Differences Between TS16949 and ISO 13485

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QE

Dear Coves

Please advise the resource to research common elements and Difference between the QMS. ISO 13485 the one applies to medical devices and TS16949 the famous automotive system. Please advise from the tactical / engineering perspective.

QE.
 
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Randy

Super Moderator
They have ISO 9001:2008 in common...Is that what you wanted?

The difference? 16949 is automotive and 13485 is medical and the differences are pretty evident in their titles
 
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QE

Randy

I was trying to identify the differences and similarities at Tactical level. I mean to say at the engineering level.
 

Jim Wynne

Leader
Admin
I was trying to identify the differences and similarities at Tactical level. I mean to say at the engineering level.
It's not clear what you're trying to find out. Are you interested in differences in implementation? Differences in common practice as it relates to engineering? Design engineering? Manufacturing engineering?
 
Q

QE

Jim Wynne, thanks for your email. I have a thought and as we brain storm it together we will have refinement. Right now I am trying to find out the convergence and divergence of practices for career evaluation purposes.


Now, back to the topic say Design and Manufacturing engineering both. Like say Design Controls, Production and Process Controls, Risk Management and CAPA processes are used in Medical device manufacturing - ISO 13485. What are the equivalents to these in Automotive world - ISO TS 16949 ?
 

Jim Wynne

Leader
Admin
Jim Wynne, thanks for your email. I have a thought and as we brain storm it together we will have refinement. Right now I am trying to find out the convergence and divergence of practices for career evaluation purposes.
I'm assuming that by "email" you meant "post," as I didn't send you an email message.

Now, back to the topic say Design and Manufacturing engineering both. Like say Design Controls, Production and Process Controls, Risk Management and CAPA processes are used in Medical device manufacturing - ISO 13485. What are the equivalents to these in Automotive world - ISO TS 16949 ?

I have no experience in medical devices, so I can't help very much, if at all. I was just trying to have you clarify your request. I do know, however, that all of the things you ascribe to medical device manufacturing are also required by TS16949. As Randy pointed out earlier, both standards are based on ISO 9001. I think that risk management, per se, is not emphasized as strongly in 16949 as it is in 13485, but I could be wrong about that.
 

Ajit Basrur

Leader
Admin
Refer this article that highlights the differences between ISO 9001 and ISO 13485. The 9001 concepts could be held valid for TS 16949.

Read HERE
 
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howste

Thaumaturge
Trusted Information Resource
Dear Coves

Please advise the resource to research common elements and Difference between the QMS. ISO 13485 the one applies to medical devices and TS16949 the famous automotive system. Please advise from the tactical / engineering perspective.

QE.

Years ago I put together a comparison matrix that includes both TS 16949 and ISO 13485. You can find it here: DEAD LINK REMOVED

TS 16949 has been updated since then, but the requirements were not changed. You can use it to see side-by-side the differences of the two standards.


Refer this article that highlights the differences between ISO 9001 and ISO 13485. The 9001 concepts could be held valid for TS 16949.

Read HERE
Ajit, there's no link here as far as I can tell...
 
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