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Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records
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Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records
Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records
Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records
Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records
Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records
Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records
Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records
Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records
Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records
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Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records


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definitions, iso 13485:2016, records (evidence) and records control
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  Post Number #1  
Old 15th May 2017, 04:26 AM
ehrbs27

 
 
Total Posts: 4
Question Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records

In the '4.2.5 Control of records', the standard requires the document procedures to define the controls needed for the integrity.
I don't know about the integrity meaning in this standard.
Please help me

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  Post Number #2  
Old 15th May 2017, 09:22 AM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,099
Re: the meaning of the INTEGRITY in ISO 13485

Integrity = wholeness.

The requirement is basically to prevent you to tore it to pieces in a way that make it unreadable.
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  Post Number #3  
Old 15th May 2017, 09:10 PM
ehrbs27

 
 
Total Posts: 4
Re: Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records

Thank you for your reply.
But I do not understand yet
Does it mean to preserve the document perfectly?
Or not to seperate the contents of 'record'?
  Post Number #4  
Old 15th May 2017, 09:16 PM
Marcelo Antunes's Avatar
Marcelo Antunes

 
 
Total Posts: 3,099
Re: Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records

Quote:
In Reply to Parent Post by ehrbs27 View Post

Does it mean to preserve the document perfectly?
If that's required to "provide evidence of conformity to requirements and of the effective operation of the quality management system", yes. But lease note that you define the controls.

Quote:
Or not to seperate the contents of 'record'?
Hum, I'm note sure what you mean here.
  Post Number #5  
Old 15th May 2017, 09:33 PM
ehrbs27

 
 
Total Posts: 4
Re: Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records

Quote:
In Reply to Parent Post by Marcelo Antunes View Post

If that's required to "provide evidence of conformity to requirements and of the effective operation of the quality management system", yes. But lease note that you define the controls.
OK
Oh, i understand it.

Hum, I'm note sure what you mean here.
I mean, do not divide as you like. for example, if you have a record "a/b/c/d/", then you should not divide it by "a", "b", "c" or "d"
  Post Number #6  
Old 16th May 2017, 06:40 AM
Jean_B

 
 
Total Posts: 32
Re: Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records

Quote:
In Reply to Parent Post by ehrbs27 View Post

I mean, do not divide as you like. for example, if you have a record "a/b/c/d/", then you should not divide it by "a", "b", "c" or "d"
I'd say you can still divide it to a, b, c and d parts, as long as removal of any one of the parts is prevented or noticeable.

For example, a summary record of e (all of the above) on a, b ,c and d means you can no longer delete and c and never know it existed.
Another way would be to reference for example this as being part 2 of 5. This would be similar to page numbers which can also denote wholeness or integrity of a document.

Taking it to the next level would involve test-suite setups, where later sections do not replace the previous one in an identifiable (e.g. part 2 under rev 1 to a different part 2 under revision 2) but take a unique place in an expansive set.
This is the core principle behind the often little understood practice of decadal (groups of ten) increments in manual maintenance of for example requirements documentation. This practice allow additions to the requirements set later on to still follow some imposed logical structure (for a little while). Else it could seem that a requirement has either transformed (replacement damages long-term integrity of directly referencing the requirement without the higher-level document identifier) or having a catch-all 'these all came later' numbered set of additional requirements at the end making reading and execution of protocols more difficult.
  Post Number #7  
Old 16th May 2017, 08:30 AM
Ninja's Avatar
Ninja

 
 
Total Posts: 809
Re: Integrity - The meaning of the word INTEGRITY in ISO 13485 Control of Records

Quote:
In Reply to Parent Post by ehrbs27 View Post

In the '4.2.5 Control of records', the standard requires the document procedures to define the controls needed for the integrity.
You can find them.
Everyone who needs to access them can find them.
They are not lost.
They are not changed.
I can trust that when I read it, I am reading the correct version.
When I read it, I can see all of it.
No one changed it without authorization.
It can still be trusted after your computer network crashes.
Bob on the shop floor didn't mark up changes on it when he was angry.

Whole. Trustworthy. Reliable. Complete.

Data Integrity: Data integrity is the maintenance of, and the assurance of the accuracy and consistency of, data over its entire life-cycle. {Wiki definition...and right on the money}
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