EDI back-up - Requirement for companies to have a full time EDI back-up?

B

buddybudaboy

#1
Can anyone tell me if it is a specific requirement under the ISO 9000 guidelines for companies to have a full time EDI back-up?
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#2
You may not see it written but it is part of quality records and often document control. In QS-9000 contingency plans require.

Yes - you have to have a backup system commensurate with your system(s). Small company? Keep floppies of important stuff in a 'safe' place. Any more, particularly with companies over 50 people, they look for 'off site' storage (which can be the trunk of a car in the parking lot). 'Normal' is something like daily network backups (don't forget people's PeeCees) with a 2 week history (14 tapes at 1 tape per daily backup).
 
A

Al Dyer

#3
Marc,

I think BBB was refering to electronic comminication (EDI) between customer and supplier for reporting shipping and production requirements. In a previous life we had an EDI account with Chrysler that we had to access every two hours to ensure that we were meeting schedules and get notifications of emergency shipments needed to cover "plant losses"

This was for QS and I'm not sure if it's even a requirement of the new ISO.

Please correct me if I am wrong BBB.

ASD...
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#4
Ah! OK. In ISO it would only be required if it is a specific customer requirement.

Yeah - I think all the 'big 3' require their tier 1's to have backups.
 

E Wall

Just Me!
Super Moderator
#5
Originally posted by buddybudaboy:
Can anyone tell me if it is a specific requirement under the ISO 9000 guidelines for companies to have a full time EDI back-up?
When I worked for a parts supplier we were under QS9000, and we had to keep a backup. The main question in my mind is if the EDI system goes down (same true with any electronic system) what measures are in place to maintain the customer requirements?

Can you duplicate efforts to maintain the customer requirements until communications with the EDI system are restored?
 
Thread starter Similar threads Forum Replies Date
U Automotive History Of Electronic Data Interchange (EDI) World News 1
Stijloor Updated EDI/XML Project Planner available from AIAG Misc. Quality Assurance and Business Systems Related Topics 0
W Has anyone implemented EDI in their organization? Misc. Quality Assurance and Business Systems Related Topics 14
B EDI back-up QS-9000 - American Automotive Manufacturers Standard 1
L PO's & EDI, for the life of the part Document Control Systems, Procedures, Forms and Templates 1
E Language requirement DoC EU Medical Device Regulations 3
I QMS monitoring, measurement, analysis and evaluation requirement - Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Requirement for Signature on Document Document Control Systems, Procedures, Forms and Templates 7
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
W Pfmea function requirement and failure mode FMEA and Control Plans 6
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
J When PPAPs are not a contractual requirement APQP and PPAP 9
I Overwhelmed with attribute MSA requirement for visual inspection IATF 16949 - Automotive Quality Systems Standard 8
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
T ISO 17025: Lockout/Tagout Requirement ISO 17025 related Discussions 1
A The requirement of the PMS plan--suitable indicators and threshold values EU Medical Device Regulations 0
S Battery powered device - electrical protection requirement IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
W Regarding Requirement for Hi pot & Leakage Current test Station Set-up IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Requirement to manufacture under a quality management system EU Medical Device Regulations 4
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
I Laboratory Fridge / Freezer Inventory - Requirement(s) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
Q User Requirement Specification for HR (Human Resource Management System) Manufacturing and Related Processes 1
P Obstruction alarm requirement ISO 80601-2-12 Other Medical Device Related Standards 1
P Electrosurgical Device User Need: Cord Flexibility -> Requirement Other Medical Device and Orthopedic Related Topics 4
C Industrial scales and MSA (IATF 16949 requirement 7.1.5.1.1) IATF 16949 - Automotive Quality Systems Standard 30
C ISO 13485 Requirement in Australia/NZ for class 1? ISO 13485:2016 - Medical Device Quality Management Systems 1
N Label Placement Requirement in MDD/MDR EU Medical Device Regulations 1

Similar threads

Top Bottom