Basic questions about earning TSOA (Technical Standard Order Authorization) and PMA

P

PHANTOM

1. I'm trying to understand what it really takes to earn a TSOA. Its not just about getting design approval and being able to throw together a part you can sell. Does the FAA look at say, material control, MRB, quality system, the qualification of your workers perhaps? How much scrutiny comes from the FAA or do they simply say "Your paperwork looks good, your test data is good, call us when your done".

2. I am guessing OEMs want to be quite particular about who is holding PMA for their necessary parts. Does the OEM have any say in who gets PMA or is it strictly an FAA decision? Does the manufacturer have to satisfy both? Is it common for a manufacturer to receive design data from the OEM?
 

Stijloor

Leader
Super Moderator
Re: Basic questions about earning TSOA (Technical Standard Order Authorization) and P

A Quick Bump!

Can you help a fellow Cover??

Thank you very much!!
 

errhine

Involved - Posts
Re: Basic questions about earning TSOA (Technical Standard Order Authorization) and P

1. I'm trying to understand what it really takes to earn a TSOA. Its not just about getting design approval and being able to throw together a part you can sell. Does the FAA look at say, material control, MRB, quality system, the qualification of your workers perhaps? How much scrutiny comes from the FAA or do they simply say "Your paperwork looks good, your test data is good, call us when your done".

2. I am guessing OEMs want to be quite particular about who is holding PMA for their necessary parts. Does the OEM have any say in who gets PMA or is it strictly an FAA decision? Does the manufacturer have to satisfy both? Is it common for a manufacturer to receive design data from the OEM?

In Short:
1. There is a lot that goes into earning the TSO Authorization letter. After all of the work with the ACO for certifying the design, the ACO will request the local MIDO to oversee the production. This includes multiple audits with a frequency and type depending on your risk level. I would recommend reading FAA Orders 8120.22 and 8120.23 to start with. The RGL is your best friend and all of the current orders can be found there. http://rgl.faa.gov/
Ensure that you have a good relationship with both the ACO and the MIDO during the application process and while you maintain the Production Approval.

2. As for PMA, The easiest way to obtain approval is through the airframer (OEM). All it takes is to request the letter of technical assistance from the Type Certificate holder and then apply to the MIDO. It really depends on the OEM if they will provide this letter. Some of the larger airframers will give them to the supplier with no problem, others will refuse the request. If you hold the TSO for the part you do not also need PMA. For the less friendly way to get PMA, you would need to show identically through an alternate route such as test and computation. This eliminates the OEM from the equation and you would apply to the ACO. For more information research FAA Order 8110.42D (also on the RGL).

Good luck!
 
Thread starter Similar threads Forum Replies Date
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
E Basic Risk based thinking questions Risk Management Principles and Generic Guidelines 5
F ISO 9001:2008 Fundamentals: Basic Questions - Controlled Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M SPC, Moving Range Chart and Weighted Graph Basic Questions Statistical Analysis Tools, Techniques and SPC 1
Q Basic questions about AS9100C Quality Standard Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A ISO 27000 (Information Security Management Systems {ISMS}) Basic Questions IEC 27001 - Information Security Management Systems (ISMS) 8
M Basic Gage R&R Sample Questions APQP and PPAP 22
C ISO 9001 CB Auditors - What are their basic questions General Auditing Discussions 22
E Basic questions regarding Nuclear Quality Assurance standards Various Other Specifications, Standards, and related Requirements 15
K NCR (Nonconformance Report) - Basic questions - When should an NCR be filled out? Nonconformance and Corrective Action 5
Q NCR, Containment Action, CAR - Some Basic Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
P Help With Basic Minitab Questions! Using Minitab Software 6
H Basic questions about Installation, Operational & Performance Qualification - PCBA Qualification and Validation (including 21 CFR Part 11) 11
S Basic questions about FMEA - Opinions please FMEA and Control Plans 7
S Basic PFMEA (Process Failure Mode Effects and Analysis) Questions FMEA and Control Plans 22
R Basic Quality Manual Questions Quality Management System (QMS) Manuals 4
C ISO 14001 Requirements - Three Basic Questions Miscellaneous Environmental Standards and EMS Related Discussions 2
R EMDN and Basic UDI-DI EU Medical Device Regulations 6
D Profile callout to a basic dimension calculation Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
T PMCF Surveys for Class II a devices: basic requisites EU Medical Device Regulations 0
T PMCF Surveys for Class II a devices : basic requisites CE Marking (Conformité Européene) / CB Scheme 0
S BASIC UDI-DI for a class IIa device marketed in a Procedure kit EU Medical Device Regulations 1
R Basic Lab Practices - related to ISO 17025 testing labs ISO 17025 related Discussions 1
D Basic udi-di to not appear on IFU? EU Medical Device Regulations 4
T Customer Rejecting Part for Basic Dimension Inspection, Prints (Drawings), Testing, Sampling and Related Topics 16
G SRN, Basic UDI, Legal Manufacturer EU Medical Device Regulations 6
A Basic UDI and UDI-DI for hip implant systems EU Medical Device Regulations 1
P Basic UDI-DI and Legacy Devices EU Medical Device Regulations 19
M Brand owner or manufacturer responsible for Basic UDI-DI and UDI-DI? EU Medical Device Regulations 8
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q GMDN Registration Basic preliminary Information EU Medical Device Regulations 0
M Basic UDI and technical documentation EU Medical Device Regulations 8
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
B Seven Basic Quality Tools (January 23) [Paid] Training - Internal, External, Online and Distance Learning 1
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
J How to measure a Critical Characteristic that is a Basic Dimension Misc. Quality Assurance and Business Systems Related Topics 6
M EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required EU Medical Device Regulations 3
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
F MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI EU Medical Device Regulations 0
L Unacceptable risk for basic safety prior to or after mitigation? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
S Question about a basic additive variance/tolerance example Quality Tools, Improvement and Analysis 2
M Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI Medical Device and FDA Regulations and Standards News 0
Marc Basic - How to Start a New Discussion Thread Elsmar Xenforo Forum Software Instructions and Help 1
S Basic Dimension W/O using FCF Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
V Carbon Black (Master Batch) - Basic Requirements Manufacturing and Related Processes 5
G Setting Up a Basic Quality Lab for a small manufacturing company General Measurement Device and Calibration Topics 2
P Basic Minitab Help - It's about Linear Regression Using Minitab Software 1

Similar threads

Top Bottom