Freshman needs help with ISO 13485 Audit Process

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Ronen E

Problem Solver
Staff member
Moderator
#22
Ronen,

Thanks. I called a couple consulting firms and the quotes are around USD 30,000. We are a small company and ISO 13485 is not mandatory in US, where we are selling the products, so we want to try it by ourselves.
Hi there,

If you already comply with the FDA's QSR (21 CFR part 820) then you are not very far from compliance with ISO 13485. It only reinforces my opinion that it is very doable.

I don't know who or what sort of firms you have contacted, or what scope of work you have discussed with them, but from your description so far, $30K sounds to me tooooooo much!... You could find decent guys who would do a good job of that sort for $10-15K. Hey, I would... but I'm too far away... (and who ever said I'm decent?...:lmao:)

Cheers,
Ronen.
 
S

szszsz

#23
I forgot to mention that we are a distributor right now. We will move assembly line to US. Sorry for the confusion.

I told the firms that we are a small company, will assemble products that we have been selling for many many years, and we need help to set up a QMS.


Hi there,

If you already comply with the FDA's QSR (21 CFR part 820) then you are not very far from compliance with ISO 13485. It only reinforces my opinion that it is very doable.

I don't know who or what sort of firms you have contacted, or what scope of work you have discussed with them, but from your description so far, $30K sounds to me tooooooo much!... You could find decent guys who would do a good job of that sort for $10-15K. Hey, I would... but I'm too far away... (and who ever said I'm decent?...:lmao:)

Cheers,
Ronen.
 

Ronen E

Problem Solver
Staff member
Moderator
#24
I forgot to mention that we are a distributor right now. We will move assembly line to US. Sorry for the confusion.

I told the firms that we are a small company, will assemble products that we have been selling for many many years, and we need help to set up a QMS.
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.
 
M

Markaich

#25
Hi all,

:nope: IMHO you are scaring the guy more than is required...

:yes: It is important to be vigilant and educated, and real-life experience is important, but this is no rocket science...

I believe they can teach themselves anything and everything that they need - especially today, when so many good resources are available online for free. Courses and books can be great but they don't actually replace real-life experience. The only way to gain experience is to... experience!... The choice between a course and a book is many times a matter of personal preference. It has to do with the unique way each and everyone of us absorbs information. For me, courses are usually disappointing (and I attended quite many). When I want to consult or discuss something, I call a specialist or a knowledgeable colleague or a wise friend...

In the OP situation I would consider bringing in an experienced consultant to walk them through the initial certification, ISO 13485, regulation and all, and would look for someone who is not only knowledgeable, but who can, and wants to, also educate and grow other people while doing the job.

He who dares - wins.

Cheers,
Ronen.
My problem with that Ronen is that without he underpinning Knowledge and Understanding (KandU) the books and other literature may be uniteligable, even to the most intelligent reader. This will adversely affect szszsz's ability to deliver...his ability for 'can do'

M
 
J

Jagoda

#26
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.
 
#27
Ronen,

Thanks. I called a couple consulting firms and the quotes are around USD 30,000. We are a small company and ISO 13485 is not mandatory in US, where we are selling the products, so we want to try it by ourselves.
What for? $30,000? Do they want to buy the company? I have some consultant contacts right there in NY who will do a great job for a significantly lower figure! I'd love to know who you asked for a quote!;)
 

sagai

Quite Involved in Discussions
#28
I would not consider that money so outstandingly high, it also includes the implementation, so it is not only a price of a bunch of paper.
In my country, you could by 3-4 consulting months for that money only.
Regards
Szabolcs
 
J

Jagoda

#29
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).
 

sagai

Quite Involved in Discussions
#30
It is also best to choose a consultant working with a notified body that will certify your system
Actually that is not possible, by definition the certificated body proposing the certificate can not give consulting service for potential and for recent client.
Regards
Szabolcs
 
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