What is Required to Switch from ISO 9001-2000 to ISO 13845

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Sidney Vianna

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Staff member
Admin
#12
Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

and ,, may i ask , just what would these added procedured be??

( had to ask)....

I have spent the morning reading ALOT...
Every time you read the terms "documented procedure", it means a documented procedure:cool: . Suggest you use a highlighter. Others might provide you with a list.
 

GStough

Staff member
Super Moderator
#13
Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

Every time you read the terms "documented procedure", it means a documented procedure:cool: . Suggest you use a highlighter. Others might provide you with a list.
In addition, where it states "documented requirement", this may not necessarily mean an actual procedure, but you must have whatever that requirement is documented.
 
W

wrustywrench

#14
Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

OK,,,I have spent a long time getting friendly with a highlighter... I have checked and doubled checked the " required procedures" , and " required documents"...I was just curious of a list would be floating around somewhere.

( cheating)....

Got a copy of FDA 21 cfr 820 on the way,,, along with something else that was recommended to read.

I have read through all the differences in annex b....honestly,, still doesnt make a whole lot of sense....lol
 

Jim Wynne

Staff member
Admin
#15
Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

OK,,,I have spent a long time getting friendly with a highlighter... I have checked and doubled checked the " required procedures" , and " required documents"...I was just curious of a list would be floating around somewhere.

( cheating)....

Got a copy of FDA 21 cfr 820 on the way,,, along with something else that was recommended to read.

I have read through all the differences in annex b....honestly,, still doesnt make a whole lot of sense....lol
Did you check the link I provided above?
 
W

wrustywrench

#17
Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

we are only going to be making parts for another firm. No engineering involved. No shipping ( other than delivery pack to the vendor).

I have another question, the 21 CFR 820, do you become registered to that also? From what I have found, the ISO 13485 coveres all of that too.

thanks
 

GStough

Staff member
Super Moderator
#18
Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

we are only going to be making parts for another firm. No engineering involved. No shipping ( other than delivery pack to the vendor).

I have another question, the 21 CFR 820, do you become registered to that also? From what I have found, the ISO 13485 coveres all of that too.

thanks
No, you don't become registered to the 21 CFR 820. It is something that must be complied with, and by becoming registered to ISO 13485, it is implied or understood that you are also compliant to 21 CFR 820.
 
W

wrustywrench

#19
Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

Well, its nice to be right ...Thanks for the reply.

I am reading the 21 CFR 820 right now. I love this stuff....:cool::lmao:
 
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