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 Pg.
Date Contents of Changes Pg. Rev. Prepared Checked Approved
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

To describe a control system where Documented Information are maintained

and retained.

This procedure is applied to all documented information that comes under the
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
3.2 Quality Management System Manual

4. Definition
4.1 Documented Information Maintained
Documents necessary for the company's QMS to function effectively are
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.

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

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CONTROL OF DOCUMENTED INFORMATION

6. Procedure Outline
6.1 Document Control (Internal)

Responsibility Outline Description Interfaces

All Sections MR, DC

Arise need for
Documentation

Respective Process MR, DC

Owners Prepare Document "Master List of
Quality Documents "

Managing Director No DC
Approve? Document Owner

Yes

DC Related Sections
Distribution and recall "Controlled Copy" stamp
obsolete document

Related Sections Use

No
Respective Process Owner Require MR, DC
Changes?

Yes

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6.2 Document Control (External)

Responsibility Outline Description Interfaces

All Sections Receive Documents from

External Sources

All Sections DC
Send to Doc. Controller

DC " Master List of

Record into Masterlist
Quality Documents"

DC Stamp "MASTER COPY" "Master Copy" stamp

and record date

DC "External Documents" File

File

No
All Sections Require DC
Distributio
n?

Yes

Duplicate master copy

DC and stamp "Controlled Copy" stamp
"CONTROLLED COPY"

DC
Distribute

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6.3 Records Control

Responsibility Outline Description Interfaces

All Sections
Records in Use

DC No All Sections PIC

Ready for
storage?

Yes
DC Identification, Indexing,
Filing

DC Control of Records List

Retention Period

DC Storage, Protection, Quality Record Storage

Retrieval

Over No
Retention
Period?

Yes

No DC
Managing Director Approval to Authority for Disposal of
Dispose?
Quality Records

Yes

Related Section PIC Dispose Master Document List

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7. Procedure Details

7.1 Document Control (Internal)

7.1.1 Document Level and Types
7.1.1.1 Level 1 QMS Manual (incorporate Quality Policy)
7.1.1.2 Level 2 Procedure
7.1.1.3 Level 3 Supporting Documents (Operation Instructions, Quality
Objectives, External Documents etc)
7.1.1.4 Level 4 Forms

7.1.2 Generation of the document and approval

7.1.2.1 Level 1 QMS Manual (incorporate Quality Policy)
Preparer Management Representative(MR)
Approver Managing Director
7.1.2.2 Level 2 Procedure
Preparer Dept. Head or Management Representative(MR)
Approver Managing Director
7.1.2.3 Level 3 Supporting Documents (except external documents)
Preparer Respective In-Charge
Checker Dept. Head or Management Representative(MR)
Approver Managing Director
7.1.2.4 Level 4 Forms
Preparer Respective In-Charge

7.1.3 Numbering System

7.1.3.1 Level 1 QMS Manual
Numbering Structure QM-RX
QM :- Quality Management System Manual
RX :- status of revision, where
R0 :- initial issue
R1 :- first revision and so on.
For Level 1 Manual: History of Changes page addition are to be numbered
as follows:- 2.00(first page), 2.01(second page), 2.02(third page) and so on.

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7.1.3.2 Level 2 Procedure
Numbering Structure QMP-AA-RX
QMP :- Quality Management Procedure
AA:- number of the document, running number start from 01,02,
03 onwards
RX :- status of revision, where
R0 :- initial issue
R1 :- first revision and so on
For Level 2 Procedure: History of Changes page addition are to be
numbered as follows:- 2.00 (first page), 2.01(second page),2.02(third page)
and so on.
7.1.3.3 Level 3 Supporting Documents
Numbering Structure QSD-AA-RX
QSD :- Quality Supporting Documents
AA:- number of the document, running number start from 01,02,
03 onwards
RX:- status of revision, where
R0 :- initial issue
R1 :- first revision and so on
For Level 3 Supporting Documents: History of Changes page addition are
to be numbered as follows:- 2.00(first page), 2.01(second page), 2.02
(third page) and so on.( Where applicable only)
7.1.3.4 Level 4 Forms
Numbering Structure FM/AAA/XX
FM :- Forms
AAA:- number of the document, running number start from 001,002,
003 onwards
XX:- status of revision, where
00 :- initial issue
01 :- first revision and so on
Numbering Structure may vary by departments own functional use.
7.1.4 Numbering Control and Distribution
7.1.4.1 All document number designation and distribution shall be conducted by
) 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 stamped
"Uncontrolled Copy"

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7.1.5 Revision of Document
7.1.5.1 Whenever there arise a need to revise any document, such responsibility
shall be entrusted to the preparer of the document as in Clause 7.1 of
Control of Documented Information or to the owner department of the
document.
7.1.5.2 No revision of the external document shall be carried out by the company
unilaterally. Such revision can only be done with the consent of the owner
of the external document.

7.1.6 Time period for conducting revision

7.1.6.1 All revisions shall be completed within 1 month after retrieve document
from Document Controller(DC).
7.1.6.2 However, any inability to meet the above time period shall be notified
to the Document Controller(DC).

7.1.7 Page Revision

7.1.7.1 Page revision are allowed when there are minor changes to the document.
However, when a major change is required, it is advised to make a
document revision.
7.1.7.2 Individual page revision is indicated on the top right corner with the
revision number. The revision number system is as follows:- start with
01,02,03 and onwards.
In case of document revision, all the pages (each), revision numbering
shall be chamged back to 00.

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 decide
on the obsoletion of the document.
7.1.8.2.2 The Master Copy of the document shall be stamp "Obsolete" on
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
appropriate manner.
7.1.8.3 Level 4 Forms
7.1.8.3.1 The originating section of the Level 4 document shall decide on
the obsoletion of the document.
7.1.8.3.2 The "Master Copy" of the document shall be stamp"Obsolete"

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on each page and kept by DC.
7.1.8.3.3 All the balance unused documents shall be scrapped or
otherwise marked by a line across the printed portion and can
be used the reverse side for other purposes.

7.2 External Documents or Customer Document

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.
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
parties.
7.2.1.5 DC shall stamp "Master Copy" at the appropriate position on the document.

7.2.2 Filing and Distribution

7.2.2.1 When no distribution is required, DC shall file the external document into
file "External Documents".
7.2.2.2 When distribution is required, DC shall make copy of the document,
stamp "Controlled Copy", and distribute to related sections.

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.

7.3 Records Control

7.3.1 Ready for Storage
7.3.1.1 Forms that are completed filled up with proper authorization are ready
for storage.
7.3.1.2 Storage of records shall be conducted by DC.

7.3.2 Identification, Indexing and Filing

7.3.2.1 Indexing shall be decided in accordance with the purpose of records.
(demonstration, traceability, preventive and corrective action etc)

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7.3.2.2 The title for indexing of records file shall be written in legible characters
or symbols.
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 7.3.8
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.
7.3.9
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.
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
records. MR or Managing Director has the authority to decide the location. 7.3.10

7.3.5 Storage
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. 7.3.11
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.

7.3.6 Maintenance, Retrieval/Accessibility

7.3.6.1 The storage shall be maintained in a good condition by DC or Section PIC.
7.3.6.2 The records shall be stored in the suitable environment to minimize
deterioration, damage and to prevent loss.
7.3.6.3 Records shall be made available for access by each responsible person and
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
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
Document List". However that the stated retention period is the minimum
requirement to keep and the records may be stored more than the
retention period.
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7.3.7.4 Any disposal of records shall be confirmed by MR and approve by the 8. Forms related to this Procedur
Managing Director.
8.1
Revision of Retention Period and disposal method 8.2
7.3.8.1 MR shall review the retention period and disposal method and recommend 8.3
changes if required. Recommend to the Managing Director. 8.4
8.5
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.

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.

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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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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