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

R

rcm_mech

• Dec 4, 2009

• #1

Hello Friend

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

Thanks in advance.

 

J

jequihua

• Dec 4, 2009

• #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

 

Stijloor

Leader

Super Moderator

• Dec 4, 2009

• #3

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

rcm_mech said:

Hello Friend

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

Thanks in advance.

Click to expand...

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

Stijloor.

 

S

sudwel

• Dec 4, 2009

• #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

• Dec 4, 2009

• #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

• Dec 4, 2009

• #6

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

sudwel said:

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

Click to expand...

Records can be corrected or amended - i.e. changed - once completed

 

Q

QA_chick

• Dec 4, 2009

• #7

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

Stijloor said:

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

Stijloor.

Click to expand...

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

Prophet of Profit

• Dec 4, 2009

• #8

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

jkuil said:

Records can be corrected or amended - i.e. changed - once completed

Click to expand...

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.

QA_chick said:

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.

Click to expand...

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

Leader

Admin

• Dec 4, 2009

• #9

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

jkuil said:

Records can be corrected or amended - i.e. changed - once completed

Click to expand...

Wes Bucey said:

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.

Click to expand...

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

Leader

Super Moderator

• Dec 4, 2009

• #10

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

Jim Wynne said:

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.

Click to expand...

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.