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ISO 13485 - Medical Device Quality Management System Standard
UL - Underwriters Laboratories - Health Sciences
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
ISO 13485 - Medical Device Quality Management System Standard
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cdsco (central drugs standard control organization), india, iso 13485 - medical device qms, singapore health sciences authority (hsa), medical devices
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  Post Number #25  
Old 25th June 2014, 05:28 PM
Ronen E

Total Posts: 3,386
Re: ISO 13485 - Medical Device Quality Management System Standard

In Reply to Parent Post by gramaley View Post

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.
Hi Grant,

I feel that this thread is diverging a bit too much... What is the topic?

Coming back to my comment - distributors are different from component manufacturers, they require quite different QMSs. Generally I'm in for QMSs that are fit for purpose, including for medical devices distributors. This is not a new concept, and as I mentioned a year and a half ago in this thread, Singapore has given us a very good example with their GDPMD. Australia has a similar guideline (which is unfortunately still voluntary here, probably due to lobbying) - the AUSTRALIAN CODE OF GOOD WHOLESALING PRACTICE FOR THERAPEUTIC GOODS FOR HUMAN USE, which dates back to 1991(!) in it's first issue. I don't buy into the notion of "one size fits all" just because the sign on the from door say "<something> Medical Devices <something>". A high quality, dependable cable harness is a high quality, dependable cable harness, regardless of whether it is used in a MRI machine or a space shuttle.

Component manufacturers should adequately implement a QMS and relevant workmanship (or practices in general) standards, and where health and safety concerns are involved we have regulations and regulatory administrations to protect the public. As seen in the PIP crisis, bodies motivated by commercial considerations are not the best candidates for safeguarding public wellbeing. True, there has also been a major regulatory oversight breakdown, but IMO that's just because of enforcement slack, not because an inherent, conceptual flaw. It seem that steps are being taken now to eliminate that slack.

To highlight my main point, I think that a lot of organizations involved in "the life-cycle of a medical device" can do with an ISO 9001 QMS, provided that it is tailored for their situation and that they actually implement it effectively. Carrying an irrelevant ISO 13485 certificate is just feeding a chain of parasites, unnecessarily increasing the burden for the (component) manufacturer, and - most important - is adding small to zero value for the patient.

If you take out sections 6, 7 & 8 (as the new proposed ISO 13485 revision currently allows), what's left?... Is it any better fit-for-purpose than ISO 9001?


Last edited by Ronen E; 25th June 2014 at 05:36 PM.

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  Post Number #26  
Old 25th June 2014, 05:42 PM

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

Thanks Ronen, and I agree with all the same points. Although it does appear I could have moved off topic, I made a discovery while writing about the component supplier issues, reading my own thoughts. And I think you will agree with this.

At the level of detail of a soldering standard, a wire harness supplier, it is inherently important to have competent auditors that can talk to the people at the plant, and understand their workmanship standards, which in their own language or culture are best understood by native auditors. So in a roundabout way, this was exactly a big point in our promoting use of local auditors, that have met certain international norms for competency and credibility. And yes, IAF has a solid support system for ISO 9001 already serving globally, even for medical device manufacturing abroad. I believe India is only now moving from ISO 9001 to ISO 13485 for medical device QMS.

So I am simply saying that, it is important to know, that your suppliers quality is properly managed. I am also saying, that using local, competent CABs is critical, and so whether you are relying on an ISO 9001 cert or an ISO 13485 cert, make sure they are properly accredited under the IAF framework, to make sure they have a solid foundation under your supplier chain and can really know that those workmanship standards and other factors that support the upstream medical device safety and effectiveness are being taking into account, even where the foreign supplier's methods might not make sense to us "What is the equivalent to IPC standards" for Japan, China or Singapore? Local expertise is far more important than many would give credit for.
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