Freshman needs help with ISO 13485 Audit Process

J

Jagoda

#31
It is possible. Many auditors working with consulting organizations. The requirement applies only to ensure that the auditor, who implemented the system is not certified for 5 years (do not certify their own system)
 
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sagai

Quite Involved in Discussions
#32
Hi,

what you wrote
The requirement applies only to ensure that the auditor, who implemented the system is not certified for 5 years (do not certify their own system)
is the one I wrote prior
e certificated body proposing the certificate can not give consulting service for potential and for recent client
and against the one you wrote prior.
best to choose a consultant working with a notified body that will certify your system
But correct me if not.

;)
Regards
Szabolcs
 
S

szszsz

#33
We have an attorney, who has been handling our FDA matters, to help us with FDA QSR. I am assigned to ISO 13485 project and will assist her to build a system that meets both standards.


Well, once you start assembling inside the US your first concern should be 21 CFR part 820, not ISO 13485. And, of course, the rest of the medical devices controls applicable to manufacturers.

Kinda looks like you could use a mentor to sort your regulatory path first.

Good luck,
Ronen.
 
J

Jagoda

#34
Hi,
I understand it as follows:
1: the notified body has a number of auditors
2: one of them consults the implementation of the system. He for 5 years, can not carry out audits in this organization on behalf of the notified body
3: another auditor from the notified body carries out certification audit.
It is commonly practiced even by the leading notified bodies (eg. DQS, TUV)

I understand it as follows:
1: the notified body has a number of auditors
2: one of them consults the implementation of the system. He for 5 years, can not carry out audits in this organization on behalf of the notified body
3: another auditor from the notified body carries out certification audit.
It is commonly practiced even by the leading notified bodies

Tied
Jagoda
 

sagai

Quite Involved in Discussions
#35
I am almost 100% sure, that the same division/firm (regardless the auditor person) of the notified body responsible for the certification proposal can not give for the same client consulting service, I will check its regulatory source actually I think it is in the standard for notified bodies.
I could imagine, there is a contractor working for a notified body responsible for the certification and this contractor can give consulting service for a potential customer but not participating in its audit.
Regards
Szabolcs
 

sagai

Quite Involved in Discussions
#36
It is commonly practiced even by the leading notified bodies (eg. DQS, TUV)
Sorry, it keeps me thinking.

So the Customer goes to the notified body, asking a consulting service for preparation of its company for the ISO whatever certification, the notified body does this service, the customer pays, the customer ask the same for certification, the notified body does and the customer pays, and at the end everybody happy.

Do not you think this process from the independence of audit is more than questionable regardless which employee did the consulting???

Regards
Szabolcs
 
S

szszsz

#37
Thanks. I will pay attention to the difference.


Having experience with ISO 9001, you can also try to implement ISO 13485 However, you must pay special attention to important differences in both systems.
In the implementation of ISO 13485 is helpful to ISO / TR 14969:2004 Medical Devices - Quality management systems - guidanance of the application of ISO 13485:2003
I understand you want to implement and certify the QMS complies with ISO 13485 and FDA. Do you plan to enter the markets of the European Comunithy? If so, you must also meet the requirements of the relevant directive.
 
S

szszsz

#38
Thanks. After I have more knowledge on the matter, I will talk to consulting firms again.

In my country the cost of implementation of ISO 13485 in a small business varies between 10 000 and 40 000 USD and is dependent on the number of consultations (50-100 USD / hour), the scope of activities covered by the system (development, design, production, service, sales) , product classes and the state Technical files.
I know consultants who bring ready-made procedures do not fit the profile of organizations that will never be properly run and become a nuisance to management and employees.
I propose to take a few offers from consulting firms or individual consultants, meet with consultants and evaluate their competence (on the occasion of gathering important information for you.)
It is also best to choose a consultant working with a notified body that will certify your system (the best would be their auditir external).
 
J

Jagoda

#39
Sorry, it keeps me thinking.



the independence of audit is more than questionable

Yes it is.:yes:
It works as follows: External auditors are usually freelance and work with many consulting firms and one Notified body. Consulting firms have different relationships with the NB (eg ownership, equity, etc.), jointly organize trainings, meetings with clients, consultants and determine possible future auditors. I met with this person, and not once.

Regards Jagoda
 
M

Markaich

#40
As a member of the Governing Board for an international certification body I believe I can clear up the misunderstanding regarding consultancy / certification.

The certification company are not allowed (under ISO 17021) to provide consultancy to any client where they are the certification body; the restriction does not operate at auditor level. The CB needs to ensure that the auditors they assign have no connection to the client company or its management system...to this end, they will often impose a 2 year ban.

The likes of DNV etc who apparently provide both consultancy and certification services manage to do this through a strict separation of the different companies. So, DNV's consulting company has no operational connection to their certification company...they are two separate entities in law
 
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