Trying to get a financially reasonable ISO Certification Body

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yodon

Staff member
Super Moderator
#2
You want an accredited certification body and, although you didn't put bounds on it, "extremely financially viable" is probably out of the question.
 
#3
We are a very small med device company. what are the options for small companies that cannot afford the annual surveillance-3-year-re-certification Cycle? There is got to be a market for it.
 

chris1price

Trusted Information Resource
#4
First ask the question, why do you want ISO13485? You do not say where you are based or where you are trying to sell; but ISO13485 is not required for CE Marking or for sale in USA. These markets only require you to have a suitable quality system.

If your customers are requiring it, consider it a cost of doing business, add it to your overheads and increase your product price or charge the customer directly for it.

At the end of the day, you are asking for two mutually exclusive things, a good certification body will not be cheap.
 

yodon

Staff member
Super Moderator
#5
There is got to be a market for it.
While that sounds reasonable, the CBs don't get a vote. That's all driven by a higher governing body. If you choose to go for certification, you have to play by the rules.

Side note: compliance to a standard is voluntary. You're not required to be certified to enter, for example, the EU market (and as @chris1price points out, not even recognized in the US). Without it, though, clearance for market in those countries that have standardized on it (harmonized) will be more costly and more difficult.
 

John Broomfield

Staff member
Super Moderator
#6
Good morning SMEs Where can I get a good certification body that is extremely financially viable. thanks for your input
Make sure the CB is accredited twice. As a CB and for your scope.

As for financial viability, think like an investor:

What Is the Best Measure of a Company's Financial Health?

Most of us though don’t bother specifying financial selection criteria because we are confident that if our accredited CB goes bust other accredited CBs will pick up the slack (aka order book).

Besides long-term viability you may want to consider adding another CB selection criterion:

“Show me what you do to promote the value of your cert to my future customers*”.

* Your future customers are those sectors or companies from your strategic marketing plan.
 
#7
While that sounds reasonable, the CBs don't get a vote. That's all driven by a higher governing body. If you choose to go for certification, you have to play by the rules.

Side note: compliance to a standard is voluntary. You're not required to be certified to enter, for example, the EU market (and as @chris1price points out, not even recognized in the US). Without it, though, clearance for market in those countries that have standardized on it (harmonized) will be more costly and more difficult.
I have in business for 37 years most of my life in medical devices with J and J Boston Scientific, etc. Quite a change working for a small company where finances are tight. Thus, the reason for my question. Not looking to bypass requirements just looking for a viable alternative for a small emerging organization other than the ones I am used to work with (TUV, Intertek, SGS, etc.)
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8
what are the options for small companies that cannot afford the annual surveillance-3-year-re-certification Cycle? There is got to be a market for it.
Yes, there is a market; The unaccredited, pseudo-accredited and self accredited "players" who are very happy to see you part with your money. The accredited certification process is controlled by mandatory documents, such as the ISO 17021-X series and IAF Mandatory Documents collection. If you want an alternative path, try the Self Declaration of Conformity route and, as long as the interested parties trust that, you are set.

Good luck.
 

Randy

Super Moderator
#9
We are a very small med device company. what are the options for small companies that cannot afford the annual surveillance-3-year-re-certification Cycle? There is got to be a market for it.
You don't have a choice in cycle, duration or anything like that except as Sidney explained and that's basically to find a Snake Oil Salesman. Any accredited CB will have to apply the requirements of IAF MD5-2019 as a starting point.

A rule of thumb for estimating cost? Start with $1400-$1800 per day costs exclusive (rough estimate across the industry) 13485 might be a bit more expensive.
 

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