SBS - The best value in QMS software

ISO 13485 Certification for Resin Manufacturer

Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
There is no obvious reason why they shouldn't be certified. I know of both polymer and silicone manufacturers who are certified to ISO13485. The bigger question is what is the benefit and do their customers want them to be certified?
 
#3
There is no obvious reason why they shouldn't be certified. I know of both polymer and silicone manufacturers who are certified to ISO13485. The bigger question is what is the benefit and do their customers want them to be certified?
It is not a customer request, it is more to marketing strategy.
They believe, with the ISO 13485 certification, it would be more easier to attract/convince medical device manufacturer to buy their resin.
I am asking this question, because some certification body is query about the medical devices in their certification scope.
 

NikkiQSM

Quite Involved in Discussions
#4
It is not a customer request, it is more to marketing strategy.
They believe, with the ISO 13485 certification, it would be more easier to attract/convince medical device manufacturer to buy their resin.
I am asking this question, because some certification body is query about the medical devices in their certification scope.
I work at a medical resin compounding facility and we are ISO 13485:2016 certified. We did it for both marketing, and to meet our customer's request. We have many very well known customers who would continuously audit us against 13485, regardless of us being 9001, therefore, almost forcing us to update our system to ISO 13485. Its worked well for us. We exclude the clauses that are not applicable, such as sterilization.
 
#5
I work at a medical resin compounding facility and we are ISO 13485:2016 certified. We did it for both marketing, and to meet our customer's request. We have many very well known customers who would continuously audit us against 13485, regardless of us being 9001, therefore, almost forcing us to update our system to ISO 13485. Its worked well for us. We exclude the clauses that are not applicable, such as sterilization.
Thanks for the information, really appreciate it...have a nice day
 
Thread starter Similar threads Forum Replies Date
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 17
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
E ISO 13485 QMS certification as a Supplier ISO 13485:2016 - Medical Device Quality Management Systems 8
J New Job Position - Achieving ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
R Scope of ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 6
T Legalizing ISO 13485 certification with an US state department of health ISO 13485:2016 - Medical Device Quality Management Systems 5
M Informational BSI – ISO 13485 and products with May 2020 deadline for MDR certification Medical Device and FDA Regulations and Standards News 0
S ISO 13485 scope of certification - We are a virtual manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
M Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body Registrars and Notified Bodies 6
H Can an OEM use an CM ISO 13485 certification in helping to get out CE Mark? ISO 13485:2016 - Medical Device Quality Management Systems 2
J Online ISO 13485 Auditor Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
B ISO 13485 certification advantages when I certify a Class 2a medical device CE Marking (Conformité Européene) / CB Scheme 12
S Portugal ISO 13485 Certification and EMC Test Houses Other Medical Device and Orthopedic Related Topics 3
D Gaining ISO 13485 Certification - New Startup Company ISO 13485:2016 - Medical Device Quality Management Systems 5
S Covering an acquired company in our ISO 13485 certification Registrars and Notified Bodies 1
I Should I get IRCA ISO 13485 certification or RAPS certification? Career and Occupation Discussions 3
A ISO 13485:2016 Certification for Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 0
R Scope of Certification for a Design Organization with Outsourced Mfg. - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 10
K ISO 13485:2016 Self Certification for Class I (annex 9) Stand-Alone Software? ISO 13485:2016 - Medical Device Quality Management Systems 3
M OEM-OBL ISO 13485 Certification - Devices mentioned in the product scope ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485 Certification and then CE Mark? EU Medical Device Regulations 8
A Combined ISO 13485 Certification with ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 23
B Reapplying for ISO 13485 certification after certificate revocation ISO 13485:2016 - Medical Device Quality Management Systems 3
N We Passed Our ISO 13485:2003 Certification! Coffee Break and Water Cooler Discussions 7
K Adding a New Site to Our ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 9
S Certification services for ISO 13485, CMDCAS 13485, and CE Markings Canada Medical Device Regulations 18
N What Else is Needed for ISO 13485:2003 certification? ISO 13485:2016 - Medical Device Quality Management Systems 2
M How do you know you actually need to seek ISO 13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 8
G ISO 13485 Certification for one-person startup ISO 13485:2016 - Medical Device Quality Management Systems 7
M ISO 13485 Certification - Internal Audit Program Required ISO 13485:2016 - Medical Device Quality Management Systems 12
R ISO 13485 vs FDA Requirement question about when ISO 13485 Certification is Required ISO 13485:2016 - Medical Device Quality Management Systems 4
A Microbiological Audits Required by CB under ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 9
Q Class I Technical File reviewed during ISO 13485 Certification Audit by NB CE Marking (Conformité Européene) / CB Scheme 10
D Using a different Notified Body for ISO 13485 Certification & Device Certificate CE Marking (Conformité Européene) / CB Scheme 6
D Scope of ISO 13485 Certification needs the word Production. ISO 13485:2016 - Medical Device Quality Management Systems 9
V ISO 13485 certification scope in Spanish ISO 13485:2016 - Medical Device Quality Management Systems 5
Q ISO 13485 Certification for a Fabrication Plant ISO 13485:2016 - Medical Device Quality Management Systems 4
K Which Certification - ISO 13485 vs. ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 8
K ISO Certification Bodies in India for ISO 13485, ISO 14971 & ITIL ISO 13485:2016 - Medical Device Quality Management Systems 5
L Who Accredits Certification Bodies in UK for ISO 13485? ISO 13485:2016 - Medical Device Quality Management Systems 1
S ISO 13485 - Moving towards common (single) certification for multiple locations ISO 13485:2016 - Medical Device Quality Management Systems 13
D Supplier Certification for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
N ISO 13485 Certification - Device Technical File in conjunction with QMS development ISO 13485:2016 - Medical Device Quality Management Systems 5
V Recommendations for Training and Certification for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2

Similar threads

Top Bottom