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  Post Number #17  
Old 4th December 2012, 11:49 PM
infinitereality

 
 
Total Posts: 7
Re: ISO 13485 - Medical Device Quality Management System Standard

Hi everyone! We are an independent distributor and I would like to ask if this ISO 13485 is applicable to our business type as we would like to venture into supplying parts to those big contract manufacturers and OEMs of medical devices. Are there any specific medical device QMS standards for distributors / suppliers? I am new to this standard and I would greatly appreciate your replies. BTW, we are certified to the basic three standards: ISO9001, ISO 14001 and OHSAS 18001. Thanks!

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  Post Number #18  
Old 5th December 2012, 04:13 AM
Ronen E

 
 
Total Posts: 3,279
Re: ISO 13485 - Medical Device Quality Management System Standard

Quote:
In Reply to Parent Post by infinitereality View Post

Hi everyone! We are an independent distributor and I would like to ask if this ISO 13485 is applicable to our business type as we would like to venture into supplying parts to those big contract manufacturers and OEMs of medical devices. Are there any specific medical device QMS standards for distributors / suppliers? I am new to this standard and I would greatly appreciate your replies. BTW, we are certified to the basic three standards: ISO9001, ISO 14001 and OHSAS 18001. Thanks!
Hi,

You could apply ISO 13485 to the extant relevant to distribution activities, but you will then probably find out that you are left with the applicable portion of ISO 9001. In other words, you might get certified but there will be no real added value to your current state, other than an image one.

Some organizations in the medical device field hold dear an ISO 13485 certification held by their suppliers, regardless of whether or not it adds real value, so you may find such certification beneficial after all. it depends on who you're working with and what their attitudes are.

In terms of real value, if you follow Singapore's GDP (see http://www.hsa.gov.sg/publish/hsapor..._standard.html) then you are probably doing just fine, as far as medical devices go.

Cheers,
Ronen.
Thank You to Ronen E for your informative Post and/or Attachment!
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  Post Number #19  
Old 10th December 2012, 09:29 PM
infinitereality

 
 
Total Posts: 7
Re: ISO 13485 - Medical Device Quality Management System Standard

Hi Ronen - Great thanks, that was insightful. I never have thought that the government have that kind of document. Thanks!
  Post Number #20  
Old 4th June 2014, 04:45 PM
gramaley

 
 
Total Posts: 85
Re: ISO 13485 - Medical Device Quality Management System Standard

Hello Marcelo,

I was informed that the European co-operation on Accreditation (which includes 35 countries) is going to agree to sign the IAFs Multilateral Recognition Arrangement and begin to enforcing IAF requirements for Accreditation Bodies under IAF MD8, along with ISO 17011, for all those ABs that operate in Europe in support of ISO 13485 certification.

Of course the CABs are already required to enforce MD9 and ISO 17021, but this MD8 and ISO 17011 target upstream Accreditation Bodies, to make sure they are all able to enforce the new international accreditation requirements related that are supposed to support one, more credible ISO 13485 certificate.

This was a really big surprise to see Europe be the first region to adopt the IAF program for ISO 13485.
Thanks to gramaley for your informative Post and/or Attachment!
  Post Number #21  
Old 24th June 2014, 02:57 PM
HFowler's Avatar
HFowler

 
 
Total Posts: 134
Re: ISO 13485 - Medical Device Quality Management System Standard

We are a manufacturer of electrical cable assemblies and wiring harnesses for industrial use. My General Manager wants me to get us registered to ISO 13485 as quickly as possible. Another facility is currently producing components for a medical device customer and we would be part of the risk mitigation for that facility. I am curious as to whether component manufacturers or sub-tier suppliers need to be ISO 13485 registered. We don't produce medical devices. I asked the other facility (in another country) if it is a customer requirement that they be registered and was told that it is. I just want to be sure that someone didn't just see "market and margin" and and say, "let's go for medical device certification". Do medical device companies typically require their suppliers to be ISO 13485 registered?
  Post Number #22  
Old 24th June 2014, 04:29 PM
gramaley

 
 
Total Posts: 85
Re: ISO 13485 - Medical Device Quality Management System Standard

"Required" What does that mean?

If one company "requires" that your company be certified to ISO 13485, you only have to meet that requirement if you choose to do business with them. They are not required to have their supply chain meet ISO 13485, in most cases, unless you are providing them with something that would be considered a medical device in its own right.

A wire harness manufacturer is not making medical devices. In my view, I would much rather know that a supplier of wire harnesses is applying IPC 620, not merely ISO 13485. My risk controls for my medical devices are better managed by targeting specific quality and reliability areas in my component suppliers. Unfortunately a lot of regulatory people don't know very much about IPC standards for workmanship, and they jump to the conclusion that ISO 13485 is a cure for their needs.

Regulators actually know that ISO 13485 is only a means toward managing risks and quality. It really doesn't provide any meaningful guidance on how to properly crimp wires, solder, or inspect electronic assemblies. Most of the companies we work with are operating in Aerospace electronics and have ISO 9001 certs that are properly accredited. They also follow rigorous quality standards that are appropriate for electronics, specifically.

The point I am trying to make is, there is a very clear need for medical device manufacturers to take more seriously, the quality requirements for their products, and stop relying on ISO 13485 as the sole justification for approving suppliers. It is wreckless.

ISO 13485 is very nice, and it certainly does have a lot of tools you can use to think about managing risks, especially when it gets into more serious aspects of risk management under ISO 14971,which is the core "heart and soul" standard that is integrated with of ISO 13485. This is what sets ISO 13485 apart from ISO 9001. However, what you would end up within your ISO 14971 Risk Management System activities is a list of references that simply point back to your workmanship standards.

ISO 13485 demands you have some risk management system. The risk controls (output from the risk management activities) will simply flow out to your product realization activities and more than likely use workmanship standards, like IPC 610, or something you have created that works well enough to "reduce risk" to an acceptable level.

So, unless you are making something that is considered a medical device, you don't need ISO 13485. Maybe your customers want this badly, and may not back down. That may not be in their best interest or yours, it is a business decision, not a regulatory decision. Regulators do not require ISO 13485 from part suppliers, where the parts supplied are not considered medical devices.

You can always just say "No, we aren't doing that". The FDA will not be beating down your door, because they don't require it.
Thank You to gramaley for your informative Post and/or Attachment!
  Post Number #23  
Old 24th June 2014, 06:35 PM
Ronen E

 
 
Total Posts: 3,279
Re: ISO 13485 - Medical Device Quality Management System Standard



A very insightful and important post!

Unfortunately, it seems that the next ISO 13485 revision will effectively move in the direction of application of the standard to component (of medical devices) manufacturers; actually, to everyone involved in "medical devices life-cycle".

Ronen.
  Post Number #24  
Old 25th June 2014, 12:53 PM
gramaley

 
 
Total Posts: 85
Re: ISO 13485 - Medical Device Quality Management System Standard

There is no question that ISO 13485 can be adopted by anyone. And from a business standpoint, it give such a great perception of control, it is very helpful to medical device manufacturers to carry these from their supply chain.

I neglected to mention that in many countries, most medical devices enter the healthcare system via a huge number of distributors, not manufacturers. So in Asia especially, ISO 13485 is becoming increasingly important as a regulatory instrument to regulate distributor GMP. There is new Guidance coming out of the Asian Harmonization Working Party that reflects this in their "Good Distribution Practice" requirements, which is basically modeled after ISO 13485 sections.

So imagine, Singapore has 120 registered manufacturers, and 800+ distributors (I confirmed this with HSA Singapore). So the regulators need to have a "GMP/QSR" types system to help track down where the devices come from, and how they are being managed before entry into the healthcare system. ISO 13485 has some very significant prospects for use here, but I fear that it is not able to really do what people may need most.

If you audit a distributor in Singapore, and find they are importing from 50 different manufacturers from all over the world, how can you know the conditions under which those devices were manufactured, inspected or designed?

Regulatory submissions, such as ASEAN submission used by Singapore HSA help answer some of those questions about the manufacturer's device, which the distributor usually helps register with HSA, but what is really happening at the factories?, how could they know? If you never visit the manufacturer's plant, and inspect the QMS, I think a lot of risk is being taken by these regulators for some of the higher risk devices especially. This is why an affordable, credible, localized infrastructure for certifying to ISO 13485 is the best solution. It is why the IAF created the accreditation system that is now underpinning ISO 13485 worldwide.

We stand now on the verge of being able to determine the credibility of certificates issued in each country, by local CABs, accredited by local ABs, to truly international norms of accreditation. This brings credibility up, but adjusts costs of certification down to local labor costs (not to mention inspection in the native tongue (do you know the Brazil equivalent for soldering workmanship standards)).

ISO is now developing the "CERTO" database, so you won't have to do all the deciphering of a certificates credibility as I presented in this attachment. This will have an initial go-live date of 2015, and I'm pressing for ISO 13485 certs to be part of this. Only IAF accredited certs will be allowed into the database. Client certification data will be uploaded from IAF accredited CABs. This will make it easier than trying to translate a foreign language on a foreign cert at a foreign website.
Thanks to gramaley for your informative Post and/or Attachment!
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