When is ISO 13485:2003 Scheduled for Revision?

T

Tiffany

Hi,

When is the revision of ISO13485 will be revised? Whats the status?

Tiffany
 
Sidney Vianna

Sidney Vianna

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Re: When is ISO13485 Scheduled for Revision?

According to the ISO website, ISO 13485:2003 is in stage 90.93 , which means confirmed. No mention to development of a revision. But since ISO 9001 is being amended next year, and ISO 13485 has a lot of common requirements with ISO 9001, it will probably be 2009 when an amended ISO 13485 will come about.
 
Last edited:
Ajit Basrur

Ajit Basrur

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Re: When is ISO13485 Scheduled for Revision?

Tiffany said:
Hi,

When is the revision of ISO13485 will be revised? Whats the status?

Tiffany
Click to expand...

Generally, 5 years minimum implementation time before a revision can be expected. The version 2003 came after 7 years.

Some of the Standards Under Development by TC 210 are mentioned here

Btw, why are you curious about the new revision ?
 
T

Tiffany

Thanks for all. Curious on the development as rumours told me !:thanx:
 
P

Phoenixber

Hi Everybody,

We just passed our first surveillance audit on Wednesday for ISO 13485. During the audit the auditor did ask us about the version of 13485 we have and noted that we did in fact not have the newest one which we believed was 13485:2003-11. In fact she showed us that the standard was updated to 13485:2007-10 (She showed us the German version of the standard).

Best Regards

Andreas :bigwave:
 
H

harry

Trusted Information Resource
Phoenixber said:
Hi Everybody,

We just passed our first surveillance audit on Wednesday for ISO 13485. During the audit the auditor did ask us about the version of 13485 we have and noted that we did in fact not have the newest one which we believed was 13485:2003-11. In fact she showed us that the standard was updated to 13485:2007-10 (She showed us the German version of the standard).

Best Regards

Andreas :bigwave:
Click to expand...

This is a translated information:

Document: Norm

Ausgabedatum: Issue date: 2007-10

Titel (deutsch): Title (German): Medizinprodukte - Qualitätsmanagementsysteme - Anforderungen für regulatorische Zwecke (ISO 13485:2003); Deutsche Fassung

EN ISO 13485:2003+AC:2007 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003 + AC: 2007

Titel (englisch): Title (English):

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003); German version EN ISO 13485:2003+AC:2007

Originalsprachen: Original languages: Deutsch German

Preis: Price: EUR 117,00 $ 117.00
Click to expand...
 
S

SilverHawk

So, do we have to get the latest ISO 13485 : 2007 version. Is itthe latest?
 
Stijloor

Stijloor

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SilverHawk said:
So, do we have to get the latest ISO 13485 : 2007 version. Is itthe latest?
Click to expand...

According the ISO website, the international (ISO) version of ISO 13485 is still the 2003 issue.

See also Sidney Vianna's post #2 in this thread.

The other one (2007), is a German version of the Standard.

Bottom line? Don't worry! :)

Stijloor.
 
T

Tiffany

Thanks for the latest information to share for all of us here. But what is the difference and changes in this latest standard?

But, anybody can further explain on AC: 2007. What is that about actually...

Thanks....:thanx:
 
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