Cost to obtain ISO 13485 Certification/Registration from Start-up

R

RickRay

#11
I looked into this recently and obtained three separate quotes. The costs were a little hard to compare side-by-side, so I entered the items onto a spreadsheet and came to the conclusion that our initial costs would range anywhere from $5,000 to $16,000 dollars.
 
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J

Jason S

#13
Our company is near completion for ISO 13485 certification. We are about 55 employees, a job shop, and we have our own product line (gas delivery systems). Our laser welding group was driven by customers to gain ISO 13485 certification. We started in June 2012 and our final audit is March 6-8. It's taken pretty much that entire time using an ISO consultant. It will probably take far less time if you have not started production. Our biggest problem was creating a system that fit into how we already did things. A registrar, audit, and certification is roughly 10k-15k. A consultant was about the same for the time period I previously gave. I believe we've spent over 30k on this project. That doesn't include the follow up and recertifications you need after initial certification.
 
#14
Our company is near completion for ISO 13485 certification. We are about 55 employees, a job shop, and we have our own product line (gas delivery systems). Our laser welding group was driven by customers to gain ISO 13485 certification. A registrar, audit, and certification is roughly 10k-15k. That doesn't include the follow up and recertifications you need after initial certification.
Wow! $10-15K? In the USA, Jason? I did some math and that's about double what you could expect to pay...
 
#15
That's about right. 7 audit days for stage 1 + stage 2 audits; travel costs, maybe a short preliminary assessment.. $10-15k is about right.
For 55 people? He didn't mention a pre-assessment! What are you basing your comments on? They aren't design responsible, so a reduction for that would apply, for a start! What auditor day rates are you basing your comments upon, too?

Admittedly, if someone is flying in (to PA) that may inflate the cost, but seriously? 5K variation? It seems high to me.
 
#16
Yes. That is why I used the word maybe. Sorry, but I don't understand the question. How many audit-days do you believe would be necessary for this audit?
I was wondering what the basis of your statements is. Are you using experience of being in a similar company of similar size, technology which went through a CB audit to 13485? Are you a CB auditor who does countless ISO 13485 audits, or are you simply estimating. We have a number of regulars here who have access to the relevant references to determine the "going rate" for such audits. We can't tell your background and the veracity, therefore, of your information. The Cove has an enviable reputation for accuracy of this type of detail.
 
#17
That's all I needed to know. We have some folks who do, once in a while, make "guestimates" when it's better that people seek the correct information from, for example, the source you quoted.

Many people - as I'm sure you know - don't know the IAF documents are publicly available. Since you haven't posted much and your profile says very little about you, I was merely trying to establish the background to your comments, nothing else. Since you've shared that, we'll know in the future.

Thank you for your contribution:agree1:
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#18
Easy fellas. Remember we are professionals. This is a small thing. Let's not make it personal.
 
I

isolytica1

#19
Seven audit days seems high to me along with the cost, but whatever i guess. if you are confident of the QMS, the consultant, save money and skip the pre-assessment.

the exact product was not identified, but it seems from the thread it may be a component in a device rather than a device. most ACCREDITED registrars make sure they are auditing a device before giving 13485 certs. is it actually a medical device? i have seen this before where a customer wants a supplier to have 13485 without understanding the full picture.
IMHO
 
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