How do you know you actually need to seek ISO 13485 certification?

M

MichelleMcR

#1
Hello Cove. :bigwave:

I have spent much of this last week logged in and searching The Cove and other resources for answers for top management at my company. They have asked me to research what it would take to add 13485 to our existing 9001:2008 certification. Primarily, however, my question is how do you know you actually need to seek 13485 certification?

Here is some basic background information about our company: We are an EMS provider that manufactures circuit boards primarily for industrial and agricultural products. We have not done any Design outside of DFM and are exempt (under 9001) from all parts of 7.3, but 7.3.1, 7.3.2, and 7.3.7. We have only been involved in medical devices through the production of circuit boards used in the analysis of medical samples (cell analysis devices, sample preparation devices, lasers).

After some research on The Cove, I've found multiple resources and tools that delineate the differences between the two standards that have been quite helpful. I also found a document (of which I didn't keep a copy & that I have, of course, been unable to find again) that stated that it may be unnecessary for circuit board manufacturers to be 13485 certified as long as our device is a part of a greater assembly and does not come into direct contact with a customer? If this is true we'll just need to educate our sales team on how to respond to that question in a sales call, but my knowledge is very limited beyond 9001.

So, I guess what I'm asking is, outside of a specific customer request/requirement, when does it benefit a circuit board manufacturer to seek 13485 certification?
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
ISO 13485 is a voluntary standard. There is no legal requirement to be registered.

If your medical customers aren't asking for it and are happy with your ISO9001 reg then there really isn't a compelling reason to get it, in my mind.
Maybe there are potential customers that would see it as a plus so it could be a marketing concern?
I would be more concerned with what parts of the FDA 21 CFR Part 820 applies to your medical business... I'm not familiar with electronics so I can't say specifically.
 
R

Reg Morrison

#3
So, I guess what I'm asking is, outside of a specific customer request/requirement, when does it benefit a circuit board manufacturer to seek 13485 certification?
Many contract manufacturers like to have as many badges as possible in order to attract new business. So, it would be natural for a contract manufacturer trying to expand on the medical device sector to seek certification to ISO 13485. If you are deemed a critical supplier to an OEM, their Notified Body might "expect" you to have the certification or be subjected to audits by them.

If you are seeking certification for marketing purposes, be aware: due to the new IAF MD9 document, you would be looking at much longer and costlier audits compared to ISO 9001. Check Annex D of the document.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
Many contract manufacturers like to have as many badges as possible in order to attract new business. So, it would be natural for a contract manufacturer trying to expand on the medical device sector to seek certification to ISO 13485. If you are deemed a critical supplier to an OEM, their Notified Body might "expect" you to have the certification or be subjected to audits by them.
In the medical devices context, "Contract Manufacturer" usually refers to a manufacturer of finished devices. This doesn't seem to be the case of the OP. They may be subject to NB surveillance through the auditing of their clients, but there shouldn't be an expectation for ISO 13485 in that. Sure, NBs may "expect" anything and everything, but I wouldn't recommend making business decisions based solely on that, especially when one is not the party hiring the NB's services.
 

somashekar

Staff member
Super Moderator
#6
Looking at what you say what you do, and reading into ISO13485, 3. Terms and definitions, and in particular the 3.7., you are nowhere a medical device manufacturer.
But, the need for certification is market driven, as said by others.
If your customer is more clear about ISO13485, and you are strong about your ISO9001, (which in itself is so good to any industry when implemented in its true spirits) there is no need of an ISO13485 for you.
You and your customer can however interpret the 3.7 to be applicable to you, and your CB will be more than willing to help you get the ISO13485, which adds to his business, and you take away also the ISO9001 for free ....
 
M

MichelleMcR

#8
I don't have a copy of the standard, yet. Can someone tell me what Terms and Definitions 3.7 says or where to find it online, for now? I have found all sections starting at 4 online somewhere, but none of the first 3 sections (although, I do know what the titles of the sections are).

Also, I am confused by the classifications of the devices. I have found definitions of Class I, II (a & b), and III devices issued by the FDA. Are these the classifications everyone is using?
 
V

Vthouta

#9
Hi Michelle,

It would be a wise idea for you to go ahead and get ISO 13485 for your manufacturing facility. Since, you are already doing well on the ISO, you can add this medical certificate by taking the help from CB you are currently enrolled with. This will help your sales team to boost for medical devices. Majority of the time the customers look for companies that have certified for ISO 13485, as part of the supplier qualification process for circuit board manufacturers.

The FDA medical device class and IPC-class for circuit boards are bit different. Don't be confused, as we EMS associates use class for IPC.
FDA -medical classes device:
Go on FDA and check for Frequently Asked Questions About
Medical Devices -

Section 3.7:
.7
medical device
any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of
? diagnosis, prevention, monitoring, treatment or alleviation of disease,
? diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
? investigation, replacement, modification, or support of the anatomy or of a physiological process,
? supporting or sustaining life,
? control of conception,
? disinfection of medical devices,
? providing information for medical purposes by means of in vitro examination of specimens derived from the human body,
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
This has been published by ISO 13485 online and just do a quick search on google.

I couldn't post any links, as the forum doesn't allow me, as I'm pretty new to elsmar.

Since you have started research you can buy the Quality standard for your firm to get full access to all sections.

Hope this clears some of your questions.

Vikram
 
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