YBS MANUFACTURING (M) SDN. BHD.

YBS MANUFA

ISO9001:2015 LEVEL 2 PROCE

DOCUMENT NUMBER: QMP-02-R0 CONTROL

Revised
Date
NA

CONTROL OF
DOCUMENTED
INFORMATION

DOCUMENT LEVEL 2

EFFECTIVE DATE: 01 JULY 2021

PREPARED APPROVED

MR MANAGING DIRECTOR

Important note: This document is the property of YBS MANUFACTURING(M) SDN.BHD. Any
unauthorised used is strictly prohibited. If you happen to receive this document in error,
please return to the owner or delete from your system.It must not be reproduced in whole
or part or otherwise disclosed without the prior consent in writing from YBS
MANUFACTURING.
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LEVEL 2 PROCEDURE: HISTORY OF CHANGES LEVEL 2 PROCE

CONTROL OF DOCUMENTED INFORMATION CONTROL OF D

Effective Contents of Changes Pg. Pg. Prepared Checked Approved
Date Rev. 1.Purpose
01.07.2021 Initial Issue all 0 MR MD

2. Scope

3. References

4. Definition

5. Abbreviation
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CONTROL OF DOCUMENTED INFORMATION CONTROL OF DO

6. Procedure Outline
To describe a control system where Documented Information are maintained 6.1 Document Control (Internal)
and retained.
Responsibility

This procedure is applied to all documented information that comes under the All Sections
preview of the scope of the Quality Management System either internally generated
or received from external sources.

3. References
3.1 International Standard ISO9001:2015 Requirements Respective Process
3.2 Quality Management System Manual Owners

4. Definition
4.1 Documented Information Maintained
Documents necessary for the company's QMS to function effectively are Managing Director
controlled its approval, issue, changes, distribution and obsoletion.
Effectively known as Quality Documents.
4.2 Documented Information Retained
Documents showing evidence for the effectiveness of the company's
QMS are controlled its identification, indexing, protection, retrieval,
retention and disposition. Effectively known as Quality Records. DC

5. Abbreviation
5.1 QMS Quality Management System
5.2 DC Document Controller
5.3 MR Management Representative
5.4 PIC Person-in-charge Related Sections
5.5 MD Managing Director

Respective Process Owner

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LEVEL 2 PROCEDURE: DETAILS LEVEL 2 PROCEDURE: DETA
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NTROL OF DOCUMENTED INFORMATION CONTROL OF DOCUM

ment Control (Internal) 6.2 Document Control (External)

Responsibility Outline Description Interfaces Responsibility

All Sections MR, DC All Sections

Arise need for
Documentation

All Sections

spective Process MR, DC

Owners Prepare Document "Master List of DC
Quality Documents "

DC

naging Director No DC
Approve? Document Owner DC

Yes

DC Related Sections All Sections

Distribution and recall "Controlled Copy" stamp
obsolete document

elated Sections Use DC

No DC
tive Process Owner Require MR, DC
Changes?

Yes
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2 PROCEDURE: DETAILS LEVEL 2 PROCEDURE: DETAILS
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OL OF DOCUMENTED INFORMATION CONTROL OF DOCUMENTE

ol (External) 6.3 Records Control

Outline Description Interfaces Responsibility Outline Description

Receive Documents from All Sections

External Sources Records in Use

DC
Send to Doc. Controller
DC
Ready for
storage?
" Master List of
Record into Masterlist
Quality Documents"

Stamp "MASTER COPY" "Master Copy" stamp DC Identification, Indexing

and record date Filing

"External Documents" File DC

File Retention Period

DC Storage, Protection,
No Retrieval
Require DC
Distributio
n?

Yes Over
Retention
Period?

Duplicate master copy

and stamp "Controlled Copy" stamp
"CONTROLLED COPY"

Managing Director Approval to

Dispose?
Distribute

Related Section PIC Dispose

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DOCUMENTED INFORMATION CONTROL OF DOCUMENTED INF

7. Procedure Details

7.1 Document Control (Internal)

Outline Description Interfaces 7.1.1 Document Level and Types
7.1.1.1 Level 1 QMS Manual (incorporate Quality P
7.1.1.2 Level 2 Procedure
Records in Use
7.1.1.3 Level 3 Supporting Documents (Operation I
Objectives, External Documents etc
7.1.1.4 Level 4 Forms
No All Sections PIC
Ready for
storage? 7.1.2 Generation of the document and approval
7.1.2.1 Level 1 QMS Manual (incorporate Quality P
Preparer Management Representative(MR)
Yes Approver Managing Director
Identification, Indexing, 7.1.2.2 Level 2 Procedure
Filing Preparer Dept. Head or Management Repres
Approver Managing Director
Control of Records List 7.1.2.3 Level 3 Supporting Documents (except exte
Retention Period
Preparer Respective In-Charge
Checker Dept. Head or Management Repres
Storage, Protection, Quality Record Storage Approver Managing Director
Retrieval 7.1.2.4 Level 4 Forms
Preparer Respective In-Charge

Over No 7.1.3 Numbering System

Retention
Period? 7.1.3.1 Level 1 QMS Manual
Numbering Structure
QM :- Quality Management System Manu
Yes RX :- status of revision, where
R0 :- initial issue
No DC R1 :- first revision and so on.
Approval to Authority for Disposal of For Level 1 Manual: History of Changes page ad
Dispose?
Quality Records as follows:- 2.00(first page), 2.01(second page)

Yes

Dispose Master Document List

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UMENTED INFORMATION CONTROL OF DOCUMENTED INFORM

7.1.3.2 Level 2 Procedure
Numbering Structure QMP-AA-RX
QMP :- Quality Management Procedure
AA:- number of the document, running number star
nual (incorporate Quality Policy) 03 onwards
RX :- status of revision, where
g Documents (Operation Instructions, Quality R0 :- initial issue
s, External Documents etc) R1 :- first revision and so on
For Level 2 Procedure: History of Changes page addition a
numbered as follows:- 2.00 (first page), 2.01(second page
and so on.
nual (incorporate Quality Policy) 7.1.3.3 Level 3 Supporting Documents
ment Representative(MR) Numbering Structure QSD-AA-RX
QSD :- Quality Supporting Documents
AA:- number of the document, running number star
ad or Management Representative(MR) 03 onwards
RX:- status of revision, where
g Documents (except external documents) R0 :- initial issue
e In-Charge R1 :- first revision and so on
ad or Management Representative(MR) For Level 3 Supporting Documents: History of Changes pa
to be numbered as follows:- 2.00(first page), 2.01(second
(third page) and so on.( Where applicable only)
e In-Charge 7.1.3.4 Level 4 Forms
Numbering Structure FM/AAA/XX
FM :- Forms
AAA:- number of the document, running number star
003 onwards
QM-RX XX:- status of revision, where
anagement System Manual 00 :- initial issue
revision, where 01 :- first revision and so on
Numbering Structure may vary by departments own func
revision and so on. 7.1.4 Numbering Control and Distribution
History of Changes page addition are to be numbered 7.1.4.1 All document number designation and distribution shall b
t page), 2.01(second page), 2.02(third page) and so on. the Document Controller(DC).
7.1.4.2 All distribution shall be recorded in the " Distribution List"
7.1.4.3 All distributed copy shall be stamped "Controlled Copy"
7.1.4.4 Those copies that are temporarily released shall be stamp
"Uncontrolled Copy"
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NTED INFORMATION CONTROL OF DOCUMENTED INFORMATIO

7.1.5 Revision of Document
QMP-AA-RX 7.1.5.1 Whenever there arise a need to revise any document, such responsi
nt Procedure shall be entrusted to the preparer of the document as in Clause 7.1 o
ment, running number start from 01,02, Control of Documented Information or to the owner department of
document.
7.1.5.2 No revision of the external document shall be carried out by the com
unilaterally. Such revision can only be done with the consent of the o
of the external document.
of Changes page addition are to be
st page), 2.01(second page),2.02(third page) 7.1.6 Time period for conducting revision
7.1.6.1 All revisions shall be completed within 1 month after retrieve docum
from Document Controller(DC).
QSD-AA-RX 7.1.6.2 However, any inability to meet the above time period shall be notifie
to the Document Controller(DC).
ment, running number start from 01,02,
7.1.7 Page Revision
7.1.7.1 Page revision are allowed when there are minor changes to the docu
However, when a major change is required, it is advised to make a
document revision.
nts: History of Changes page addition are 7.1.7.2 Individual page revision is indicated on the top right corner with the
00(first page), 2.01(second page), 2.02 revision number. The revision number system is as follows:- start wi
applicable only) 01,02,03 and onwards.
In case of document revision, all the pages (each), revision numberin
FM/AAA/XX shall be chamged back to 00.

ment, running number start from 001,002, 7.1.8 Obsoletion and disposal of Document
7.1.8.1 Level 1 QMS Manual
Obsoletion of document is not applicable
7.1.8.2 Level 2 and Level 3
7.1.8.2.1 The approver of the Level 2 and Level 3 document shall d
by departments own functional use. on the obsoletion of the document.
7.1.8.2.2 The Master Copy of the document shall be stamp "Obsole
on and distribution shall be conducted by each page and be kept by the DC at a separate location.
7.1.8.2.3 All of the retrived "Controlled Copy" shall be disposed in
d in the " Distribution List" appropriate manner.
mped "Controlled Copy" 7.1.8.3 Level 4 Forms
rily released shall be stamped 7.1.8.3.1 The originating section of the Level 4 document shall deci
the obsoletion of the document.
7.1.8.3.2 The "Master Copy" of the document shall be stamp"Obso
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NFORMATION CONTROL OF DOCUMENTED INFORMATION

on each page and kept by DC.
y document, such responsibility 7.1.8.3.3 All the balance unused documents shall be scrapped or
document as in Clause 7.1 of otherwise marked by a line across the printed portion and can
the owner department of the be used the reverse side for other purposes.

l be carried out by the company 7.2 External Documents

e with the consent of the owner 7.2.1 Receiving of External Documents and Registration
7.2.1.1 All Sections are responsible to receive any external documents, from
customers and other interested parties.
7.2.1.2 All received External Documents shall be passed to the DC.
month after retrieve document 7.2.1.3 DC shall record into " Master List of Quality Documents"
7.2.1.4 Numbering of document shall follow the number given by the external
time period shall be notified parties.
7.2.1.5 DC shall stamp "Master Copy" at the appropriate position on the document.

7.2.2 Filing and Distribution

minor changes to the document. 7.2.2.1 When no distribution is required, DC shall file the external document into
d, it is advised to make a file "External Documents".
7.2.2.2 When distribution is required, DC shall make copy of the document,
e top right corner with the stamp "Controlled Copy", and distribute to related sections.
tem is as follows:- start with

s (each), revision numbering 7.2.3 Obsoletion and disposal

7.2.3.1 The obsoletion of external documents shall be decided on case by case
basis by MR with consent from Managing Director or the external source.
7.2.3.2 The Master Copy of the document shall be stamp "Obsolete" on each page
and kept by the DC.
7.2.3.3 All the related "Controlled Copy" shall be disposed in appropriate manner.
7.2.3.4 Master Copy disposal shall be at the instruction of the external source.
d Level 3 document shall decide
7.3 Records Control
ent shall be stamp "Obsolete" on 7.3.1 Ready for Storage
DC at a separate location. 7.3.1.1 Forms that are completed filled up with proper authorization are ready
Copy" shall be disposed in for storage.
7.3.1.2 Storage of records shall be conducted by DC.

evel 4 document shall decide on 7.3.2 Identification, Indexing and Filing

7.3.2.1 Indexing shall be decided in accordance with the purpose of records.
ment shall be stamp"Obsolete" (demonstration, traceability, preventive and corrective action etc)
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RMATION CONTROL OF DOCUMENTED INFORMATION

7.3.2.2 The title for indexing of records file shall be written in legible characters
e scrapped or or symbols.
nted portion and can 7.3.2.3 When the same file is used for filing the different types of records, the
filing shall be identified and indexed and the table of contents shall be
prepared for records on each file.
7.3.2.4 Filing shall be decided in accordance with the purpose of record.
Segregation by location,project, process etc.
ocuments, from
7.3.4 Collection
7.3.4.1 DC is responsible to prepare "Control of Records List", it is then reviewed
by MR and finally approved by the Managing Director.
en by the external 7.3.4.2 Each Section PIC are responsible to submit the records to the DC for
storage. Location of storage shall be decided based on the purpose of the
ition on the document. records. MR or Managing Director has the authority to decide the location.

7.3.5 Storage
ernal document into 7.3.5.1 Basically records shall be stored in the file, cabinet or carton. The file,
cabinet or carton shall be located in a fixed place with clear indications.
the document, 7.3.5.2 When records are stored in the carton box, the name of the records, the
duration and responsible person's name shall be indicated on the outside
of the boxes. Due date for disposal shall be pre determined.
7.3.5.3 Records could also be store in softcopy.

ed on case by case 7.3.6 Maintenance, Retrieval/Accessibility

the external source. 7.3.6.1 The storage shall be maintained in a good condition by DC or Section PIC.
bsolete" on each page 7.3.6.2 The records shall be stored in the suitable environment to minimize
deterioration, damage and to prevent loss.
appropriate manner. 7.3.6.3 Records shall be made available for access by each responsible person and
e external source. maintain in facilities for easy retrieval.

7.3.7 Disposition
7.3.7.1 Records, which are over the retention period shall be disposed in
orization are ready reviewing storage condition, either by reuse, tear,shred etc.
7.3.7.2 Records could also be disposed once the records have been scanned and
save into rewritable compact discs(CD-RW). The files of records in the
CD-RW will only be deleted when the retention period is over.
7.3.7.3 The retention periods of records shall be defined in the " Master
pose of records. Document List". However that the stated retention period is the minimum
ve action etc) requirement to keep and the records may be stored more than the
 retention period.
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CONTROL OF DOCUMENTED INFORMATION CONTROL O

7.3.7.4 Any disposal of records shall be confirmed by MR and approve by the 8. Forms related to this P
Managing Director.

7.3.8 Revision of Retention Period and disposal method

7.3.8.1 MR shall review the retention period and disposal method and recommend
changes if required. Recommend to the Managing Director.

7.3.9 Distribution of records as requested

7.3.9.1 All distribution of records(copy) shall be stamped "Uncontrolled Copy"
7.3.9.2 When required by Customer's or interested parties, such records shall
be made available and customers shall be contacted regarding disposition
of their records.

7.3.10 Reuse of Records

7.3.10.1 DC is responsible to ensure all reuse paper of records shall have an
identification such as cross mark on the used side.

7.3.11 Electronic Data

7.3.11.1 The data medium(electronic storage) shall be properly stored in a correct
environment to prevent from damage, corruption and failure for future
retrieval.
7.3.11.2 All data medium and master list are updated after each new files are
created or cleared.
7.3.11.3 All data medium shall have a back-up and a recovery system shall be
maintained.
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CONTROL OF DOCUMENTED INFORMATION

8. Forms related to this Procedure

Master List of Quality Documents FM/004/XX

Document Distribution List FM/005/XX
Control of Records List FM/006/XX
Quality Record Storage FM/007/XX
Authority for Disposal of Quality Records FM/008/XX
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