Embedded Software - I don't understand that

hngrad1977

Starting to get Involved
#1
We are an IATF 16949 facility and are confused as to what the standard means when it discusses 8.4.2.3.1. What do they mean when they say suppliers of automotive product related software, or automotive products with embedded softwre, to implement and maintain a process for software quality assurance for their products.
I don't understand that and what is retained documentation information of a software development capability self assessment. We produce PCB's but the IC's are not programmed. The customer does this. Our test equipment has software from the manufacturer. Can someone tell me what this section means?
 
Elsmar Forum Sponsor
#3
We are an IATF 16949 facility and are confused as to what the standard means when it discusses 8.4.2.3.1. What do they mean when they say suppliers of automotive product related software, or automotive products with embedded softwre, to implement and maintain a process for software quality assurance for their products.
I don't understand that and what is retained documentation information of a software development capability self assessment. We produce PCB's but the IC's are not programmed. The customer does this. Our test equipment has software from the manufacturer. Can someone tell me what this section means?
Yes, it's for suppliers who have software embedded in their products. It sounds like YOUR customer would fall under that, and as Jen says, not you. As you may be aware there are many computer controlled systems on vehicles these days: Body controllers, transmission controllers, engine controllers. The hardware for these all have software embedded - and the requirement affects those, possibly as a result of the VW "Dieselgate" case...
 
Thread starter Similar threads Forum Replies Date
R MSA for ATE (Automatic Test Equipment Embedded Software) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
M 8.3.2.3 Development of products with embedded software - request for clarification IATF 16949 - Automotive Quality Systems Standard 1
K FDA Premarket Submissions for Embedded Software - Level of Concern Other US Medical Device Regulations 4
C Do they use the same standards: Stand-alone software and embedded software? IEC 62304 - Medical Device Software Life Cycle Processes 13
S IEC 62366 - Embedded Software in separate Usability Engineering File? IEC 62366 - Medical Device Usability Engineering 1
T Embedded software requirements - Developer test tools within the same code Qualification and Validation (including 21 CFR Part 11) 3
S Medical Device Embedded Software Classification IEC 62304 - Medical Device Software Life Cycle Processes 4
D Software embedded in a Medical Device IEC 62304 - Medical Device Software Life Cycle Processes 2
S Is firmware or embedded software subject to the same standards as software? Qualification and Validation (including 21 CFR Part 11) 9
A DFMEA for Hardware (Automotive ECU with embedded software) FMEA and Control Plans 3
W Device History Record - Post Shipment - Class II Medical Device w/ Embedded Software 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
S ISO 15504 - 'Embedded Systems' - Software Requirements vs. System Requirements Software Quality Assurance 4
J Control of Electronic Forms and Documents Embedded in Software Document Control Systems, Procedures, Forms and Templates 12
W CPU BIST IEC 62304 - Embedded code has CPU instruction tests IEC 62304 - Medical Device Software Life Cycle Processes 2
G Embedded Systems and C++ Training Company Recommendations (Europe) Training - Internal, External, Online and Distance Learning 2
S CE Marking Requirements for a Product built from Embedded Kit Parts CE Marking (Conformité Européene) / CB Scheme 11
I Assembly Work Surface Cleanliness - Plastic Table Tops and Embedded Metal Chips Manufacturing and Related Processes 9
V Internal Audit Software IATF 16949 - Automotive Quality Systems Standard 5
Watchcat New Draft Guidance on Content of Premarket Submissions for Software Device "Functions" Other US Medical Device Regulations 2
Watchcat Software validation vs design V&V? Other US Medical Device Regulations 27
M Initial Importer/Distributor and Software Validation IEC 62304 - Medical Device Software Life Cycle Processes 1
F Configurator for a power unit - Software or other solution? Manufacturing and Related Processes 0
D Test Management Software Software Quality Assurance 1
E ISO 13485 software validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Tracking software versions used with instruments ISO 13485:2016 - Medical Device Quality Management Systems 0
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
S Do you follow your QMS for non-device software features? Medical Information Technology, Medical Software and Health Informatics 4
J Can we register non-device clinical decision support software under draft guidance? Other US Medical Device Regulations 5
I Software (SaMD) mobile application verification testing: objective evidence Medical Information Technology, Medical Software and Health Informatics 2
J EU equivalent to Clinical Decision Support Software EU Medical Device Regulations 3
Y ISO 13485:2015 Software Validation IQ/OQ/PQ ISO 13485:2016 - Medical Device Quality Management Systems 13
S Recommended software to send Quality scorecards to suppliers (external providers) Supplier Quality Assurance and other Supplier Issues 3
J Software as a Medical Device - SaMD IEC 62304 - Medical Device Software Life Cycle Processes 3
BeaBea QMS/ Training Management Software Service Industry Specific Topics 4
shimonv Working with a software developer who is not setup for IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
R Debug mode in software/device validation IEC 62304 - Medical Device Software Life Cycle Processes 2
Q Gage calibration / tracking software General Measurement Device and Calibration Topics 5
M Software verification and validation AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Y RT-qPCR Software result EU Medical Device Regulations 0
B A.I. diagnostic software is considered as medical device in FDA? US Food and Drug Administration (FDA) 6
F WANTED Senior Software engineer Career and Occupation Discussions 2
P Blood establishment computer software EU classification EU Medical Device Regulations 0
S Examples of FDA acceptable Software Design Specification (SDS) Medical Device and FDA Regulations and Standards News 6
D Integrated Management System Software Quality Manager and Management Related Issues 2
B Sampling strategies/techniques for software QA Software Quality Assurance 3
K MDCG-2020-3 (about the software of UI) EU Medical Device Regulations 3
D PFMEA Software search IATF 16949 - Automotive Quality Systems Standard 7
C MDR software classification EU Medical Device Regulations 12
H Class II a vs "software safety class A" IEC 62304 - Medical Device Software Life Cycle Processes 4
Z Software for design control ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom