I need the ISO 13485 Standard manual. Where can I buy it?

A

anookamesh

#1
I need the ISO 13485 Standard manual. Where can I get it? Please list me some websites where i can get them. Thank You In Advance.
 
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RCW

Quite Involved in Discussions
#5
You might want to consider purchasing ISO/TR 14969 INSTEAD of ISO 13485.

Why?

Because 14969 contains the whole 13485:2003 spec AND provides additional explanation of each clause. The 14969 spec in relation to 13485 is just like ISO 9004 is to ISO 9001.

I have both the 14969 and 13485 specs and I find myself always pulling out the 14969.

These are also available from www.iso.ch or www.techstreet.com.
 

amjadrana

Involved - Posts
#7
I would also recommend buying ISO/TR 14969 as well, because the auditors sometimes refer to it as well. ISO 13485:2003 does not say that quality policy has to state that regulatory requirements shall be met. ISO/TR 14969 in section 5.3 does ask for meeting the regulatory requirements. Our auditor insisted that this requirement has to be met and our quality policy has to include regulatory requirements.
 

RCW

Quite Involved in Discussions
#8
Our auditor insisted that this requirement has to be met and our quality policy has to include regulatory requirements.
:soap: That sounds like the auditor overstepped his boundary on that one. 14969 is a technical report, not an international standard like ISO 13485. ISO 14969 is guideline information which includes ISO 13485. I thought just like you cannot be certified to ISO9004, you can't be certified to ISO14969.

Anybody? Is this true or false?
 
G

Gert Sorensen

#9
RCW;181808I said:
thought just like you cannot be certified to ISO9004, you can't be certified to ISO14969.

Anybody? Is this true or false?
I'm not that big on certification, but a quick search on google shows that for instance GE boasts a 9004 certification. I have not heard of the possibility of being certified to 14969 (it is after all a guideline) but maybe one of our visiting auditors can enlighten us. :bigwave:
 
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Ajit Basrur

Staff member
Admin
#10
The question posed in this thread was requesting for ISO 13485 standard manual ...........

I need the ISO 13485 Standard manual. Where can I get it? Please list me some websites where i can get them. Thank You In Advance.
while all responses answered targetted the websites for buying the ISO 13485standard. :cool:

Did anookamesh enquire for buying the standard or ready Quality Manual ? I am :confused:
 
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