- Need for integration/consideration of additional customer requirements (e.g., NADCAP, APQP, and other standards, procedures, and specific standards)
- Maturity and experience of the organization
The aim of the GAP analysis is to identify the weak points and to define work packages and tasks in the project for the introduction of EN 9100.
The GAP analysis can also be performed as part of a pre-audit.
In addition, a SWAT analysis (Strengths, Weaknesses, Opportunities and Threats) can be performed.
c. implementation: In cooperation with you, we develop and optimize your processes and procedures with regard to the fulfillment of the standard requirements. If necessary, we implement the required quality management documentation with you and support you in the implementation as required.
d. certification process: We are happy to support you in commissioning and coordinating with the certification bodies.
In preparation for the certification audit, we conduct the pre-audits of the quality management system according to EN 9100 as a practical test in advance. We are also happy to accompany your internal auditors.
e. maintenance of certification: after successful certification, we support our customers as coaches or internal auditors and offer all-round support in the practical implementation of EN 9100 and customer requirements.
5.2. PRODUCTS
- Generic quality management manual according to EN 9100 with procedures, if necessary taking into account other customer requirements
- Forms and checklists (depending on requirements and complexity)
SAFETY MANAGEMENT SYSTEM (SMS), Organisation
QUALITY AND SAFETY REQUIRE TRANSPARENT AND REPETITIVE PROCESSES.
1.) DEFINITION
The objective of safety management is to identify hazards to aviation safety and to mitigate or prevent the associated safety risks before they lead to accidents or incidents. Safety management enables an organization to manage its activities in a more systematic and focused manner. When an organization has a clear understanding of its role and contribution to aviation safety, it can prioritize safety risks and manage its resources more effectively to achieve optimal results.
Safety management (Safety Management) is the responsibility of the entire organization, or the entire enterprise that unites individual or multiple aviation-related organizations.
The safety management system is based on the following elements:
1. Safety Policy and Safety Objectives
The requirements for SMS differ slightly between initial airworthiness ((EU)748/2012, Part 21, Subparts G and J) and continuing airworthiness ((EU)1321/2014, Part CAMO and Part 145).
2.) IMPLEMENTATION
INTEGRATED MANAGEMENT SYSTEM (IMS).
Quality Management Systems (QMS) structured in accordance with EASA Part 21, EASA Part 145, or EASA Part CAMO are generally compatible with SMS requirements.
The following overview shows the focus and compatibility of both systems:
1.) DEFINITION
The objective of safety management is to identify hazards to aviation safety and to mitigate or prevent the associated safety risks before they lead to accidents or incidents. Safety management enables an organization to manage its activities in a more systematic and focused manner. When an organization has a clear understanding of its role and contribution to aviation safety, it can prioritize safety risks and manage its resources more effectively to achieve optimal results.
Safety management (Safety Management) is the responsibility of the entire organization, or the entire enterprise that unites individual or multiple aviation-related organizations.
The safety management system is based on the following elements:
1. Safety Policy and Safety Objectives
- Commitment and responsibility of management,
- Safety responsibilities of managers,
- Designation of key persons responsible for the
- Coordination of emergency planning,
- SMS documentation (SMS procedures integrated into the QMS or an SMS manual).
- Hazard identification process,
- Process for risk analysis and mitigation.
- Measuring and monitoring safety (compliance monitoring),
- Management of changes,
- Continuous improvement of the SMS.
- Training (human factors, error management, procedures, etc.),
- Safety communication.
The requirements for SMS differ slightly between initial airworthiness ((EU)748/2012, Part 21, Subparts G and J) and continuing airworthiness ((EU)1321/2014, Part CAMO and Part 145).
2.) IMPLEMENTATION
INTEGRATED MANAGEMENT SYSTEM (IMS).
Quality Management Systems (QMS) structured in accordance with EASA Part 21, EASA Part 145, or EASA Part CAMO are generally compatible with SMS requirements.
The following overview shows the focus and compatibility of both systems:
In organizations that have multiple airworthiness approvals, consideration should be given to the possibility of implementing a cross-division safety management system (SMS) to avoid "competing" safety management (SM) processes and procedures.
3.) ACC SERVICES IN SAFETY MANAGEMENT SYSTEM (SMS)
3.) ACC SERVICES IN SAFETY MANAGEMENT SYSTEM (SMS)
- Perform a GAP analysis to determine the extent of management system non-compliance with SMS requirements based on Part 21, 145 and Part-CAMO requirements including AMC and GM,
- Development and definition of strategies for the introduction and sustainable implementation of SM requirements in your organization,
- Development of new manuals and procedures and adaptation of existing based on GAP analysis,
- training.
Support of certification projects (type approvals)
QUALITY AND SAFETY REQUIRE TRANSPARENT AND REPETITIVE PROCESSES.
1. PRODUCT CERTIFICATION AND PRODUCT CHANGES
Products (aircraft, engines, propellers), as well as parts installed in them, require certification in accordance with applicable regulations.
The scope of certification is determined by the category of the aircraft.
After the certification, a Design approval (Type certificate, Supplemental type certificate and other minor and major changes or repairs) is issued by the competent authority (in the EU, this is EASA) or by Design Organisations accordingly their privileges.
The certification of parts and equipment is part of the product certification and is part of the Type certificate or changes to Type certificate for the entire product. Equipment certified according to CS-ETSO and EASA Part 21, Subpart O is an exception.
To achieve a product certification or to change a product certification, certain organizational requirements according to EASA Part 21 must be achieved.
Depending on the product categories, certifications can be achieved if the following organizational requirements (applications/organizational forms) are demonstrated:
1.1. REQUIREMENTS AS BASIS OF CERTIFICATION OR CHANGE OF CERTIFICATION DEPENDING ON PRODUCT CATEGORY
1.2. VERIFICATION OF REQUIREMENT`S IMPLEMENTATION IN THE DESIGN OF A PRODUCT OR A MODIFICATION OF A PRODUCT OR A MODIFICATION OF PRODUCT
MoC Categorization should be i.a.w. Appendix A to AMC 21.A.15 (b).
1. PRODUCT CERTIFICATION AND PRODUCT CHANGES
Products (aircraft, engines, propellers), as well as parts installed in them, require certification in accordance with applicable regulations.
The scope of certification is determined by the category of the aircraft.
After the certification, a Design approval (Type certificate, Supplemental type certificate and other minor and major changes or repairs) is issued by the competent authority (in the EU, this is EASA) or by Design Organisations accordingly their privileges.
The certification of parts and equipment is part of the product certification and is part of the Type certificate or changes to Type certificate for the entire product. Equipment certified according to CS-ETSO and EASA Part 21, Subpart O is an exception.
To achieve a product certification or to change a product certification, certain organizational requirements according to EASA Part 21 must be achieved.
Depending on the product categories, certifications can be achieved if the following organizational requirements (applications/organizational forms) are demonstrated:
- Demonstration of capabilities via certification program (21.A.14(c));
- Demonstration of capability via agreement to use alternative procedures (ADOA acc. to (21.A.14(b)));
- Demonstrate capabilities via design organization approval (DOA per (21.A.14(a))).
1.1. REQUIREMENTS AS BASIS OF CERTIFICATION OR CHANGE OF CERTIFICATION DEPENDING ON PRODUCT CATEGORY
- Certification specification (CS)
- Environmental protection specification
- Operational suitability data (OSD)
- Special conditions* (SC)
- Specific customer requirements
- Specific Operational requirements
- Industry standards
- Etc.
1.2. VERIFICATION OF REQUIREMENT`S IMPLEMENTATION IN THE DESIGN OF A PRODUCT OR A MODIFICATION OF A PRODUCT OR A MODIFICATION OF PRODUCT
- Verification is planned and performed following to the established Means of Compliance (MoC) considering EASA LOI (Level of Involvement).
- Depending on product categories (e.g. complex or non-complex) or change (minor, major, major - significant) as well as design criticality quality and its novelty, safety analyses and assessments can be performed.
- Verification is based on design qualification through inspections and tests
MoC Categorization should be i.a.w. Appendix A to AMC 21.A.15 (b).
Exemplary representation of a certification process (rough) considering requirements from EASA Part 21, Subpart J (Design Management System) and ARP 4754 "Guidelines for development of civil Aircraft and Systems" and ARP 4761 "Guidelines and Methods for conducting the safety assessment process on civil airborne Systems and equipment":
Abbreviations according to ARP 4761:
FHA – Functional Hazard Assessment
PASA – Preliminary Aircraft Safety Assessment
CCA – Common Case Analysis
PSSA – Preliminary System Safety Assessment
1.3. THE CERTIFICATE IS ISSUED WHEN:
2.) ACC's SERVICES IN THE AREA OF PRODUCT CERTIFICATIONS OR CHANGES IN PRODUCT CERTIFICATIONS
Development and Certification
Safety Analyses and Assessment
Development and implementation of design safety concepts to identify design weaknesses and single points of failure related to function, systems and parts, as well as means to mitigate design risks according to methodologies as per ARP 4761.
Qualification of parts (incl. ETSO and COTS)
Prototyping Activities
FHA – Functional Hazard Assessment
PASA – Preliminary Aircraft Safety Assessment
CCA – Common Case Analysis
PSSA – Preliminary System Safety Assessment
1.3. THE CERTIFICATE IS ISSUED WHEN:
- Compliance with certification requirements has been provided
- Aircraft function or function of its changes and system function meet requirements
- Qualification of parts and systems through inspection and testing is completed
- Flight tests are completed
- Design documents (design data) are available
- Operating instructions (AMM, AFM, etc.) are available
2.) ACC's SERVICES IN THE AREA OF PRODUCT CERTIFICATIONS OR CHANGES IN PRODUCT CERTIFICATIONS
Development and Certification
- Preperation and evaluation of concept designs
- Product development plan including statement of work (development -> certification -> manufacturing -> after sales) based on ARP 4754A, APQP and other requirements.
- Preperation of certification programs considering certification requirements (certification specification, environmental protection specification, etc.)
- Certification basis
- test planning
- prototyping
- Design Verification
- For aircraft, systems and parts
Safety Analyses and Assessment
Development and implementation of design safety concepts to identify design weaknesses and single points of failure related to function, systems and parts, as well as means to mitigate design risks according to methodologies as per ARP 4761.
Qualification of parts (incl. ETSO and COTS)
- Planning of test and inspection activities for verification (e.g. development of test plans for parts and components)
Prototyping Activities
- Organization of prototype parts manufacturing
- Establishing of conformity for test articles (e.g. test specimens)
- Preparation for series production
- Re-certification activities (from prototype to new)
- Configuration management in prototyping phase
Advanced Product Quality Planing (APQP)
QUALITY AND SAFETY REQUIRE TRANSPARENT AND REPETITIVE PROCESSES.
1.) DEFINITION
"Advanced Product Quality Planning" (APQP) is a comprehensive, continuous approach based on project management methodology.
The goal of this approach is to ensure the comprehensive product planning or a change to the product and ultimately the control that all phases of the product realization are completed on time and quality as agreed.
The normative basis for APQP is AS/EN 9145 "Requirements for Advance Product Quality Planning and the
Production Part Approval Procedure".
APQP according to AS/EN 9145 adapts to the product development process as follows. It:
APQP supports the product development process (PDP) and:
Depending on the project, different standard methods (FMEA, QFD, QM plan, etc.) can be applied. Their use can help to standardise the results of the assessments, whereby individual points can be varied or deferred.
The elements and phases of APQP are compatible with the requirements of (EU) 748/2012, Part 21, and can be used as a project management approach to manage the meeting of these specific requirements in a meaningful and structured way.
In practice, APQP has not only demonstrated its effectiveness in the management of product development processes at suppliers of aircraft manufacturers. APQP can also be successfully applied to the development of complete aircraft or their modifications.
2.) PHASES OF THE APQP
1.) DEFINITION
"Advanced Product Quality Planning" (APQP) is a comprehensive, continuous approach based on project management methodology.
The goal of this approach is to ensure the comprehensive product planning or a change to the product and ultimately the control that all phases of the product realization are completed on time and quality as agreed.
The normative basis for APQP is AS/EN 9145 "Requirements for Advance Product Quality Planning and the
Production Part Approval Procedure".
APQP according to AS/EN 9145 adapts to the product development process as follows. It:
- ensures that all activities are performed on schedule and to quality standards;
- facilitates effective communication;
- enables timely resolution and removal of obstacles;
- requires proactive approach to mitigate risks in the Product Development Process;
- it integrates the supply chain into the product development process in a controlled manner.
APQP supports the product development process (PDP) and:
- applies to each component of the PDP;
- standardizes deliverables for each APQP phase;
- evaluates runtime based on the timing and quality of required deliverables using reviews (e.g. PDR, CDR, etc.).
Depending on the project, different standard methods (FMEA, QFD, QM plan, etc.) can be applied. Their use can help to standardise the results of the assessments, whereby individual points can be varied or deferred.
The elements and phases of APQP are compatible with the requirements of (EU) 748/2012, Part 21, and can be used as a project management approach to manage the meeting of these specific requirements in a meaningful and structured way.
In practice, APQP has not only demonstrated its effectiveness in the management of product development processes at suppliers of aircraft manufacturers. APQP can also be successfully applied to the development of complete aircraft or their modifications.
2.) PHASES OF THE APQP
3.) APQP SUITABILITY
Basically, the APQP approach is suitable:
4.) OUR SERVICES IN THE FIELD OF EN APQP
Basically, the APQP approach is suitable:
- for new and for running projects and programmes,
4.) OUR SERVICES IN THE FIELD OF EN APQP
- We train your employees on EN 9145 "Requirements for advance product quality planning and the production part release procedure".
- We evaluate your projects on the basis of the EN 9145 under consideration of aviation legislation requirements.
- We perform GAP-Analysis in your planning and initiate corrective actions or implement them together with you (e.g. avoidance of parallel and competing processes).
- We support you in the development of concepts for the transfer of APQP requirements to your supply chain.
- We support you in communicating with customers who demand the introduction of APQP, with the goal of making the introduction of APQP meaningful and based on already established processes.
Drones / UAS / UAV
Inhalte in Vorbereitung
Integrated Management Systems (IMS) in Aviation
QUALITY AND SAFETY REQUIRE TRANSPARENT AND REPETITIVE PROCESSES.
1.) INTEGRATED MANAGEMENT SYSTEMS IN THE AVIATION INDUSTRY
Especially in quality management systems that must implement the aviation legislation, there is often a challenge to utilise synergy effects in documentation, interfaces to other quality management systems, supplier management, staff qualification, continuous surveillance monitoring, work and operation planning, etc.
To bring more efficiency into the sometimes complicated processes of the aviation industry, integrated management systems can be implemented. It includes the quality management systems, that are already introduced and certified (approved) according to aviation legislation to use synergy effects meaningful.
Meaningful and effectively designed integrated management systems help companies to implement industry and customer specific requirements e.g:
1.) INTEGRATED MANAGEMENT SYSTEMS IN THE AVIATION INDUSTRY
Especially in quality management systems that must implement the aviation legislation, there is often a challenge to utilise synergy effects in documentation, interfaces to other quality management systems, supplier management, staff qualification, continuous surveillance monitoring, work and operation planning, etc.
To bring more efficiency into the sometimes complicated processes of the aviation industry, integrated management systems can be implemented. It includes the quality management systems, that are already introduced and certified (approved) according to aviation legislation to use synergy effects meaningful.
Meaningful and effectively designed integrated management systems help companies to implement industry and customer specific requirements e.g:
- Requirements for approved design and production organisation (DOA und POA) i.a.w. (EU) 748/2012, Part 21, Subparts J und G
- Requirements for approved maintenance organisation (MOA) i.a.w. (EU) 1321/2014, Part 145
- Requirements for continuing airworthiness management organisations (CAMO) i.a.w. (EU) 1321/2014, Part – CAMO
- Requirements for aircraft`s operator i.a.w. (EU) 965/2012
- Advanced product quality planning (APQP i.a.w. EN 9145)
- Risk and safety management systems (RM/SM i.a.w. ISO 31000/ applicable ICAO and EASA regulations)
- IT management systems (ITMS i.a.w. ISO 27001)
- Environmental management system (EMS i.a.w. ISO 14001)
- Occupational health and safety management (OHSAS i.a.w. ISO 45001)
2.) ACC SERVICES IN THE AREA OF IMS
We support you in your plan to introduce efficient and repeatable processes in your organisation. We have already gained extensive experience in planning and implementing concepts for the introduction of integrated management systems.
We support you in your plan to introduce efficient and repeatable processes in your organisation. We have already gained extensive experience in planning and implementing concepts for the introduction of integrated management systems.
- GAP analysis (quality management system and interfaces)
- SWOT analysis
- Planning of integration of single norms and standards into IMS
- Support in preparation of process documentation
- Communication with national aviation authorities and certification bodies
- Audits
- Staff coaching
WHAT MAKES US UNIQUE?
We are flexible and solution-oriented.
We prepare your staff for working independently in this specific environment through targeted coaching and/or training.
We develop solutions together with you. You benefit from the know-how transfer.
We source our know-how from a broad network with connections to experts, even from rare disciplines, and with experience in the development of highly complex systems.
We have excellent relations and experience in cooperation with EASA and German and Swiss national authorities.
We are able to develop and implement safe, "acceptable" solutions even in a short time.
We always approach an efficient solution that is in line with aviation regulations and other requirements (e.g. business)
Contact us for a non-binding consultation!
We are flexible and solution-oriented.
We prepare your staff for working independently in this specific environment through targeted coaching and/or training.
We develop solutions together with you. You benefit from the know-how transfer.
We source our know-how from a broad network with connections to experts, even from rare disciplines, and with experience in the development of highly complex systems.
We have excellent relations and experience in cooperation with EASA and German and Swiss national authorities.
We are able to develop and implement safe, "acceptable" solutions even in a short time.
We always approach an efficient solution that is in line with aviation regulations and other requirements (e.g. business)
Contact us for a non-binding consultation!
