Rx-360 - Has Anyone Used This and What Was Your Experience?

GStough

Staff member
Super Moderator
#1
When I contacted a supplier to schedule an audit, their response was a suggestion to use Rx-360. I'd never heard of it, so I wanted to see if anyone here in the Cove has ever used it, and if so, what was your experience?

Thanks in advance for your input. :bigwave:
 
Elsmar Forum Sponsor

GStough

Staff member
Super Moderator
#3
Pretty much, yes. Their parent company, however, has agreed to an on-site audit the week after the date I proposed to visit them! Makes no sense.....
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Pretty much, yes. Their parent company, however, has agreed to an on-site audit the week after the date I proposed to visit them! Makes no sense.....
Kind of like what I was promised when I first embarked the ISO boat - just show us your cert and we won't have to audit you.
Riiiiight....
 
Thread starter Similar threads Forum Replies Date
R Supplier/Vendor Surveys (360) Supplier Quality Assurance and other Supplier Issues 1
A Optical Magnification Checking Graticule - Starrett 400-360 (P-10089) General Measurement Device and Calibration Topics 2
Stijloor 360 Degree View of the Airbus A380 Flight Deck Travel - Hotels, Motels, Planes and Trains 3
BeaBea ISO 9001 Customer Feedback Methods - What has worked for your company? Service Industry Specific Topics 16
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
M Has anyone has been through an MDR audit? (3/2020) EU Medical Device Regulations 1
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 14
B ASA Aviation Supply Association - Has anyone heard of ASA? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
D Has anyone had sudden challenges from Korea-MFDS? Other Medical Device Regulations World-Wide 1
Sidney Vianna IAQG News IAQG has a new website - December 2019 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
Richard Regalado ISO 22301:2019 has been published - Nov 2019 Business Continuity & Resiliency Planning (BCRP) 0
S FAIR - If we have not produced a part in over 2 years, but nothing has changed AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
Nicole Desouza Who has to be compliant with REACH Declarations? REACH and RoHS Conversations 11
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A Would an MRP system that has been in use for over 10 years require validation? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Informational VDI 2017 - Medical Grade Plastics - German VDI has published a "Richtlinie" Other Medical Device Related Standards 1
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
U Hand-Held dosing device has no PATIENT - Interpretation of the PATIENT definition IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Has anyone heard of the 2 pan system? Manufacturing and Related Processes 6
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
I Who has had to move from ISO 9001:2015 to ISO 13485 and what were the challenges? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Informational Health Canada has launched an e-Learning tool to aid in understanding the premarket regulatory requirements for medical devices in Canada Medical Device and FDA Regulations and Standards News 0
M Has anyone here assessed the latest Abbreviated 510(K) guidance document? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Does anyone has a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 3
Sidney Vianna Informational UTC ASQR Rev.11 has a mistake; certification of distributors to IATF 16949 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
lilybef FDA and Biocompatability Testing - Reviewer has requested implantation testing Other Medical Device Related Standards 11
D Has anyone undergone a BARDA (HHS) audit as part of their grant process? Other Medical Device Regulations World-Wide 0
Sidney Vianna LinkedIn bug - Anyone has any idea of how to fix this? Posts not showing for me in a Group feed. Coffee Break and Water Cooler Discussions 2
M FDA News FDA Report - FDA Has Taken Steps to Strengthen The 510(k) Program Other US Medical Device Regulations 0
C Has an amended version of IEC 60601-1-6 TRF been released for use in conjunction with IEC62366-1:2015? Human Factors and Ergonomics in Engineering 0
planB ISO 10993-1:2018 has just been published Other Medical Device Related Standards 2
S ISO 13485 Consultant Question - The company has 5 part time employees ISO 13485:2016 - Medical Device Quality Management Systems 1
K Has anyone used QAI for training? Training - Internal, External, Online and Distance Learning 7
Q MHRA has released a new guidance document related to 'GXP' Data Integrity EU Medical Device Regulations 3
B FDA Philippines has no check or balance outside the health department Supplier Quality Assurance and other Supplier Issues 3
S Doubts about SPC taken in Machining - Part has +-0.01 Tolerance Statistical Analysis Tools, Techniques and SPC 5
D Has anyone here had any experience with PQ-FMEA software? FMEA and Control Plans 1
P NPR Metric - What if Customer has relaxed measure? TL 9000 Telecommunications Standard and QuEST 1
D EU Harmonized Standards to which a company has declared compliance EU Medical Device Regulations 13
N Customer Survey Question Has Me Stumped - Compliance with Laws and Regulations Customer and Company Specific Requirements 4
B Records Destroyed - Hurricane Harvey has likely destroyed our Quality Systems Records Records and Data - Quality, Legal and Other Evidence 10
S Has anyone completed IATF 16949 Certification - Share your Audit Experience? IATF 16949 - Automotive Quality Systems Standard 2
B Procedure Pack - KIT - Each has its own CE Mark CE Marking (Conformité Européene) / CB Scheme 6
E Print only has Reference Dimensions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
S Has anyone created a Turtle Diagram reflecting the new ISO 9001:2015 Structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Who has had a Transition Audit from TS 16949 to IATF 16949 IATF 16949 - Automotive Quality Systems Standard 120
M Has anyone done a Gage R&R for Spectrophotometer? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 10
M Remote Office only has Invoice Function - Audit Needed? IATF 16949 - Automotive Quality Systems Standard 0
Similar threads


















































Top Bottom