My company is planning to go for ISO 13485 adequacy audit on February 2004. But according to the auditor from SGS, the authorisation for auditing in accordance with ISO 13485:2003 is not given yet. The actual time is not known. But my customer is going to export the products to EU mid of next year, thus we need to be certified for ISO 13485 in order to get CE mark. Thus, if we are in hurry for the certification, the auditor advised us to go for ISO 13485:1996, then update to the latest version once it released. In doing this, we need to spend more on the certification where our budget is not allowed.

Anybody got any idea of the exact time for the commencing of the ISO 13485:2003?

I'm trying to find this out also. I contacted the RAB (in the USA) and they sent me an email back stating basically that they were "in the process" of getting things established but they had not approved any registrars yet. I've heard some rumblings that UKAS may be a little further ahead, but no real solid evidence. Who is the accrediting body for Maylaysia? Maybe you could try contacting them to see how close they are to getting some registrars approved...

I'm in the midst of an audit right now, BSI, and I posed the question. Our auditor says that BSI will be going through their registration process later this month. From there, they will work off any deviations to recieve the green light to issue certificates.

May 2004 sounds like a safe bet that you'll be able to register once and under budget, at least with BSI. SGS is a solid firm and the predominant registrar in Asia. My guess is that they'll be on a similar path as BSI as they have a host of clients to support. I'll post here if I get any further word.

Regards,

Kevin

Our auditor is SGS as well and they have told me to expect their accreditation to be through by spring.

What you can do to ensure you don't change you plans is to carry on implementing ISO13485:2003 and get audited against ISO13485:1996 This will be must easier in the long run. I have put a checklist for implementing this on this forum somewhere but send me your email address and I will send it directly to you.

this will not cost you any more money. upgrade at the another audit when you are ready.

You don't need ISO13485 to get a CE mark. ISO13485 is a QUALITY SYSTEM for Medical devices. Grant it, it helps attain the goal of acheiving the CE Mark but this is a product certification. I would be concentrating more on putting the technical documentation and Essential requirements in place! Check the European directive 93/42/EEC MDD this will give you other routes to getting the CE mark.

Looks like good advice!!

Thanks Kevin.........means something coming from you. I have taken a lot of advice from your posts!

You don't need ISO13485 to get a CE mark. ISO13485 is a QUALITY SYSTEM for Medical devices. Grant it, it helps attain the goal of acheiving the CE Mark but this is a product certification. I would be concentrating more on putting the technical documentation and Essential requirements in place! Check the European directive 93/42/EEC MDD this will give you other routes to getting the CE mark.
Cathy:

That is not completely true. Depending upon the device and the annex of the MDD you may need a 3rd party audited Quality System to get a CE mark to market the device in the EU.

You don't need ISO13485 to get a CE mark. ISO13485 is a QUALITY SYSTEM for Medical devices. Grant it, it helps attain the goal of acheiving the CE Mark but this is a product certification. I would be concentrating more on putting the technical documentation and Essential requirements in place! Check the European directive 93/42/EEC MDD this will give you other routes to getting the CE mark.


Cathy-

While agree with what you are saying about not needing ISO Certification to have your product CE marked, I have to say this. There are Notified Bodies out there that will "force you" to have ISO Certification before they will give you a CE mark. What happened to us was a very long and ugly issue and almost caused us to lose our largest customer. It is a long ugly story that involved TUVPS/MS, if you would like the details feel free to ask me.


AL-

You are 90% correct is stating that you will have to have a third party audit to attain a CE mark, however, depending on the class of the Medical Device you may be able to self CE Mark the product.

ISO GUY:

Not to split hairs. I said, "Depending upon the device and the annex of the MDD you may need a 3rd party audited Quality System to get a CE mark to market the device in the EU."

Also, although you may self certify for a class I device, you still need to meet the requirements of EN 46000 or ISO 13485 before you can self certify, as that is part of what you are certifying. So, just to clarify you need a QMS (3rd party or not) and a Technical File before you can self certify.

There are Notified Bodies out there that will "force you" to have ISO Certification before they will give you a CE mark. What happened to us was a very long and ugly issue and almost caused us to lose our largest customer. It is a long ugly story that involved TUVPS/MS, if you would like the details feel free to ask me.

I am very disappointed to here this. Notified bodies do not run the business and their opinions cannot be forced on you. I would like to talk to you more about this. We are probably :topic: so maybe a new thread?

One thing I make sure I do is keep well on top on the regulatory side so I can't be brain washed by my notified body - in saying that they are very good - but unfortunately you are not the first person I have spoken to about something like this.

I would like to go back to the original question, does anyone have a time frame for 13485:2003 3rd party audit and approval?

The Norwegian branch of DNV Certification has already been accredited by the Norwegian Accreditation Body to issue accredited certificates to ISO 13485:2003.

So, here in the US, due to the lack of an ANSI-RAB NAP ISO 13485 Accreditation Scheme, for the time being, we have been issuing ISO 13485:2003 certificates under the Norsk Akkreditering auspices, which, by the way are members of the IAF.

Attached is the Certificate of Accreditation for the DNV Certification AS in Norway, which lists ISO 13485:2003

...I just want to add my 0.02 EUR to this topic:

It depends on the classification of a device according to Annex IX of the 93/42/EEC MDD whether a QM System is needed or not (for most Class I devices it is not).

If a QM System is mandatory, it has to be assessed by a notified body (to audit the compliance with the reqauirements in the MDD).
The requirements for the QMS are written in the MMD (Annex II, V or VI).

It is not a requirement to have established a QMS after 4600x or 1348x, but it helps.

The actual harmonized standards are listed here:
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html

Note, that EN 4600x:1996 are still valid harmonized standards until 2004-03-01. After that date EN ISO 13485/8:2000 become the "valid" standards, which are almost identical with EN 13485/8:1996.

There is no need for a certification after EN ISO 13485:2003 to get the CE mark (from a notified body), but it helps, if one has establieshed a process oriented QMS.
OTOH there are many more requirements for documented processes and maintaining of records in the 13485:2003 than in 13485:2000.

Conclusion: if you want a QMS after ISO EN 13485:2003, then "do it", otherwise a QMS after ISO EN 13485:2000 will do it for the next few years.

~ghw

Dear All,
I knew through an auditor of CE-Mark and ISO13485 that the certification is not possible at the moment against the year 2003 version as part of the CE-Mark requirements due to the reason that the sterilization standards was not harmonised with the new version yet. The estimate time she gave me is in the first quarter of next year. Anyody can be certified against ISO 13485:2001 and during the next suirvallance visit it can be upgraded to ISO 13485:2003. Providing that the requirments of 2003 are complete and the hole issue have been agreed upon with the registrar

Dear ISO MAN:

I am a little bit curious about that. Could you ask for more detailled information?

The standards for strilization are independent from ISO 13485:2003.
There are the following requirements for sterile products:
---------------
7.5.1.3 Particular requirements for sterile medical devices
The organization shall maintain records (see 4.2.4) of the process parameters for the sterilization process
which was used for each sterilization batch (see 4.2.4). Sterilization records shall be traceable to each
production batch of medical devices (see 7.5.1.1).

7.5.2.2 Particular requirements for sterile medical devices
The organization shall establish documented procedures for the validation of sterilization processes.
Sterilization processes shall be validated prior to initial use.
Records of the results of sterilization process validation(s) shall be maintained (see 4.2.4).
---------------
There are also some standards for strilization listed in the Bibliography.

AFAIK there will be no harmonization between ISO 13485:2003 and any standard für sterilization.

Standards are only harmonized with the MDD 93/42/EEC. The list of the harmonized standards are published here:
http://www.newapproach.org/Directives/Default.asp

The harmonized standards for sterilization of medical devices (EN 55x) are listed there (and they are independen from the standard for quality management systems).

The point is, that EN ISO 13485:2003 is not harmonized with the MMD yet.

Although I disagree with your posting that certification against EN ISO 13485:2003 (as part of the CE requirements) is not possible at present.

You do not need a "EN ISO certificated" quality management system at all as lon as you fulfill the requirements of the MDD.

As I wrote, the harmonized standard fur quality management systems for medical devices is EN 4600x:1996 at present and EN ISO 13485/8:2000 after 2004-03-01.

The new standard is a further development of the old standard, and therefore the presumption of conformity to the MDD still applies.
The title of the new standard "Medical devices - Quality management systems - Reqirements for regulatory purposes" also endorses this assumption.

Hi ,

I need the ISO 13485:2003 standard.

Anyone will to help please do.

Thanks and regards,

Omar

Hi ,

I need the ISO 13485:2003 standard.

Anyone will to help please do.

Thanks and regards,

Omar


Hello Omar,
you can buy it from your local standards organisation or direct from ISO
If I did it correctly this link should bring you to the correct place:

13483:2003 at iso.org (http://www.iso.org/iso/en/CatalogueDetailPage.CatalogueDetail?CSNUMBER=36786&ICS1=11&ICS2=40&ICS3=1)

have fun with the standard ;)

V