ISO 13485 Certification - Class II product - Fluoride-free toothpaste - Records

D

Diair Marques

#1
Hello everybody!
I am a newcommer to this site and I am really excited about it. Actuallly, I have read most of the threads under medical devices, and learned a lot.

Help needed!!

We are pursuing ISO 13485 certification.
The scope of the audit is for a Class II product designed under the restrict Desing Control requirements. However, the production kick off is in November. KEMA audit is in December.

Our Quality Manual (complaint to ISO 13485) is in place since July. We have operated under the new QMS for the manufacturing of a fluoride-free toothpaste (cosmetic/no claims) since July to validate the System.
Yes, we chose the same approach for the toothpaste (except for Design Control) to make it consistent.

1- Does somebody knows if KEMA will audit the toothpaste records to assess the existing QMS as the only tool to evaluate records? We will have almost zero records for the Class II product by the time they get here. How it works??? :bonk:
 
Elsmar Forum Sponsor
A

Aaron Lupo

#2
Diair Marques said:
Hello everybody!
I am a newcommer to this site and I am really excited about it. Actuallly, I have read most of the threads under medical devices, and learned a lot.

Help needed!!

We are pursuing ISO 13485 certification.
The scope of the audit is for a Class II product designed under the restrict Desing Control requirements. However, the production kick off is in November. KEMA audit is in December.

Our Quality Manual (complaint to ISO 13485) is in place since July. We have operated under the new QMS for the manufacturing of a fluoride-free toothpaste (cosmetic/no claims) since July to validate the System.
Yes, we chose the same approach for the toothpaste (except for Design Control) to make it consistent.

1- Does somebody knows if KEMA will audit the toothpaste records to assess the existing QMS as the only tool to evaluate records? We will have almost zero records for the Class II product by the time they get here. How it works??? :bonk:
Are you going for ISO 13485:2003 or 13485:1996? If you want the toothpaste side of your business to be ISO Certified they will audit the records if not then they won't. We use KEMA as our Registrar and they have been very good.
 
Thread starter Similar threads Forum Replies Date
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 5
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
J General ISO 13485 Certification Assessment Audit Question ISO 13485:2016 - Medical Device Quality Management Systems 1
M Trusting ISO 13485 Certification of a Supplier... A Sad Story ISO 13485:2016 - Medical Device Quality Management Systems 116
S How do I start the process of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 18
S Legacy Products and ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
V Advantages of ISO 13485 or 9001 Certification for FDA Approved and Regulated site ISO 13485:2016 - Medical Device Quality Management Systems 3
Ajit Basrur Is ISO 13485 certification required for distribution company ? ISO 13485:2016 - Medical Device Quality Management Systems 5
C How to avoid ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 9
N Dual ISO 9001 and ISO 13485 Certification for Company with different Product Lines ISO 13485:2016 - Medical Device Quality Management Systems 12

Similar threads

Top Bottom