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Terminology - Device History Records equivalent in ISO 9001

K

KeriF

#1
I have come from the Medical Device field using ISO13485 and now am working with ISO9001 and I am having trouble with using the proper terms for some things. In this case I am looking for the proper term for what in the Medical Device field we would call Device History Records. Can anyone help me. My co-worker thinks that Device History Record is a term used only in the Medical evice field but we can't find anywhere what 9001 might call them.

Thanks
Keri:)
 

Stijloor

Staff member
Super Moderator
#2
Re: I need help with Terminology

I have come from the Medical Device field using ISO13485 and now am working with ISO9001 and I am having trouble with using the proper terms for some things. In this case I am looking for the proper term for what in the Medical Device field we would call Device History Records. Can anyone help me. My co-worker thinks that Device History Record is a term used only in the Medical device field but we can't find anywhere what 9001 might call them.

Thanks
Keri:)
Keri,

ISO 9001 does not include a "device history record" requirement. The closest that I can think of are records of nonconforming product, especially those records dealing with customer rejected/returned product.

Does that clarify?

Stijloor.
 

GStough

Staff member
Super Moderator
#3
I have come from the Medical Device field using ISO13485 and now am working with ISO9001 and I am having trouble with using the proper terms for some things. In this case I am looking for the proper term for what in the Medical Device field we would call Device History Records. Can anyone help me. My co-worker thinks that Device History Record is a term used only in the Medical evice field but we can't find anywhere what 9001 might call them.

Thanks
Keri:)
Hi KeriF, and welcome to the Cove! :bigwave:

Having come from the medical device field, too, and now working in a dual-registered copmany (ISO 13485 & ISO 9001), I understand what you're saying. :yes:

I think the term you may be looking for is what we refer to as "quality and/or production records". At least that is how our company refers to these records. :agree1: There may be other terms or phrases that other companies use, but this is a pretty common term, I believe, and it works for us.

I hope this helps. :bigwave:
 

GStough

Staff member
Super Moderator
#4
Re: I need help with Terminology

Keri,

ISO 9001 does not include a "device history record" requirement. The closest that I can think of are records of nonconforming product, especially those records dealing with customer rejected/returned product.

Does that clarify?

Stijloor.
You're correct in including records of nonconforming product, Stijloor. These records might also include any deviation approval, material review board decision, inspection and/or test results, etc. This is by no means an all-inclusive list, as there may be other records that are required, depending on the specific product.
 

Ajit Basrur

Staff member
Admin
#5
Gidget has provided great answers.

When DHR is mentioned, it refers to 21 CFR Part 820 or Quality System Requirement of the US FDA. This as you rightly say, is an exclsuive requirement for ISO 13485 / FDA only and not directly mentioned in ISO 9001.

The main intent of DHR is to demonstrate that the device is manufactured in accordance with the DMR and to provide traceability, which is not so explicitly mentioned in ISO 9001.

Therefore, all the production, quality, warehousing data without being compiled togather can be considered equiavalent to DHR requirements :)
 

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