Definition Document vs. Record in ISO 9001 Procedure - Differences between and Definition

R

rcm_mech

#1
Hello Friend:D

Let me know Difference between "Document " and " Record" in ISO Procedure.
Logical answers are also welcomed.

Thanks in advance.
 
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J

jequihua

#2
Re: Difference between "Document " and " Record" in ISO Procedure

Hi,

A document can be a procedure, specification, drawing, work instruction and the record is also a document with the difference that it provides evidence of compliance with established requirements and effectiveness of the operation of QMS.

I hope this helps.

Jorge Equihua
 
S

sudwel

#4
Re: Difference between "Document " and " Record" in ISO Procedure

I like to explain the difference as:

Document - can be changed
Record - once completed, cannot be changed

Lots of good definitions for you - hope this helps!
Darlene
 
T

Ted Schmitt

#5
Re: Difference between "Document " and " Record" in ISO 9001 Procedure

As per ISO 9000:2005

3.7.2 document
information (3.7.1) and its supporting medium
EXAMPLE Record (3.7.6), specification (3.7.3), procedure document, drawing, report, standard.
NOTE 1 The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a
combination thereof.
NOTE 2 A set of documents, for example specifications and records, is frequently called “documentation”.

3.7.6 record
document (3.7.2) stating results achieved or providing evidence of activities performed
NOTE 1 Records can be used, for example, to document traceability (3.5.4) and to provide evidence of verification
(3.8.4), preventive action (3.6.4) and corrective action (3.6.5).
NOTE 2 Generally records need not be under revision control.
 

jkuil

Quite Involved in Discussions
#6
Re: Difference between "Document " and " Record" in ISO Procedure

I like to explain the difference as:

Document - can be changed
Record - once completed, cannot be changed

Lots of good definitions for you - hope this helps!
Darlene
Records can be corrected or amended - i.e. changed - once completed
 
Q

QA_chick

#7
Re: Difference between "Document " and " Record" in ISO Procedure

Document says: "DO"
Records says: "DONE"

Stijloor.
:agree1:

A template intended for recording results or other data (such as a form - hard or soft copy) can be considered a document.

The template, once completed, would be considered a record. A record is evidence of activity.
 

Wes Bucey

Quite Involved in Discussions
#8
Re: Difference between "Document " and " Record" in ISO Procedure

Records can be corrected or amended - i.e. changed - once completed
I don't think so! A record is the history of the actvity. We don't normally change history, but it may often be amended as new information comes to light. Certain industries, pharmaceutical among them, have strict proscriptions about altering a record.

:agree1:

A template intended for recording results or other data (such as a form - hard or soft copy) can be considered a document.

The template, once completed, would be considered a record. A record is evidence of activity.
Just to be clear:
"once completed" means with the data from the activity filled in, NOT a completed blank form ready for data to be entered..
 

Jim Wynne

Staff member
Admin
#9
Re: Difference between "Document " and " Record" in ISO Procedure

Records can be corrected or amended - i.e. changed - once completed
I don't think so! A record is the history of the actvity. We don't normally change history, but it may often be amended as new information comes to light.
Well, that's what jkuil said--records can be corrected or amended. Outside of regulated industries where there are explicit rules for record-keeping, the old saw about records never changing is just wrong.
 

Stijloor

Staff member
Super Moderator
#10
Re: Difference between "Document " and " Record" in ISO Procedure

Well, that's what jkuil said--records can be corrected or amended. Outside of regulated industries where there are explicit rules for record-keeping, the old saw about records never changing is just wrong.
I agree. Databases that often are used as "records" are changed as additional information becomes available. For example, a training (records) database is changed when a person receives additional training or when a time based training certificate expires.

Stijloor.
 
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