Medical Device Repairs and ISO Scope

K

KatieQA

Starting to get Involved
#1
#1
During a recent audit, our auditor mentioned that repair of medical devices (returned by the customer and to be sent back to the customer after repair) required Service be within scope. Can anyone confirm or reject that statement?

Background: we have an active, audited rework program that to date has been used for failures identified prior to release. It is closely tied to our nonconforming material program. We also have an RMA program to handle returned materials from customers for complaint investigations. We have service as a scope exclusion and would not do the repairs on-site at the customer facility. Would those be sufficient to repair and return devices? Or do we need to expand our scope to do repairs?

Thanks!
 
Quickly Organize an Intelligent TDP from DISCUS
Elsmar Forum Sponsor
Tagin

Tagin

Trusted Information Resource
#2
#2
To make sure I understand: are you saying that 1) you DO service (i.e., repair) returned product, and 2) you EXCLUDE service from your scope?

I would think you at least need to remove the exclusion. How do you justify that repairing a medical device should not fall under the same controls, constraints, monitoring, etc. as production of new medical devices??
 
K

KatieQA

Starting to get Involved
#3
#3
Tagin said:
To make sure I understand: are you saying that 1) you DO service (i.e., repair) returned product, and 2) you EXCLUDE service from your scope?

I would think you at least need to remove the exclusion. How do you justify that repairing a medical device should not fall under the same controls, constraints, monitoring, etc. as production of new medical devices??
Click to expand...
We currently do rework for nonconforming material under the same controls as production (approved rework instructions, same controls and inspections, same monitoring). We would like to expand that program to include rework / repair of returned devices. So the controls exist and are implemented, the question is are those controls now called "service" if the product was in the hands of the customer at some point in this process? Is repair different than rework?
 
Tagin

Tagin

Trusted Information Resource
#4
#4
KatieQA said:
....the question is are those controls now called "service" if the product was in the hands of the customer at some point in this process? Is repair different than rework?
Click to expand...
9000:2015, under the definition of 'service' includes:
Note 3 to entry: Provision of a service can involve, for example, the following:
— an activity performed on a customer-supplied tangible product (3.7.6) (e.g. a car to be repaired);
Click to expand...
'Repair' vs. 'Rework' - see 9000:2015 as these are both defined there, and have specific meanings.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G ISO13485:2016 Cl. 7.5.1 - Production and Service Provision - Medical Device Repairs ISO 13485:2016 - Medical Device Quality Management Systems 3
R Regression for MTBF (Medical Device: Repairs vs Install Base) with Reliability Data Reliability Analysis - Predictions, Testing and Standards 16
M Requirements on how long you have to keep Spare Parts for Medical Device Repairs ISO 13485:2016 - Medical Device Quality Management Systems 2
M Medical device certificate in Australia - ARTG certificate Other Medical Device Regulations World-Wide 0
Q Software as a medical device vs software not sold as medical device: local regulations for sale? EU Medical Device Regulations 4
H Medical device Product Registration Registrars and Notified Bodies 2
A Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product. IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Medical device labelling Date of manufacture US Food and Drug Administration (FDA) 2
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
A Clinical assessment sample size - Medical device Class IIb implantable (93/42 directive) EU Medical Device Regulations 2
K 25-year lifetime of medical device - document storage period EU Medical Device Regulations 1
K Relabeling an existing medical device in the field? Other US Medical Device Regulations 6
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
A Reliable sources for following EU medical device regulatory EU Medical Device Regulations 0
T IVDR Medical device software CE Marking (Conformité Européene) / CB Scheme 8
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
J Requirements as a Distributor for Incoming Inspection of Purchased Finished Medical Device Medical Device Related Regulations 0
S Microwave medical waste disinfectant - A medical device or not? Other ISO and International Standards and European Regulations 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
M Is the output of a device a Medical Device? IEC 62304 - Medical Device Software Life Cycle Processes 5
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
L Medical device registration in Iran Other Medical Device Regulations World-Wide 0
H EU CE marking for Medical Device Class I EU Medical Device Regulations 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 4
R Compatibility studies - Medicinal Product and Medical Device Other ISO and International Standards and European Regulations 0
K CE Marking Class 1 (Non sterile) medical device CE Marking (Conformité Européene) / CB Scheme 3
J Medical Device Regulations in Lebanon? Other Medical Device Regulations World-Wide 2
J Calibration cycle for monitoring & measuring tools used in medical device manufacturing General Measurement Device and Calibration Topics 5
S Medical Device MRI Compatibility EU Medical Device Regulations 3
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
R Components to a finished medical device, MDR requirements Other US Medical Device Regulations 1
J Warnings/Cautions in Medical Device IFU Medical Device and FDA Regulations and Standards News 4
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
M V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device) Design and Development of Products and Processes 2
E Medical Device - CE marking - Local market notifications EU Medical Device Regulations 2
S Medical Device Registration in Qatar Other Medical Device Regulations World-Wide 1
M Medical device substance based-leachables Other Medical Device Related Standards 2
P Anyone have an Idea on UAE Medical device registeration- Class B with FDA only Other Medical Device Regulations World-Wide 0
F Mobile app regulations - Class II medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
U Medical Device CE Marking - Using a disposable bearing CE Marking (Conformité Européene) / CB Scheme 3
L Medical Device Registration in Macau Other US Medical Device Regulations 1
A Medical Device Registration in the Dominican Republic Other Medical Device Regulations World-Wide 4
Aymaneh Medical Device Cybersecurity Risk Management IEC 27001 - Information Security Management Systems (ISMS) 2
T B2C Medical Device Shipping across the US Other Medical Device Related Standards 0
M Medical Device Registration In Malaysia Other Medical Device Regulations World-Wide 2
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
V Sister companies selling same medical device under different names ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom