I´m working in a small company who is currently implementing a QMS according to ISO 13485. This is going to be our initial QMS.

In clause 2 and 3.1 of ISO 13485 it is stated that the definitions and references from ISO 9000 is indispensable when implementing ISO 13485.

Does anyone has any experience to share concerning this issue?

Is there any way to get these definitions and needed references without buying the complete 9000 standard? And secondly, is it really needed to show compliance?

Thanks!

I´m working in a small company who is implementing a QMS according to ISO 13485. This is going to be our initial QMS.

In clause 2 and 3.1 of ISO 13485 it is stated that definitions and references from ISO 9000 is indispensable when implementing ISO 13485.

Does anyone has any experience to share concerning this issue?

Is there anyway to get these definitions and needed references without buying the complete 9000 standard? And secondly, is it really needed to show compliance?

Thanks!

ISO 9000:2005 is a normative document so you should have it anyway.

Stijloor.

Thanks alot for your quick reply!

I´m a newbee within the QMS area, can I ask the simple but naive question, why?

Thanks alot for your quick reply!

I´m a newbee within the QMS area, can I ask the simple but naive question, why?

If you have ISO 13485 or ISO 9001 handy, look under "terms and definitions."

Stijloor.

ISO 9000:2005 is a normative document so you should have it anyway.

Stijloor.

As Stijloor already told you, just get ISO 9000:2005 - QMS Fundamentals and Vocabulary, it will help you a lot. :bigwave:

Thanks, I think I got it!

I´m working in a small company who is currently implementing a QMS according to ISO 13485. This is going to be our initial QMS.

In clause 2 and 3.1 of ISO 13485 it is stated that the definitions and references from ISO 9000 is indispensable when implementing ISO 13485.

Does anyone has any experience to share concerning this issue?

Is there any way to get these definitions and needed references without buying the complete 9000 standard? And secondly, is it really needed to show compliance?

Thanks!

I would also recommend ISO 14969:2005 "Medical devices - Quality management systems - Guidance ont he application of ISO 13485:2003)
I found it very helpful for writing our quality manual and ensuring our QMS met the requirements. We just got our certification last month!

MDQSA,

Thanks for your advice and congratulations to your certification!

I would also recommend ISO 14969:2005 "Medical devices - Quality management systems - Guidance ont he application of ISO 13485:2003)
I found it very helpful for writing our quality manual and ensuring our QMS met the requirements. We just got our certification last month!

The correct document number is ISO/TR 14969:2005 - you missed the TR :)