Company ABC

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QUALITY MANUAL
ISO 9001

Prepared By : Reviewed By : Approved By

.......................................... ......................................... ............................................

Title : Title :
Title :

Name : Name : Name :

Distribution Controlled
COPY NO NAME OF RECIPIENT
Company ABC
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REVISION RECORD

REV NO PAGE NO DETAILS REVISED APPROVED DATE

BY BY
Company ABC
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ITEM NO CONTENT PAGE NO

1.1 Company Profile
1.2 Company Structure
1.3 Our Customers
2.1 Quality Policy
2.2 Quality Objectives
2.3 Strategies
2.4 Scope of the Quality Management
Systems
2.5 Business Process Sequence and
Interaction
2.6 Outsource Processes
2.7 Exclusion
2.8 QMS Steering Committee
4.1 General Requirements
4.2 Documentation Requirements
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Quality Management System Planning
5.5 Responsibility,Authority And
Communication
5.6 Management Review
6.1 Provision Of Resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
7.1 Planning of Product Realization
7.2 Customer Related Processes
7.3 Design And Development
7.4 Purchasing
7.5 Product And Service Provision
7.6 Control of Monitoring And Measuring
Devices
8.1 General
8.2 Monitoring And Measurement
8.3 Control of Non-Conforming Product
8.4 Analysis Of Data
8.5 Improvement
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1.1 Company Profile

Incorporated in year 1994, Company ABC currently is a specialist in manufacturing
printed paper.

With a workforce of 20, ABC presently occupies premises at Lot 1234, North West of
Malaysia. It’s steady growth backed by the precision forming machinery and
technology coupled with consistent quality control always fulfill customers’
satisfaction through total quality management.

The organization is committed to continual improve performance with measurable

progress and inculcate a quality culture. These are also reflected in our recent
undertaking to seek certification of the internationally recognized ISO 9001Quality
Management System.

1.2 Company Structure

a) Please refer to Appendix A for Organization Chart.
b) Please refer to Appendix B for Quality Management System (QMS) Steering
Committee Chart.
c) Please refer to Employees’ Job Responsibilities file.

2.1 Quality Policy

Our Policy:-
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“Company ABC is highly committed to excel as a world class paper manufacturer

with emphasis on fulfilling customer’s requirements through the continuous
implementation of an effective quality management system and incorporation of
continual improvement process.”

In order to achieve the policy,

1. Quality Objectives shall be established at relevant functions and their

performances are annually reviewed.

2. Quality problems arising in various areas are identified promptly, efficiently and
technically overcome and in economical manner.

3. Any actions employed are to be kept continuously and technically improved as

necessary.

4. Upkeep the Competency and skill of our personnel through various training
development in management, quality and technical.

Authorized by,
Company ABC

…………………………………………………
(Managing Director)

2.2 Quality Objectives

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Quality Monitory
Target Processes/Function
Objectives method

1. Billing accuracy > 90% Monthly Sales

2. Employees’ skill/knowledge level > 70% Monthly Admin

1. Customer complaints <3 Yearly QC

case/year
2. Customer satisfaction index > 85% Yearly Sales & Marketing
3. Product delivery 98% Monthly Sales & Delivery
4. Quotation submission 1 week / Yearly Sales & Marketing
< 50 Cases

1. Product reject rate <= 2.5% Monthly Production

2. Stock Rotation <= 90 Days Monthly Production
3. Response time to breakdown <= 50 hours Monthly Production

Figure 2.2 Table of Quality Objectives

2.3 Strategies
Company ABC shall apply following strategies in order to successfully implement the
Quality Policy and Quality Objectives:-
Ensure the policy is understood by
 shall assure that every employee in the Organization understood and clear in mind
the Quality Policy and Quality Objective by displaying at prominent location.
 shall fully utilize the function of notice board. Any information, announcement,
memorandum and notice shall be placed on the notice board. The related
personnel shall make sure the information on the notice board is always up-to-
date.

Ensure the policy is implemented, shall

 approve the Quality Policy and Quality Objective and ensure it is measurable
precise and correct during the first release.
 focus on continual quality improvement.
 strive for zero defect.

Ensure the policy is maintained, shall

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 carry out Management Review regularly to ensure that the Quality Policy and
Quality Objective are achieved.
 carry out Internal Audit and necessary training periodically to enforce the quality
management.
 promote employees’ motivation, employees’ safety, health and general needs as
an important issue.

2.4 Scope of the Quality Management System

The Quality Management System described within this manual establishes Company
ABC quality assured management system. Scope of Certification under this Quality
Management System is:-

Manufacture and Distribution of Printed Paper

Premise address:-

Malaysia

2.5 Business Process sequence and interaction

Please refer to Appendix C for Business Process Mapping.

2.6 Outsource Processes

has out-sourced one of manufacturing processes as below :
 Printed Paper ‘A’

This out-source process is being controlled through incoming inspection, monitoring

the supplier performance and supplier audit.
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2.7 Exclusion

This Quality Manual as written addresses all the requirements of ISO 9001 except for the
exclusion shown, with justification, in the table below:-

ISO 9001
Clause Exclusion Element Justification
7.3 Design and Development As does not involve in the product design
and development.
All the products are manufactured based
on customer’s requirements defined in
the drawing or specifications or sample
provided by customer.

Figure 3.0 Table of Exclusion Element

2.8 QMS Steering Committee

The Top Management has established a steering committee for the development and
implementation of the Quality Management System. The steering committee comprises of:-

No. Designation
1 Managing Director
2 Factory Manager (Management Representative)
3 Production Manager
4 Administration Manager
5 Accounts Executive
6 QC Head
7 Store Head

Figure 5.1 Table of Steering Committee Members

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4.1 General Requirements

Company ABC shall establish, document and maintain Quality Management System
and continually improve to achieve compliance with ISO 9001 standard.

shall:-
a) Identify entire processes needed for the Quality Management System and their
applications throughout the Organization by the Organizational Chart (Appendix
A) and Business Process Mapping (Appendix c).
b) Make use of Business Process Mapping to illustrate the order and interaction of
processes with the functional departments. The order and interaction of specific
Quality Management System processes can be found on flow charts as well as
operation procedures.
c) Ensure the availability of resources and information needed to support the
operation and monitoring of the Quality Management System processes.
d) Monitor, measure and analyze the Quality Management System processes.
e) Implement actions necessary to achieve planned result and continual
improvement of the Quality Management System processes.

4.2 Documentation Requirements

4.2.1 General
The documentation structure for Quality Management System is as below:

Level I Quality
Manual

Level II Procedures

Level III Work

Instructions/Specification

Level IV
Quality Records

Figure 4.2.1 QMS Documentation Structure

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a) Level I, A Quality Manual

Company ABC defines its Quality and associated policies in accordance

with ISO 9001 standard in the Quality Manual. Therefore, this Quality
Manual acting as a signpost document in the Organization. The Quality
Manual presents a description of the interaction between the processes of
the Quality Management System via illustrating and defining the
following:-
 Quality Policy, Quality Objective
 Organizational structure, job responsibilities and authorities
 Any references applicable to Standard Operating Procedures

Managing Director shall approve the Quality Manual before release for
official uses. Any amendment made shall be approved by the Managing
Director and recorded in the revision history.

The master copy of the Quality Manual shall be kept at the Document
Control Centre and controlled copies shall be distributed to the related
personnel in accordance with Document Control Procedure.

b) Level II, Procedure

The Procedures shall describe and illustrate how the specify Quality
Policy and Quality Objectives are achieved. It works as the associated
supporting procedures to define the Quality Management System within
the Organization. It also explains how implementation of the
requirements of ISO 9001 in accordance with Quality Policy.

c) Level III, Work Instructions/Specification

Documented Work Instructions for production operation are referenced in

Procedures and defined in detail on how a specific activity is performed.

d) Level IV, Quality Records

Quality Records are result of activities needed by the organization to

provide effective implementation of processes. All the Quality Records
shall be kept for the retention period as defined in the Quality Record.
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4.2.2 Control of Documents

The purpose of Control of Documents is to ensure the documents are of the
latest approved revision and made available at the point of use. The approved
and updated documents shall be kept and remained legible, readily identified
and retrievable at the designated location, Any outdated, obsolete and
incorrect information or documentations shall be disposed or marked to
prevent unintended use to those obsolete documents retained for reference.

Any changes or revisions made shall be reviewed and approved by the same
authority person who reviewed and approved the original document. A
Document Change Notice Form shall be filled by the staff who proposed a
change or revision submitted Document Control Center. The staff shall
provide all pertinent background information or justification for the authority
to base their review and approval of the changes. The nature of the change
shall be identified in the document or the appropriate attachments as well.

The Account Executive shall responsible to maintain a master copy of

documentations in hardcopy and electronic originals as well.

A Control of Document Procedure has been prepared to ensure that all the
documents and important sources are controlled and maintained accordingly.

Refer to Document Control Procedure.

4.2.3 Control of Records

The purpose of Control of Records is to retain all the records as documentary

evidence of the Organization to demonstrate conformance and effectiveness
of the Quality Management System.

The Head of Department shall responsible to provide a save place for keeping
the Quality Records that prevent from lost and damage. The Quality Records
shall only be destroyed after the specified retention period. The respective
departments shall determine the retention period of the records under its
charge according to customer, regulatory or requirements as appropriate.

A list of records shall be prepared to identify types of records, coding, location

and the retention period and the staff responsible for maintaining them.
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A Control of Records Procedure has been prepared to ensure that all the
records are kept, arranged and placed accordingly at the desired placed.

Refer to Quality Records Control Procedure.

5.1 Management Commitment

The Top Management and all the staffs of Company ABC are totally committed to the
development, implementation and the maintenance of the Quality Management
System described herein to manufacture high quality products to all the customers.

The Top Management also dedicated to ensure utmost safety conditions for all the
workers, staffs, suppliers, customers as well as the members of public in compliance
to all application legislative or code of practices.

5.2 Customer Focus

The Top Management assures that all customers’ needs and expectations will be
transformed into clear requirements through the requirements described in clauses 7.2
(Customer Related Processes) and 8.2.1 (Customer Satisfaction) in this Quality
Manual.

Through the policy, objectives and processes as illustrated in this Quality Manual, the
Top Management shall provide a desirable environment to consistently fulfill the
customers’ needs and attempt to go beyond their expectations. The top management
optimizes the likelihood of continual achievement through continuos assessment of
customer satisfaction.

5.3 Quality Policy

Please refer to Quality Manual (Clause 2.1).

5.4 Quality Management System Planning

5.4.1 Quality Objectives

Please refer to Quality Manual (Clause 2.2)

5.4.2 Quality Management System Planning

The Top Management has drawn a Quality Management System Plan to be
carried out in order to meet the requirements of ISO 9001 and the Quality
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Objectives and Policy of the Organization. The Quality Management System

Plan shall:-
a) Define how quality is maintained on a specific process or product based on
company’s requirements.
b) Ensures the integrity of the Quality Management System is maintained as
any changes occur.
c) Specify the facilities required, the methods, parameters measured,
sampling plan, frequency and resources used to ensure quality is
maintained at all stages of production processes.
d) Ensure compatibility of the production, installation, inspection and test
procedures and applicable documentation.
e) Identify, review and develop calibration and maintenance techniques as
appropriate
f) Identify control, resource and skill necessary to achieve required quality.
g) Update quality control, inspection and testing techniques as necessary.
h) Identify necessary quality records

The Quality Management System Plan shall be revised as necessary to ensure

its suitability and effectiveness.

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and Authority

The Organization Chart shows the key positions in the Organization and
describes their line of reporting. Every Department Head shall responsible to
disseminate the Organization’s System to the sub-ordinates. The detailed job
descriptions of each position are defined in Company ABC Employees’ Job
Responsibilities File.

5.5.2 Management Representative

The Top Management of Company ABC hereby appointed Factory Manager

as Management Representative. The Management Representative together
with the steering committees shall responsible for the successful development,
implementation and maintenance of the entire stages of Quality Management
System to ISO 9001 which covered in this Quality Manual.

In the absence of the Factor Manager, Administrative Manager will act as the
Management Representation. Within this role, the Management
Representative shall be responsible and authorized for the following:-
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 To liaise with external party on matters relating to Company ABC

Quality Management System.
 To coordinate with the steering committee in order to develop and
implement the Quality Management System that meets the ISO 9001
standard.
 To monitor the effectiveness of the corrective and/or preventive actions
taken.
 To report directly to Managing Director on all the matters pertaining to
Quality Management System adopted by the COMPANY ABC.

5.5.3 Internal Communication

The Top Management of COMPANY ABC shall provide an effective
communication is established throughout the Organization. The
communication channels can be set up through meetings, briefings, training
session, memorandum and notice boards.

5.6 Management Review

5.6.1 General
The Quality Management System of COMPANY ABC will be reviewed of
minimum once per year by the QMS Steering Committee (Clause 2.8) to
ensure its continuing suitability, adequacy and the effectiveness in satisfying
the requirements of ISO 9001 and COMPANY ABC stated quality policy and
quality objectives.

5.6.2 Review Input

The following review inputs shall be extensively discussed during the
Management Review Meeting. The Department shall responsible for the data
collection or preparing the necessary information for discussion.

Review Inputs shall include the following, but not limited to

Follow-up Actions From Previous Management Review Meeting

Internal and/or External QMS Audit Results
Customer Complaints and Feedback
Corrective and Preventive Actions Status
Process Performance, Product Conformity
Any Major Changes of QMS
Improvement Activities
Other Issues As Decided By MD

5.6.3 Review Output

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A Management Review Output in form of Meeting Minutes shall be prepared

after the meeting. The Outputs shall include decisions and actions related to
improvement of the effectiveness of the Quality Management System and its
processes, improvements of the product related to customer requirements and
resource needs. Minutes of the Management Review Meeting are filled and
maintained in accordance with quality records procedures. The record shall
show evidence of how the review was conducted, who was involved, factors
were considered, what conclusions were reached and what actions were taken.
A documented procedure for Management Review has been established.

Refer to Management Review Procedure.

6.1 Provision of Resources

COMPANY ABC shall determine and provide the resources needed to implement,
improve the processes of the Quality Management System and also to address
customer’s satisfaction.

All resources required in the operation of COMPANY ABC are reflected and
determined during the Management Review of Quality Management System, Internal
Audit, New Product Introduction and Training Needs Analysis as well. As for
material resources required, these information defers from one project to another,
therefore, it will be reflected in the individual project quality plan.

6.2 Human Resources

6.2.1 General
COMPANY ABC shall ensure all the employees whom performing activities
that affecting the quality of products are adequately trained. All the employees
are provided training which appropriate to their level of skill and beneficial to
their job performance. They shall able to demonstrate a satisfactory level of
skill and knowledge before engaging in Production, Purchasing, Maintenance,
Storage and Inspection works.

6.2.2 Competence, Awareness and Training

COMPANY ABC shall identify competency needed, establish and maintain

employees’ awareness of these requirements and train personnel as necessary
to continually meet and achieve customer requirements.
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A job description for all positions in COMPANY ABC are prepared to serve
as an organizational aid to identify experience and/or education requirements,
appropriate delegation of responsibilities and coordination of work.

All new employees shall undergo an Orientation Program which shall include
instructions and explanations on COMPANY ABC’s Quality Policy and
Quality Management System. An in-house on-the-job training shall be offered
to those new employees before being placed in their respective areas.

All functions that required skills, absence of which would adversely affect
quality, shall be identified and documented by respective Department Heads.
In this aspect, every Department Heads shall review the level of competence
of employees within their department and identify additional training required.
Administration manager shall gather the necessary information or training
needs from the each Department Heads to draw up an Annual Training Plan.
All of the training records shall be maintained according to procedure control
of records.

Necessary training shall be offered from time to time to the potential

employees in accordance with Training Procedure.
6.3 Infrastructure

COMPANY ABC has determined and provided the infrastructure needed to the
employees which including workspace, equipments and any supporting hardware and
software to achieve conformity to specifications.

A record for all the machinery and tools required shall be prepared and updated every
time a new machine or tools is purchased in order to record the latest status of the
machines. A procedure has prepared for preventive maintenance.

Refer to Preventive Maintenance Procedure.

6.4 Work Environment

COMPANY ABC shall ensure that appropriate work environment is provided. The
considerations shall include, but not limited to:-
a) Cleanliness of workplace
b) Health and safety conditions
c) Work and handling methods
d) Adequate light at inspection areas
e) Ambient working conditions
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7.1 Planning of Product Realization

COMPANY ABC shall plan and establish the processes needed for product
realization. Planning of product realization shall refer to product quality plan and
procedures. In the process of product realization planning, COMPANY ABC shall
determine the following, as appropriate:-
a) Quality objectives and products requirements
b) The need to establish processes, documents and provide resources specific to the
product.
c) The required verification, validation monitoring, inspection and test activities
specific to the product and criteria for acceptance
d) Any records necessary to provide confidence of conformity of the processes and
resulting products.
Refer to Quality Control Plan.

7.2 Customer Related Processes

7.2.1 Determination of Requirements related to the Product

At the initial stage, customer requirements shall be determined and agreed by
both parties of sales and/or marketing personnel and the customer. Before the
acceptance of customer contract and/or during the customer enquiry, quotation
and order acceptance stages, COMPANY ABC shall take account of, but not
limited to:-
 Product requirements specified by customers
 Product requirements not specified by the customers but are necessary for
its intended use.
 Product availability
 Product delivery and post-delivery activities
 Any obligation related to the product, including regularly requirements

7.2.2 Review of Requirements related to the Product

COMPANY ABC shall review the requirements related to the product prior to
the submission of a quotation or order acceptance. The sales and/or marketing
personnel shall carry out a formal review to ensure:-
 The customer’s requirements for the product are clearly defined, agreed
by both parties and documented
 COMPANY ABC has the ability to meet the defined requirements
 The contract or order requirements differing from the previously
expressed are resolved, where applicable
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The result of the customer’s requirements review shall be documented and

kept as record. When any amendment regarding the product requirements is
submitted by customer, COMPANY ABC shall review against the original
order.
Please refer to Contract Review Control Procedure.

7.2.3 Customer Communication

The first contact plays a very essential role in building up a good image in
customer’s observation. Subsequently, the following communication shall
maintain the first impression and continually strengthen the relationship
between COMPANY ABC and customer. Thus, COMPANY ABC shall
establish and implement an effective and efficient communication
arrangement with the customers in relation to product information, enquiries,
contract or order handling, customer feedback and complaints and so on.

The Sales & Marketing is fully responsible in either communicating with the
existing customers or exerts a pull on attracting any potential customers. The
related personnel shall monitor and maintain the customer satisfaction
effectively. All the complaints and feedbacks from the customer shall be
handled through customer survey and information gathered shall be analyzed
followed by the corrective action. For reference of Customer Survey, please
refer to Customer Complaints And Satisfaction Survey Procedure.

7.3 Design and Development

This clause has been excluded. Please refer to Quality Manual Clause 2.7 for
exclusion and justification.

7.4 Purchasing
7.4.1 Purchasing Processes
The procurement of raw material, child parts, packaging material as well as
services are under controlled in order to ensure conformance to specified
requirements which in turn contribute significantly to the quality and
reliability of the finished products. COMPANY ABC shall assess all the
suppliers’ or vendors’ capabilities and performance according to quality
requirements.
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COMPANY ABC has adopted several methods to ensure the purchased items
are conforming to the requirements:-
a) Evaluation and Qualification of new supplier or new vendor
COMPANY ABC employs an evaluation and qualification method to
observe the performance of supplier or vendor in order to make sure the
supplier or vendor is able to meet the procurement requirements.

b) Assessment of the existing suppliers or vendors

As for existing suppliers or vendors whom appeared in the Approved
Supplier/Vendor List, COMPANY ABC will carry out an assessment to
their products and services as well. The Admin Assistant/Purchaser shall
carry the assessment in accordance with the Purchasing Procedure.
Methods of assessment may include, but not limited to:-
 Quality inspection of supplier’s products or vendor’s services
 Records of previous demonstrated quality, capability or performance
 Commercial consideration and delivery performance

c) An efficient purchasing procedure

A purchasing procedure shall be referred to act as a guideline for those
relevant personnel when sourcing for material or services. An Approved
Supplier/Vendor List shall be prepared and updated from time to time.
Please refer to Purchasing Procedure.

7.4.2 Purchasing Information

All the purchases of direct materials shall be made from COMPANY ABC
approved suppliers as listed in the Approved Supplier List. The purchasing
documents shall state the descriptions of the item to be purchased or the
services request as to the following whenever applicable:-
 The type, class, style, grade or the other precise identification
 The title, serial number and issue of the Quality Management System
specification to be applied to the item purchase.
 Quality standard or specifications, where applicable, shall be referred to
without ambiguity. These might includes drawings, process requirements
for approval or qualification of product, procedures, process equipment
and personnel and relevant technical data.

The purchase information shall be reviewed and approved by Managing

Director prior the issuance of Purchase Order.

7.4.3 Verification of Purchased Product

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All the purchased items or services shall be verified upon according to the
Inspection and Testing procedure to ensure the purchased items or services are
conform to specified purchase requirements at source in addition to relevant
inspection and/or test. Any incoming shall pass the inspection and test before
transfer it for the use of production. Any item rejected for non-conformance
shall be recorded and return to the supplier.

COMPANY ABC shall provide facilities to verify that the purchase items or
services are conform to requirements either at COMPANY ABC or at the
customer’s premises prior to delivery. The verification by customer shall not
absolve COMPANY ABC of the responsibility to provide an acceptable
finished product to the customer, nor shall it prelude the right of customer to
reject and return the product later if found to be unacceptable. The
arrangement, verification and release of such product shall determine by
purchasing personnel, and will be recorded on or referenced by the Purchase
Order.
Refer to Inspection And Testing Procedure.

7.5 Production And Service Provision

7.5.1 Control of Production

COMPANY ABC shall plan and control its manufacturing processes in order
to ensure that the required standard of quality is achieved. All the
manufacturing processes as well as the operations shall be documented in the
Procedures which might include Work Instructions, Samples or any other
appropriate documents.

The Production Schedule shall be prepared by Production manager and

approved by the Factory Manager and provide copies of the same to Managing
Director, Store Section, QC Section and Marketing and Sales Department. It
shall take into consideration of the existing stock, material, machinery and/or
equipments and manpower capability. All the amendments in the Production
Schedule shall be checked, reviewed and approved by the Factory Manager.

The Managing Director, Factory Manager and Production Manager are

responsible to ensure:-
a) All the production equipments and tools are adequate and suitable for the
production use.
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b) All the production equipments and tools are functioning correctly and
being maintained from time to time to ensure continuity of the process
capability. All the maintenance shall be kept in the Maintenance Record.
c) All the production workers are well trained for their tasks.
d) Accurate information is provided to related personnel in which specify
product characteristics, processing requirements and verification criteria
as appropriate.
e) Production operations are conducted and controlled in accordance with
Procedure.
f) Production monitoring shall be carried out to ensure the requirements for
the products are met at each stage of manufacture, while monitoring
processes conform to the continuing ability of each process to satisfy its
intended purpose.

Production Manager shall monitor and measure their working processes

accordingly to ensure that their processes remain under control and continue to
produce quality product.

Refer to Manufacturing Process Procedure.

7.5.2 Validation of Processes for Production

COMPANY ABC shall validate any processes for production where the
resulting output cannot be verified by subsequent monitoring or measurement.
The special process that applies to COMPANY ABC is heat treatment.
COMPANY ABC shall establish control on this special processes through the
following methods, as applicable:-
 Define criteria for review and approval of the processes
 Approval of equipment and qualification of personnel
 Use of specific methods and procedures
 Requirements for records
 Re-validation

7.5.3 Identification and Traceability

COMPANY ABC has established a mechanism for product identification and

traceability at materials receiving, production stage and finished products.
Methods used for these identification and traceability processes are essential in
the event of:-
 Product mixing
 Product recall due to batch / product failure or other reasons
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All the incoming materials and child parts shall be identified by packing
documents, tags, labels, markings, stamps and/or other mean of identification.
Once received items are accepted , they shall be moved to appropriate storage
location to ensure that the identification is maintained.

Identification of the product throughout the production processes shall ensure

segregation, physical appearance, location in production, together with
labeling, markings, sticker, stamps and/or other means. The finished products
that undergone QC checking be identified with status “OK or NG” in the
Inspection Data Sheet

Refer to Inspection and Testing Procedure

7.5.4 Customer Property

COMPANY ABC has received customer intellectual property for use or

incorporation into the product. The customer property herein is referred to
product specification, drawings and other proprietary information.
COMPANY ABC shall identify, verify, protect and safeguard all the customer
property. If any customer property is lost, damaged or otherwise found to be
unsuitable for use, COMPANY ABC shall immediately notify customer in
writing or orally.

7.5.5 Preservation of Product

COMPANY ABC shall preserves the conformity of product from materials

and child parts receiving until delivery to the intended destination. Storage
areas are allocated for the purpose of preservation of materials, parts and
finished products. The storage areas shall be protected from undesirable
environmental and are readily identifiable. Effective methods of receiving and
dispatching of materials and parts upon request either for production or
maintenance shall be established.

COMPANY ABC shall ensure the related personnel complies with the method
and work instructions for handling of incoming materials or parts handling, in-
process and finished products. This is to avoid any unwanted incident and to
ensure the materials, parts as well as the end products are always available in
the good conditions.
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COMPANY ABC shall arrange for the protection of the finished products
during loading process until the delivery to desired destination.

Refer to Handling, Storage and Delivery procedure

7.6 Control of Monitoring and Measuring Equipments

COMPANY ABC shall provide necessary inspection, measuring and test equipments
to assure the products conform to the requirements. These equipments shall be
controlled, calibrated and maintained and their measurement capability and accuracy
shall be consistent with the intended application.

COMPANY ABC shall use external laboratories to calibrate the master inspection,
measuring and test equipments at appropriate interval. Labels shall be attached to all
calibrated inspection, measuring and test equipment to indicate the calibration status.
This shall include the calibration due date and equipment identification number and
other pertinent information as well. A master list of all inspection, measuring and test
equipments shall be established.

When inspection, measuring and test equipments is found to be out of calibration,

COMPANY ABC shall validate the previous inspection and test result, as appropriate
and a decision shall be made as to re-inspect, re-test or otherwise, declare it as
defective. The equipment that declared as defective shall be removed from use or
suitably identified until it is repaired and calibrated.

COMPANY ABC shall store and handle all the inspection, measuring and test
equipments in proper manner to prevent deterioration, damage, or alteration to the
functional or dimensional characteristics.

Any associated computer software used in the inspection, measuring and test
equipment shall be confirmed prior initial used.

A procedure to coordinate the control, tracking, calibration, maintenance and handling

of all the equipment has been established.

Refer to Calibration Procedure.

8.1 General
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COMPANY ABC shall establish a plan for monitoring, measurement, analysis and
improvement activities occurs at two levels as below:-
a) Product level
In this level, COMPANY ABC shall assure and able to demonstrate the product
conformity through an effective and efficient manufacturing processes,
monitoring activities, daily inspection operation and records as well.

Factory Manager is responsible to decide, organize and set up the above

mentioned manufacturing processes, monitoring activities, daily inspection
operation and records and make sure these activities being carried out
efficiently by all the related personnel.

b) System level
In this level, COMPANY ABC shall ensure and able to demonstrate conformity
of the Quality Management System to ISO 9001 standard, Quality Policies and
Quality Objectives as well as Standard Operating Procedures.

The Management Representative and the appointed personnel are responsible to

establish a plan which shall include Internal Quality Audit and Customer
Satisfaction Measurement and other related issues.

8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

COMPANY ABC shall have the capability to meet all the customer
requirements as stipulated during contract review. The customer requirements
shall be well understood, adequately defined and documented.

The Sales and Marketing personnel shall collect and monitor information
relating to customer perception to determine whether customer requirements
are met through the customer satisfaction survey, customers complaints
received and customers’ feedback.. All these data and information obtained
shall be recorded and analyzed, and necessary actions shall be taken to
enhance the level of customers’ satisfaction.

A procedure for handling customer complaints and customer satisfaction

measurement has been established.

Refer to Customer Complaints And Satisfaction Survey Procedure

8.2.2 Internal Quality Audit

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COMPANY ABC shall perform an internal quality audit at regular interval to

determine the compliance and its effective implementation of the established
quality management system to the planned arrangement, standard and
company’s quality system requirement.

COMPANY ABC shall form an internal audit team for performing the internal
quality audit at least once a year. The Management Representative is
responsible for scheduling and managing the audit program.
The audit activities shall be scheduled on the basis of :
 the status and importance of the activity and processes to be audited .
 previous audit results ( internal and external)

The members of the audit team shall be trained and qualified .The members of
the audit team shall also be independent of the area being audited.

All the findings from the audit shall be recorded and reported to the
Management Representative or discuss with the Department Head of the area
audited in order to carry out suitable corrective actions necessary to rectify the
deficiencies identified during the audit. Any corrective action required, shall
be taken timely. Once the action is performed, the audit team or management
representative or appointed representative shall follow - up the deficient area
to verify the effective implementation of corrective actions. The results of the
internal quality audit shall form an integral part of Management Review.

A procedure for planning, maintaining and conducting internal audit and its
reporting has been established.

Refer to Internal Audit Procedure.

8.2.3 Monitoring and Measurement of Processes

COMPANY ABC shall apply suitable methods for monitoring of quality

management system processes in conjunction with the set Quality Objectives.
The monitoring methods used shall be verifiable in demonstrating the ability
of the processes to meet the set objective. Where applicable, criteria
performance measurement for some of the processes in Quality Management
System shall be determined as well. Performance measurement shall be
measured and analyzed. When planned results are not realized, COMPANY
ABC shall take correction and corrective action to verify those product
requirements have been met.
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8.2.4 Monitoring and Measurement of Product

COMPANY ABC shall monitor and measure the product characteristics to

ensure their conformity to specification. COMPANY ABC shall dictated
necessary product inspections and/or test that associated with the acceptance
criteria in the Quality Control Plan. Evidence of conformity with all of the
acceptance criteria throughout the production process shall be maintained
according to Inspection And Testing procedure. QC Supervisor is authorized
to release of product to subsequent operations, finished goods store or
customers. COMPANY ABC shall not release any product to customer until
all planned arrangements have been satisfactorily completed, unless requested
and approved by the customers.
Please refer to Inspection and Testing Procedure

8.3 Control of Non-conforming Product

Any products found to be non-conforming to specified requirements shall be

identified, marked and/or segregation of the product while awaiting disposition in
order to prevent from being further processed or delivery to customers.

Non-conforming product could be detected during receiving of materials and child

parts, manufacturing process, finished goods store, customer feedback and complaints
or due to supplier quality problem. It must be documented and report generated.

All QC personnel are authorized and responsible in identifying and reporting the non-
conformities upon detection and to control further processing until the unsatisfactory
condition has been corrected. Upon detection of non-conformities, QC personnel shall
issue a Non-Conforming Report, pending review and disposition by the Managing
Director.

The rejected item shall be segregated while disposition is being determined to prevent
it from inadvertent use. Then, its details shall be documented and forwarded to QC
Supervisor as appropriate for further action. The disposition of non-conforming
products shall be as the following, as appropriate:-
 Accept As It is
 Rework/Repair
 Hold for Evaluation
 Scrapped
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 Return to vendor
 Other

Managing Director shall authorize decision on disposition. Once the non-conformities

are corrected, where practical, the re-inspection against criteria which originally failed
shall be carried out.

COMPANY ABC shall communicate with the customer for the actual condition of
the product. An approval in writing, where applicable, shall be obtained from the
customers and the details of non-conformities shall be recorded.

If non-conforming product is detected after the release to customers, COMPANY

ABC shall responsible for the conformities and take corrective action that appropriate
to the effects, or potential effects of the non-conformities.

A procedure for the control of non-conforming products to prevention from

unintended use or delivery has been established.

Please refer to Control of Nonconforming Product Procedure

8.4 Analysis of Data

COMPANY ABC shall determine, collect and analyze appropriate data to

demonstrate the suitability and effectiveness of the Quality Management System. The
data shall be ensured to be useful for continual improvement of the effectiveness of
the Quality Management System. This shall include data generated as a result of
monitoring and measurement and from other relevant sources as the following but not
limited to:
a) Customer satisfaction
b) Conformity to product requirements
c) Characteristics and trends of processes and products including opportunities for
preventive action
d) Supplier

Appropriate statistical techniques may be used for analyzing the data or information
collected so as to verify the acceptability of process capability and product
characteristic and subsequently to identify areas for further improvements.

8.5 Improvement

8.5.1 Continual Improvement

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COMPANY ABC shall always plan for the continual improvement on the
effectiveness of the Quality Management System through the use of Quality
Policy, Quality Objectives, audit results, analysis of data, corrective and
preventive actions and the Management Review as well. All the QMS Steering
Committee member have the responsibility to identify and suggest any
necessary improvement to the top management.

8.5.2 Corrective Action

COMPANY ABC shall take necessary action to eliminate the cause of non-
conformities in the event of system or product quality failure, appropriate to
the effects of the non-conformities found. The corrective action shall be taken
in a timely manner and action instituted to prevent re-occurrence of the similar
problem.

COMPANY ABC corrective action defines requirements to:-

a) Identify non-conformity (including customer complaints)
b) Determine and analyzing the causes of non-conformity
c) Evaluate the need for actions to forestall the recurrent of the identified
non-conformity
d) Determine and implementing the corrective action needed
e) Verify the effectiveness of the corrective action taken

A documented procedure for the control of corrective action has been

established.

8.5.3 Preventive Action

COMPANY ABC shall identify preventive action to eliminate potential causes

of non-conformities to prevent occurrence. The source of information can be
collected through the data analysis, audit results, inspection and test,
customers’ feedback, customer survey and other possible sources. Preventive
actions taken shall be appropriate to the impact and magnitude of the potential
problems.

COMPANY ABC preventive action defines requirements to:-

a) Identify potential non-conformities and their causes
b) Evaluate the need for action to prevent occurrence of non-conformities
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c) Determine and ensure the implementation of preventive action needed

and effective
d) Record results of action taken
e) Verify the effectiveness of preventive action taken

A documented procedure for the control of preventive action has been

established.