Difference Between Document and Record

1/30/2020 What is the Difference Between Document Control and Record Control?
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The ISO 9001 quality standard has a number of documentation requirements and specifically calls out
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4.2.3 Control of Documents and 4.2.4 Control of Records. The dictionary may have similar definitions for
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the terms document and record, but within ISO 9001:2008 and quality, they have their own meaning. To
understand the difference, first let’s clarify the difference between documents and records. Sales Marketing
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Documents and records may sound alike but there is a big difference between the two. Documents are
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created by planning what needs to be done and records are created when something is done. Documents
can change and records don’t (must not) change. Finance Policies
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Document: Information used to support an effective and efficient organizational
operation. Security Policies
and Procedures
A document consists of any information you use to run your company. Documents
Manual
originate in the planning phase of the Plan, Do, Check, Act, cycle of the process
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approach.
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Since documents are planning material, they are subject to change (under the Act
Planning Manual
phase) as we obtain more information (Do phase) and compare those informational
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or data records (Check phase) to our original plan. Common examples of (QMS)
quality management system documents include:
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Quality Objectives (Required)
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Internal Audit Schedule
Procedures and Work Instructions (Six Required)
Approved Supplier List
Purchasing Criteria
Customer Requirements
Required ISO 9001:2008 Procedure Documents

The ISO Standard requires a few documents: Quality policy, Quality objectives, Quality Manual, and a
minimum of six procedures. The required ISO procedures are:
Clause 4 Documents (2 procedures)

1) 4.2.3 Document Control
2) 4.2.4 Record Control

Become a pH
Clause 8 CAPA (4 procedures)
Expert
3) 8.2.2 Internal Audit
4) 8.3 Nonconforming Product Control
5) 8.5.2 Corrective Action

Avoid pH measuremen
6) 8.5.3 Preventive Action errors with the free pH
Measurement Theory
Record Definition
Guide
Record: Evidence about a past event.
A record is generated in the “do” phase of PDCA. Records consist of any data you collect during the
operation of your business QMS. Records are facts and should not change. If new facts arise that
contradict the old facts (an error), then you should strike through the old fact and record the new fact.
There are 21 required records within ISO 9001:2008

The ISO Standard requires 21 records with most (14) coming from clause 7 product realization. What are
these 21 records?
Clause 5 Management Responsibility (1 record)

1) 5.6.1 Records from management reviews (minutes, results, actions).
Clause 6 Resource Management (1 record)
2) 6.2.2 (e) Education, training, skills and experience records/files.

Great
Clause 7 Product Realization (14 records) Based on 48 reviews o
3) 7.1 (d) Evidence that the realization processes and resulting product fulfill requirements.
4) 7.2.2 Results of the review of requirements relating to the product and actions arising from the Positive Nega
review.
5) 7.3.2 Design and development inputs.
6) 7.3.4 Results of design and development reviews and any necessary actions. Carmen Valles
January 2
7) 7.3.5 Results of design and development verification and any necessary actions. The Iso 22000 it is helpfu
prepare…
8) 7.3.6 Results of design and development validation and any necessary actions.
Read more
9) 7.3.7 Results of the review of design and development changes and any necessary actions.
10) 7.4.1 Results of supplier evaluations and actions arising from evaluations.
Mark Gage
11) 7.5.2 (d) As required by the company to demonstrate the validation of processes where the December 23
resulting output cannot be verified by subsequent monitoring or measurement. I found this manual
informative and…
12) 7.5.3 The unique identification of the product, where traceability is a requirement. R d
13) 7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use.
14) 7.6 (a) Standards used for calibration or verification of measuring equipment where no
international or national measurement standards exist.
15) 7.6 Validity of previous results when measuring equipment is found not to conform with its
requirements.
16) 7.6 Results of calibration and verification of measuring equipment.
Clause 8 CAPA (5 records)

17) 8.2.2 Internal audit results.
18) 8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority
responsible for the release of the product.
19) 8.3 Nature of the product nonconformities and any subsequent actions taken, including
concessions obtained.
20) 8.5.2 Results of corrective actions.
21) 8.5.3 Results of preventive actions.
Difference Between Document Control and

Record Control
Now, with a better understanding of what documents and records are, we can look closer at what is
required for control of documents (4.2.3) and records (4.2.4). Both ISO clauses require that documents
and records are controlled, but what does that mean?
ISO 4.2.3 Document Control
Documents are created as a part of your organizations planning. Therefore, ISO requires that these
planning documents are approved prior to use to ensure they are adequate (appropriate). Documents
need to be reviewed and updated to ensure the content is accurate. If changes are made to plans then it
is imperative that the changes are identified and communicated to anyone that uses those planning
documents.
Users need legible, up-to-date, and readily available documents to do their job. The bottom line,
documents need to be reviewed, approved, legible, up-to-date, communicated, and readily available.
That is what ISO wants from the control of your documents.
ISO 4.2.4 Record Control

Records are not the plan. Records are created by plans. Records are data, but data is not information.
Data must be converted into information through the use of charting or trend analysis. So the
requirements for records are different. Records need to be identifiable (labeled), stored, protected
(uncorrupted), retrievable (you need to use the data), retained (backed-up), but disposed of when
obsolete.
Documents are created by planning what needs to be done and records are created when something is
done. Documents can change and records don’t change. Documents need to be reviewed, approved,
legible, up-to-date, communicated, and readily available. Records need to be identifiable, stored,
protected, retrievable, retained, but disposed of when obsolete. That is what ISO means by control of
documents and control of records.
Download free ISO 9001 2015 procedures examples from the ISO 9001 Manual now.
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35 Comments
Eira says: Reply
February 4, 2016 at 7:36 pm
Is the record needs to be approved as per document
Chris Anderson says: Reply
Records are not really approved, they are created by the originator as a
record of fact. If you record the temperature outside, on a form, then that
is the temperature you saw on the gauge at the time you read it. Some
events are recorded and then validated that they are effective, like a
corrective action record. But that is not approval. Someone is validating
the the event is complete and the corrective action is effective. The record
itself is not approved.
MARIA says: Reply
December 6, 2016 at 11:10 pm
Yes, Indeed !!
carla. says: Reply
May 31, 2017 at 12:00 pm
Record review and approval is an authentication and

verification process, which is not the same as review and
approval of controlled documents.
bipin k mishra says: Reply
Record we can only review not approve.
March 2, 2016 at 5:12 pm
Basically, records are reviewed and the data is used as

evidence of an event. Documents are like directives and
consists of things like the quality manual, plans, procedures,
or forms and these need to be approved prior to use so that
the people using these documents know they are using the
right versions.
Chris says: Reply
April 28, 2016 at 11:31 am
I would say that sometimes records may be

approved as well because that may be the
requirement of internal procedures.
Let’s have an example: a purchase order is a record

(which documents the fact that someone in the
company wants to purchase some goods) but it is
not vaild until approved by CEO or purchasing
department manager.
Chris Anderson says:

May 4, 2016 at 10:09 am
I would call a purchase order a

document because it can be changed.
Records do not or should not change. A
purchase order is a request. Documents
are approved, records record data of
what has happened in the past. Since the
purchase order has not been filled, it has
not happened and does not record any
data of an event. At any time you can
cancel or revise a purchase order and it
requires approval. Therefor, it is a
document.
Jacinto P. Valera says: Reply
June 15, 2016 at 12:53 am
hello all, i am working in an government

educational institution. How about Memoranda,
Circulars from other government agencies/offices,
are they considered document (at our end), since
they were approved prior to issuance? How about
letters various types of documents from other
offices (letters, notices, travel orders,
certifications…) within the university, can they
become a record in my office?
Chris Anderson says:

July 15, 2016 at 10:44 am
To keep it simple, documents are

approved. Records are signed or
authenticated. In a government,
everything is a record of what was done
while in office. The new ISO 9001:2015
standard eliminates the distinction and
introduces the term “documented
information” which now includes
documents, forms, procedures, records,

work instructions, or anything used by
the organization to demonstrate
effectiveness. Maybe this will simplify it
for everyone…
bipin k mishra says: Reply
How we can fine differentiate to both of them.
Mat says: Reply
July 2, 2016 at 10:23 pm
Some records are approved. A record of compliance should be approved

before sending to Government. Technical reports are records and should
be approved before release. An approval in this case is signing off that
the data is accurate and/or can be released.
An issued or approved purchase order is clearly a company record.

Financial auditors would certainly see it as such.
vaibhav salunke says: Reply
June 25, 2016 at 12:02 am
Is record can help to create a document??
July 15, 2016 at 10:45 am
Usually documents (i.e. forms) are used to create records.
Ephrem KAYUMBA says: Reply
August 4, 2016 at 4:26 am
A Document is a draft that varies ideally. A Record is a done/completed

action unchangeable. What you mean above can happen as referring to
the completed acts to set new plan. By that time you will be drafting. At
its final decision/completion a Document gives birth to a record. Record is
born at document’s completion. Through Record you will set policy for
conservation this happens in temporary view. Finally it becomes an
Archive which pursues permanent policy of conservation. See the:
Document-Record-Archive.
Resha says: Reply
November 23, 2016 at 11:01 pm
Should manufacturer control ranges also be documented?
December 2, 2016 at 11:43 am
Specification limits should be documented but control ranges are a

function of the process. As you improve control over your process they
will narrow. They could be documented in an improvement plan, in work
instructions as expected output, or recorded on a record showing what
the process results were. Many machines today record the output’s in real
time control charts, which are records of the process performance. The
method of documentation depends on your usage.
Dr Sameer V Kodkani says: Reply
If a print out of Electronic Medical record is taken and provided to the patient
without signing on it. Are those papers documents or records ?
A record consists of data that can not be changed. Think of test results or
a medical history. It can be paper or electronic. The signature adds
traceability and improves authenticity, but so does a date on a printout.
The signature may or may not be required.
haneef sheikh says: Reply
January 2, 2017 at 5:17 am
i think if project is still ongoing and activities still

implementing with data that is called document control, and
after complete the project or complete of documents in the
middle of project all that data will become record control
Karen Korwal, Document Control Administrator

Reply
(15 yrs) says:

March 7, 2017 at 9:37 am
Somewhat correct, Haneef — the changeable

documents during a project require document
control. After the project is complete, the
documents become *records* of the project and

then require *records management* (not control).
However, during the project, there can also be

records created, such as measurements, test
results, etc. These types of documents are *records*
— they do not change. Procedures, site plans,
engineering drawings, etc. change many times
throughout a project, and therefore they require
*document control*. The records that are also part
of the project are handled via the document control
system while the project is ongoing, but they are
still records (e.g. the electrical output readings of a
generator on a particular day do not change; they
are not subject to revision. Readings taken on
another day would be a *record* of the output on
*that* day, etc.).
Again, once the project has ended, *all* documents

used on the project become records, as they are no
longer subject to revision. They are records of what
was done on the project.
Hope this helps.
Tissa Mendis says: Reply
January 8, 2017 at 8:00 pm
Thank you so much.This gives a very good definition about what is a document
,what is a record & how the document & record control is done.
rlm says: Reply
May 29, 2017 at 10:35 pm
WHEN DO YOU SAY THE DOCUMENT IS IN A SERIES AND NOT IN REVISION
June 2, 2017 at 8:21 am
I’m not sure the difference you are referring too.
Javed Iqbal says: Reply
October 9, 2017 at 1:09 am
Sir, We wrote a procedure for incoming material and stated that the checked
Quantity to be labeled by putting a sticker containing certain information about the
inspection. Now do we need to put a control number on the sticker? if yes why and
if no then why?
Regards
Javed
October 9, 2017 at 10:46 am
Form documents need to be controlled so it is clear you have the latest

authorized revision of the form. Form records need to be protected from
alteration. A control ID and date should be sufficient.
Mohamed Ismail says: Reply
July 12, 2018 at 2:18 am
it’s mean that record is as documentary operation.. just no more .
Ann says: Reply
April 15, 2019 at 2:30 pm
A situation about controlled documents under ISO 9001:2015 – we are having

issues defining when a form becomes a record and when ‘the most recent version’ is
applied.
The example – when a project is started in our organization, the coordinator takes
the latest controlled form (in this example I’ll call it an inspection checklist),
populates only certain fields in the form and then stores it in a project folder so that
it is available when needed (point of use). The problem lies when the inspection
checklist is completed and made into a record, which can sometime occur after a
new revision has been done to the controlled form (weeks, months and sometimes
years). So, if the form is only partially populated does it become a record? I would
say no because records should not be modified but would like your opinion on that.
Also, if a new version of a controlled form is released, should those partially
populated incomplete documents be redone using the last version? Your thoughts
on solving this dilemma would be most appreciated. Thank you,
April 15, 2019 at 3:10 pm
As soon as you add data to the form it become a record on that date by
that person. What makes it a record is the data, date, and person, not
the paper form. The fact that you add more information to the record on
another date, maybe with a different person is fine, it just makes it a
journal or notebook record. Records can by many things: database,
email, notebook, journal, pictures, video, forms, etc. Now if you change
the form in the middle, just cross out the places in the new form where
previous data was captured and attach the old form/record to it. What
can’t be modified is the data on the record.
Sam says: Reply
April 15, 2019 at 7:07 pm
Sir , We ussualy take Minute of Meeting (MoM) during a formal meeting or any
managemnt meeting in our company and we use the MoM form to capture what
was important during the meeting. after the form is fillid up, shall we call the form
a Record or still a Document ?
April 23, 2019 at 12:07 pm
The form is a document. As soon as you enter any data on the form it
becomes a record.
Mary Brehaut says: Reply
May 9, 2019 at 5:48 pm
I am confused regarding the following example. Is an email that provides financial

or statistical data, or approval of a plan change of direction from a Manager a
record? The final plan will reflect the details contained in the email and so the plan
is a record. However I am unsure as to whether the email would be considered in
the planning (a document) or doing (record) stage, and whether it is a record in
itself? If it is not a record, is its only purpose advice and approval?
May 14, 2019 at 8:49 am
Plans can change, and they do change often, so a plan is always a

document. The approval of a plan is a record of who approved it and
when it was approved. This discussion of documents and records is mute
now that ISO 9001:2015 calls all documents and records “Documented
Information”.
Frank says: Reply
August 12, 2019 at 2:29 am
Hi
Hope you can help.
If a record of results has not been changed only a spelling mistake crossed out fix
up and initial. Does this comply with iso9001-2016?
August 15, 2019 at 9:34 am
ISO 9001 is not specific on how to change documented information, but

7.5.3.2.b control states that “it is adequately protected (e.g. from loss of
confidentiality, improper use, or loss of integrity)” which I read as cross
out, fix up, and initial.
The ISO/IEC 17025 Clause 4.13.2.3, standard does address this, it says:
“When mistakes occur in records, each mistake shall be crossed out, not
erased, made illegible or deleted, and the correct value entered
alongside. All such alterations to records shall be signed or initialed by
the person making the correction. In the case of records stored
electronically, equivalent measures shall be taken to avoid loss or
change of original data.”
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1/30/2020 What is the Difference Between Document Control and Record Control?

Policy Document Free How To Lean ISO

483 Database Manual Rev D | ABR217M

Difference Between a Document and a Record Procedures Manual |

Quality Policy (Required) ISO 9001 2015

Internal Audit Schedule

Procedures and Work Instructions (Six Required)

Approved Supplier List

Required ISO 9001:2008 Procedure Documents

Clause 4 Documents (2 procedures)

2) 4.2.4 Record Control

4) 8.3 Nonconforming Product Control

5) 8.5.2 Corrective Action

There are 21 required records within ISO 9001:2008

Clause 5 Management Responsibility (1 record)

Clause 6 Resource Management (1 record)

2) 6.2.2 (e) Education, training, skills and experience records/files.

5) 7.3.2 Design and development inputs.

16) 7.6 Results of calibration and verification of measuring equipment.

Clause 8 CAPA (5 records)

20) 8.5.2 Results of corrective actions.

21) 8.5.3 Results of preventive actions.

Difference Between Document Control and

ISO 4.2.3 Document Control

ISO 4.2.4 Record Control

More Articles from Bizmanualz...

Eira says: Reply

February 4, 2016 at 7:36 pm

Is the record needs to be approved as per document

Chris Anderson says: Reply

February 8, 2016 at 1:32 pm

MARIA says: Reply

December 6, 2016 at 11:10 pm

carla. says: Reply

May 31, 2017 at 12:00 pm

Record review and approval is an authentication and

bipin k mishra says: Reply

February 19, 2016 at 10:38 pm

Record we can only review not approve.

Chris Anderson says: Reply

March 2, 2016 at 5:12 pm

Basically, records are reviewed and the data is used as

Chris says: Reply

April 28, 2016 at 11:31 am

I would say that sometimes records may be

requirement of internal procedures.

Let’s have an example: a purchase order is a record

Chris Anderson says:

I would call a purchase order a

Jacinto P. Valera says: Reply

June 15, 2016 at 12:53 am

hello all, i am working in an government

Chris Anderson says:

To keep it simple, documents are

documents, forms, procedures, records,

bipin k mishra says: Reply

February 19, 2016 at 10:35 pm

How we can fine differentiate to both of them.

Mat says: Reply

July 2, 2016 at 10:23 pm

Some records are approved. A record of compliance should be approved

An issued or approved purchase order is clearly a company record.

vaibhav salunke says: Reply

June 25, 2016 at 12:02 am

documents become records of the project and

Again, once the project has ended, all documents