What About Pre-QS Products?

B

BWoods

#1
What kind of issues have you had with products that were designed and released prior to your becoming a "QS house?"

Certainly we don't need to show APQP compliance if the design cycle was completed prior to becoming QS. But what about PFMEAs, Control Plans, etc.? And once we pass the certification, how do you handle PPAPs?

We have several products that are Pre-QS. My intention is to say they are not QS and are not under the QS system. I did that previously in both QS and VDA 6.1 without a problem. But with different auditors. What do you all think? How are you handling these types of problems?
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Staff member
Admin
#2
My experience is you have to have PFMEA, control plan and such for current production items. I have seen clients 'get away with' not having DFMEAs. You have to have the base manufacturing info.

PPAPs are the same as normal.

I don't see why you can't do like you did in the past as far as non-QS products go. You qualify your systems, not your product anyway. PPAP and all the derivitive stuff is a customer requirement.
 
J

J Kay

#3
Take a look at page 113 in the QS-9000, 3rd edition, manual reference to PPAPs, "PPAP Request" and PPAP Retroactivity. This may help you reference to your PPAP concerns.
 
Thread starter Similar threads Forum Replies Date
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
Watchcat How are pre-subs going these days? Other US Medical Device Regulations 1
N Pre-Clinical Performance Testing Design and Development of Products and Processes 3
B How to submit Pre-submission to FDA? US Food and Drug Administration (FDA) 4
DuncanGibbons Pre FAI production terminology AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
leftoverture Pre-Launch vs Safe Launch IATF 16949 - Automotive Quality Systems Standard 15
M Pre-Sub preparation (for de Novo request) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
B In house NIOSH pre Testing accepted by NIOSH? US Food and Drug Administration (FDA) 1
M AS9100D Registrar pre-audit requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 15
S Pre-Submission for Breakthrough Device Designation - What's the threshold? US Food and Drug Administration (FDA) 8
C EU MDR - Annex II 6.1 Pre-clinical and clinical data EU Medical Device Regulations 4
D Deciding whether or not pre-market clinical investigation is required for low risk device EU Medical Device Regulations 5
V Supplier wants to perform pre-qualifications prior to every run instead of locking in parameters. Supplier Quality Assurance and other Supplier Issues 7
F Internal Audit before Pre-Assessment ISO 17025 related Discussions 2
H Queries: RFD & Pre-RFD Program Medical Device and FDA Regulations and Standards News 0
R Gauge R&R on pre-set torque wrench Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
D Pre-Production Capability Assesment Reliability Analysis - Predictions, Testing and Standards 5
M Is there any pre-defined Control plan format/template acc. VDA? VDA Standards - Germany's Automotive Standards 1
D Pre-Submission after 510(K) Submission? Other US Medical Device Regulations 4
J Pre-clinical Studies for RUO Product Other Medical Device Regulations World-Wide 1
M Informational Health Canada guidance document – Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
J Custom-made implants (Class IIb) and pre-commercialization clinical trials in Spain EU Medical Device Regulations 4
C Shipping Medical Devices to US before pre market clearance US Food and Drug Administration (FDA) 1
A UDI requirements for pre-filled combination devices - Box containing a pre-filled device US Food and Drug Administration (FDA) 2
M Informational MDCG 2019-3 Interpretation of Article 54(2)b – Pre- market clinical evaluation consultation procedure with the involvement of expert panels Medical Device and FDA Regulations and Standards News 0
D Redacted pre-submission bundle that you would be willing to share US Food and Drug Administration (FDA) 3
I Bench Testing & Pre-verification vs. Formal verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
D FDA Pre-Submission Meeting Advice US Food and Drug Administration (FDA) 0
M Medical Device News Health Canada – Consultation: Pre-market Requirements for Medical Device Cybersecurity Medical Device and FDA Regulations and Standards News 0
L 510 (K) Pre-Sub meeting - Does it worth? US Food and Drug Administration (FDA) 4
A Examples of Pre-Sub, SRD, PMA Shells and Templates Other US Medical Device Regulations 3
B Manufacturing site relocation of pre amendment Class II medical device Manufacturing and Related Processes 4
A Users won't return devices from pre-CE performance evaluation study EU Medical Device Regulations 3
B GM GP-12 Pre-Launch - They asking for a I chart Statistical Analysis Tools, Techniques and SPC 2
GoSpeedRacer Pre-Work and Study for ISO 13485:2016 Lead Auditor Class ISO 13485:2016 - Medical Device Quality Management Systems 1
S Pre-release version of the upcoming AIAG FMEA Revision 5 FMEA and Control Plans 1
V Is 'Compliance' a pre-requisite or is it ok before Batch Release to Market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
V Writing a Pre-Submission to the FDA 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 51
P EASA STC (Supplemental Type Certificate) on a Pre-mod FAA STC Configuration EASA and JAA Aviation Standards and Requirements 1
H Pre compliance test for Glucometer Other Medical Device and Orthopedic Related Topics 1
V Pre-dispensed API material received in predetermined quantities & given to production Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
R Is pre-conditioning supplier component before incoming inspection tests allowed? Quality Manager and Management Related Issues 16
somashekar Pre-Announced FDA 4 Day Inspection, Class 2 Devices, Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
Q FDA Consensus Standard for PMA (Pre-Market Approval) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
JoCam Format of Health Canada pre-market licence application Canada Medical Device Regulations 3
P Humidity Pre-Conditioning before leakage current and dielectric strength tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 7
V 510(K) Cyber Security Documentation for Pre-market Submission (Templates) Other US Medical Device Regulations 6
A Infusion Pump - Pre-Clearance Inspections Learnings US Food and Drug Administration (FDA) 4
Crimpshrine13 ISO/TS 16949 Pre-Audit Requirement IATF 16949 - Automotive Quality Systems Standard 18

Similar threads

Top Bottom