ISO 13485 - Medical Device Quality Management System Standard

Hello all Covers -
An auditor (consultant doing one of our internal audits) pointed out that our external standards list should refernece EN ISO 13485:2003/AC:2009 and not ISO 13485:2003. I am a little confused with all the prefixes but if we have ISO 13485:2003 and the 2009 Technical Corrigendum 1, can we put "EN ISO 13485:2003/AC:2009" on our standards list (as I understand ISO 13485:2003/AC:2009 is the same as ISO 13485 + 2009 Corrigendum) or if we have to buy EN ISO 13485:2003/AC:2009 to comply?
Any clarification would be appreciated!

Dear all

For the European medical devices directives a list of harmonized standards is published in the Official Journal of the European Union, see here the publication history:

https://www.tecnologias-sanitarias.com/normativa/index.htm

note that the las published on 19 aug 2011 includes the harmonization for 2 standards:
- EN ISO 13485:2003 (ISO 13485:2003) and
- EN ISO 13485:2003/AC:2009 (ISO 13485:2003/cOR 1:2009)

So the quality manuals and certificates must refer now compliance to:

EN ISO 13485:2003 and EN ISO 13485:2003/AC:2009

or as usually abbreviated:

EN ISO 13485:2003+/AC:2009

The EN versions are the ISO version but including the annexes ZA, ZB and ZC which establishes the Essential Requirements of the medical devices directives covered by the standard

Regards

Xavier Canals-Riera

Thank you Xavier. So if I understand your response correctly, we do need to have a version that includes annexes ZA, ZB, and ZC (which are not in our current ISO 13485:2003 + Corr 1:2009)?

Approved Microbiologist for Medical Device

Hi,

I just joined a medical OEM and we were informed by our counterpart from India that we would need to have an approved microbiologist to acknowledge on the micro test report that we will perform. Can anyone advise how can we validate that a person is an approved microbiologist and will not be rejected by CE auditor during our CE application ? My company will assemble ballon + cathether ( invasive ), any one can advise on the product level and process level quality control for invasive device.

Rgds,
WS Ong

Re: Approved Microbiologist for Medical Device

wsong0808 said:

Hi,

I just joined a medical OEM and we were informed by our counterpart from India that we would need to have an approved microbiologist to acknowledge on the micro test report that we will perform. Can anyone advise how can we validate that a person is an approved microbiologist and will not be rejected by CE auditor during our CE application ? My company will assemble ballon + cathether ( invasive ), any one can advise on the product level and process level quality control for invasive device.

Rgds,
WS Ong

Click to expand...

Welcome to the Cove, wsong0808

In India, the Indian FDA (CDSCO) have this concept of "Approved Microbiologist" or "Approved Chemist" or "Approved Pharmacist" wherein the individual has to appear for an interview and based on his proficiency, an APPROVED status is granted.

These individuals are important as they are the only ones who can sign on the documents as final approvers for batch records or certificate of analysis.

You will have to approach the nearest office of the Indian FDA from your facility location. I am sure your Indian colleagues would know of this.

Thanks Ajit for the response. If i get you right, the Indian FDA is the one to grant the approval on the candidate. Will there be any certificate which can prove the candiate is with approved status ? And any validity timeline for the approval status ?

My company is located in Malaysia. I will check with local ministry of health if the same is imposed.

I need to set up the QMS to get my company certified for the ISO9001/ISO13485 and our product with CE marking ( our product is class III under CE calssification ). Can anyone advise how should I go on this ?

Rgds,
WS Ong

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!

infinitereality said:

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!

Click to expand...

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 (broken link removed)) then you are probably doing just fine, as far as medical devices go.

Cheers,
Ronen.

Hi Ronen - Great thanks, that was insightful. I never have thought that the government have that kind of document. Thanks!

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.