What are the major differences between ISO 13485:1996 and ISO 13485:2003?

S

senna

HELP!!!

My company wants to transition from ISO 13485:2000 to ISO 13485:2003. Through my research on this site I know the following:

1) I have until 7-15-2006 to do this
2) ISO 13485:2000 is the same thing as ISO 13485:1996

SO my question is:

What are the major differences between ISO 13485:1996 and ISO 13485:2003?

Thanks for the help
 

Al Rosen

Leader
Super Moderator
If you search the attachments here in the cove, you will find what you are looking for.
 
senna said:
HELP!!!

My company wants to transition from ISO 13485:2000 to ISO 13485:2003. Through my research on this site I know the following:

1) I have until 7-15-2006 to do this
2) ISO 13485:2000 is the same thing as ISO 13485:1996

SO my question is:

What are the major differences between ISO 13485:1996 and ISO 13485:2003?

Thanks for the help
Senna

If you are selling products to Canada you do not have until July of 2006 to convert to the new standard. You only have until March of 2006 to make the upgrade.

With regard to the comparison of ISO 13485: 2000 to ISO 13485: 2003 you should obviously have a copy of the new standard. You should also get a copy of ISO/TR 14969 which is a guidance document explaining the various requirements in the new ISO 13485: 2003 and includes as a supplement an analysis of significant changes from ISO 13485:1996 to ISO 13485:2003. This should give you most of what you need. The rest you can gleen from the various posts here related to various unique questions or issues.
 
A

Aaron Lupo

gwaikle said:
Senna

If you are selling products to Canada you do not have until July of 2006 to convert to the new standard. You only have until March of 2006 to make the upgrade.

With regard to the comparison of ISO 13485: 2000 to ISO 13485: 2003 you should obviously have a copy of the new standard. You should also get a copy of ISO/TR 14969 which is a guidance document explaining the various requirements in the new ISO 13485: 2003 and includes as a supplement an analysis of significant changes from ISO 13485:1996 to ISO 13485:2003. This should give you most of what you need. The rest you can gleen from the various posts here related to various unique questions or issues.


You will also need ISO 14971 Risk Management.
 
C

celeo

Powerpoint explanation of ISO13485: 2003

The attached powerpoint presentation has been around for a while but is still a valid explanation of why the quality standard had to change and what the main differences are. The fundamental change is the 'process' approach instead of the sequenial element approach.

One word of caution to any company that has not upgraded to the ISO13485: 2003 - do it as soon as possible. Do not wait to the last minute as there is going to be a log jam of companies trying to get re-certified and the registrars could take a while to get to you in the line up. It also takes some time to process the paper work before an actual certificate is issued.
 

Attachments

  • 13485 asq.ppt
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R

Roland Cooke

You may wish to revisit your schedule. :eek:

July is when you need the certificate (earlier for Canada).

Your registrar needs time to print and send it to you.

Your registrar needs time to review the audit documentation and confirm the upgrade.

Your auditor needs time to compile and send the documentation to the registrar.

You may need to compile corrective action plans.

You may have to be re-audited a month or so later if you have a significant non-conformity (quite possible when switching systems).

You may be in a queue with every other company wanting to upgrade....


Thus I suggest you speak with your registrar, and especially your regular auditor, as soon as possible to confirm their lead-times and expectations.

The good news is that most people will be flexible about the change-over, and give you some leeway. :)


The bad news is that regulators, especially those with "hard" systems, are not most people.... :eek:
 
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