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The xyz Sdn. Bhd. Document No.

: IM-01
Revision No. : 0
INTEGRATED MANAGEMENT SYSTEM MANUAL
Effective Date : 12/01/05

STANDARD CLAUSES
SECTION CONTENT ISO ISO PAGE
9001:2000 14001:2004
1.0 INTRODUCTION

1.1 Company Background

1.2 Our Products & Customers 5.2


1.1, 1.2,
1.3 Purpose, Scope & Exclusions of IMS 1, 4.4.4
4.2.2(a)

1.4 IMS Manual Administration 4.2.3 4.4.5

2.0 POLICY & OBJECTIVES

2.1 Policy Statement 5.3 4.2

2.2 Objectives Statements 5.4.1 4.3.3

5.1, 5.3,
5.4.1, 4.2.3, 4.2, 4.3.3,
2.3 Policy & Objectives Control 5.5.3, 4.4.5, 4.4.3,
6.2.2(c), 4.5.1
8.5.1

2.4 Continual Improvement Programs 8.5.1 4.3.3

3.0 QUALITY & IMS PLANNING


Business Process & IMS Planning
4.1, 4.2.2(c),
3.1 (A) xyz Technology Business Process 4.4.3, 4.4.4
5.4.2, 7.1(a)
(B) Mapping of Business Process with Standards

3.2 Quality Planning 7.1(a) – (d)

3.3 Environmental Aspects & Impacts 4.3.1

4.2.1(c) – (d),
3.4 List of Procedures 4.2.2(b), 4.4.4
7.1(b)

4.0 ORGANIZATION & IMS

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The xyz Sdn. Bhd. Document No. : IM-01
Revision No. : 0
INTEGRATED MANAGEMENT SYSTEM MANUAL
Effective Date : 12/01/05

4.1 Organization Structure 5.5.1 4.4.1

4.2 Responsibilities & Authorities 5.5.1 4.4.1

4.3 Management Responsibilities & Authorities 5.5.1 4.4.1

4.4 Management Representative 5.5.1, 5.5.2 4.4.1

4.5 Internal Communication 5.5.3, 5.1(a) 4.4.3

4.6 Control of Documents 4.2.3 4.4.5

4.7 Control of Records 4.2.4 4.5.4

5.0 RESOURCES MANAGEMENT 4.4.1


6.1, 6.2.1,
5.1 Human Resources 6.2.2 4.4.2

5.2 Infrastructure Resources 6.1, 6.3, 7.6 4.5.1

5.3 Work Environment 6.1, 6.4 4.5.1

6.0 CUSTOMER MANAGEMENT PROCESSES


5.2, 5.5.2(c),
7.2.1, 7.3.2,
6.1 Customer Needs, Wants & Expectations 7.5.1(f), 1.2,
4.2.2(a)

6.2 Legal & Other Requirements 4.3.2, 4.5.2

6.3 Customer Communication Processes 7.2.3, 7.5.4

6.4 External Communication Process 4.4.3


7.2.3(a) – (b),
6.5 Customer Inquiry Handling Processes 5.2, 8.1

6.6 Customer Property Handling Processes 7.5.4


7.4.1, 7.4.2,
6.7 Customer Appointment of Vendors 7.4.3
7.2.1, 7.2.2,
6.8 Order Processing Processes 7.2.3(b), 1.2,
4.2.2(a)
7.2.3(c),
6.9 Customer Feedback Processes
8.5.2(a),

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The xyz Sdn. Bhd. Document No. : IM-01
Revision No. : 0
INTEGRATED MANAGEMENT SYSTEM MANUAL
Effective Date : 12/01/05

8.2.1, 8.5.1

6.1 Customer Satisfaction Measurement Processes 8.2.1, 8.4(a)

7.0 MATERIALS MANAGEMENT PROCESSES

7.1 Vendor Control Processes 7.4.1, 8.4(d)

7.2 Purchasing Processes 7.4.2 4.4.6(c)

7.4.3, 8.2.4,
7.3 Control of Purchased Product Processes
8.3

8.0 OPERATIONS MANAGEMENT PROCESSES

8.1 Control of Product / Service Realization 7.1, 7.5.1

8.2 Special Processes 7.5.2

8.3 Emergency Preparedness & Response 4.4.7

8.4 Identification & Traceability Processes 7.5.3

Handling, Packing, Storage, Preservation &


8.5 7.5.5
Delivery

8.6 Monitoring & Measurement of Processes 8.2.3

8.7 Monitoring & Measurement of Products 8.2.4

8.8 Control of Non-Conformities 8.3 4.5.3

9.0 REVIEW & IMPROVEMENT

9.1 Monitoring & Measurement of IMS 8.2.2 4.5.5

9.2 Analysis of Data 8.4

9.3 Corrective & Preventive Actions 8.5.2, 8.5.3 4.5.3

9.4 Management Review 5.6 4.6

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The xyz Sdn. Bhd. Document No. : IM-01
Revision No. : 0
INTEGRATED MANAGEMENT SYSTEM MANUAL
Effective Date : 12/01/05

1.0 INTRODUCTION

1.1 COMPANY BACKGROUND

The xyz Sdn. Bhd. had been established since 1948, with an initial paid up capital of RM__________. It
started as a trading house, located at zzz, with an estimated headcount of less than 10 dedicated employees. It
started with first production back in 1950, with annual capacity.........

The top management comprises of 3 strong leadership roles where the Managing Director – Mr. Rrr holds
the reins and spearheading the organization towards its goals. The xyz Sdn. Bhd. uses efficient resources and
is capable of generating RM 8 million sales turnover per annum.

Since incorporation, The xyz Sdn. Bhd. has been growing at a tremendous pace. Currently, xyz is making its
global presence with six other subsidiary entities, strategically located worldwide. They are:

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1.2 OUR PRODUCTS & CUSTOMERS
1.3 PURPOSE, SCOPE & EXCLUSIONS OF INTEGRATED MANAGEMENT SYSTEM

Purposes

The purposes of establishing, documenting, implementing and maintaining an Integrated Management


System (IMS) in accordance to the triple standards of the ISO 9001:2000, ISO 14001:2004 and OHSAS
18001:1999 Standards are to:

§ Demonstrate our ability to consistently provide an effective operations, producing quality products
which fulfills customer requirements, in an environmentally friendly way, that meets the requirements of
customers, applicable regulations and The xyz Sdn. Bhd. At the same time, ensuring an occupationally
healthy and safe working environment.

§ Enhance customer satisfaction through effective application of the IMS, continual improvement of the
IMS and assurance of conformity to requirements.

§ Establish a self regulatory system to monitor compliance to safety, health and environmental legal and
other requirements.

The IMS Manual describes the core elements of the IMS, its processes and their interaction, as well as
provides direction to related documentation.

Scope

The scope of the IMS covers the business of:

Exclusions

Operations and activities pertaining to those products and facilities not included in the scope as specified
above, shall be excluded from the scope of the IMS.

Exclusions to the permissible requirements of ISO 9001:2000 shall be documented at the respective sections
of this IMS Manual, with justification included.
The company IMS is established in line with the requirements of both the company business needs and
international standards of ISO 9001:2000 and ISO 14001:2004. It is documented on formal IMS Manual,
procedures, instructions, standards, and guides.

The IMS as practiced by the company is documented into the three distinct levels:

Level 1

Level 2

Level 3

Level 1: IMS Manual, authorized by the Managing Director, defines the overall company Policy and the
mandatory operational policies to meet both business needs and ISO 9001:2000, ISO 14001:2004
and OHSAS 18001:1999 requirements. The purpose of this IMS Manual is to provide an overview
of the IMS of The xyz Sdn. Bhd. and the policies in practice in the company.

Level 2: Procedures, authorized by the Management Representative and the Managing Director, define the
responsibilities and ways business operates in support of the mandatory operational policies
outlined in the IMS Manual.

Level 3: Supporting documents, authorized by respective Departmental Heads and/or the


Management Representative, define the details operations in support of the procedures. These include work
instructions, standards, test methods, specifications and forms.
1.4 IMS MANUAL ADMINISTRATION

This IMS Manual, as the governing document in setting the direction of the company with regards to quality
environment, health and safety, shall form the basis of the operations to ensure quality of products are
delivered to our customers, as well as compliance with environmental, health and safety performances.

This IMS Manual shall be maintained and updated by the Management Representative, per TMS-02 Control
of Documents Procedure. Uncontrolled copies may be issued to customers and third party organizations,
which have a need to review the company's IMS. The IMS Manual may only be permitted to make copies for
external parties upon approved by Management Representative. This has been detailed in the TMS-02
Control of Documents Procedure.

References:

TMS-02 Control of Documents Procedure


The xyz Sdn. Bhd. Revision No. :
Effective Date:

2.0 POLICY

2.1 POLICY STATEMENT

The xyz Sdn. Bhd. is fully committed to provide its Customers


with Quality and Reliable products and services that shall meet
Total Customer Satisfaction, and at the same time, preventing
environmental pollution.

In achieving this, we shall:

§ Be committed to meeting requirements of customers, as well as those of legal,


regulatory and statutory requirements pertaining to product and environment.

§ Continually improve the effectiveness of our Integrated Management System and


its processes.

§ Adopt the Reduce-Reuse-Recycle concept, wherever applicable.

This Policy can be made available to the public upon receipt of formal request.
2.2 OBJECTIVES STATEMENT

Since the Policy demonstrates The xyz Sdn. Bhd. on its overall intention and direction of where it desires to
steer forward, it shall provide a framework for establishing, reviewing and deploying the below Objectives, to
the organization, to ensure consistency with the Policy:

§ Achieve 85% overall Customer Satisfaction

§ Achieve no more than 10 Justified Customer Complaints per year

§ Achieve RM 10 million Sales Turnover for Year 2005

§ Achieve 100% On-Time Delivery

§ Achieve Zero Rejects from Suppliers

§ Achieve 85% overall Supplier Evaluation

§ Achieve 100% Compliance with all Legal & Regulatory Requirements

§ Achieve / Maintain Certification to ISO 9001 and ISO 14001

§ No Public / Regulatory Complaint on Environmental Pollution

Reduce cost by 5% per annum


2.3 POLICY & OBJECTIVES CONTROL

The Policy & Objectives, as expressed by the Managing Director, serves as the direction and commitment of
the company with regards to quality, environment health and safety, as such the Policy & Objectives shall
remain in force until a decision is made to amend them. The IMS Manual will be updated whenever there is
any formal change to the Policy and/or Objectives, via the TMS-02 Control of Documents Procedure.

The Policy & Objectives shall be disseminated to all the employees of the company by means of posters at
strategic locations, orientation program (as per HM-03 Orientation Procedure), regular briefings and
occasional campaigns. Every employee shall not only recognize the Policy & Objectives, but to understand
their contents and intentions, as a step towards aligning the company towards the same commitment.

The implementation and maintenance of the Policy & Objectives shall be the responsibility of all employees
of the company by ways of practicing the Integrated Management System that this IMS Manual outlines
together with the associated procedures and supporting documents.

The Policy provides a framework for setting and reviewing Objectives. These Objectives are company-wide
goals, which encompass the qualitative and quantitative aspects. The Objectives shall address the results of
the environmental impact and OH&S risk assessments, as well as the effects of the controls associated to
them. The Objectives are cascaded to relevant functions and levels of the organization. The deployment
process has been addressed in the TMS-01 Deployment of Policy, Objectives, Targets & Improvement
Programs Procedure. The Performance Indicators shall be consistent with the Objectives, which in turns
supports the Policy. These measurable Objectives shall be used as means to ensure the Policy is being
complied with as well as a mean to propel the company towards continual improvement.

The Objectives shall be communicated to relevant functions and levels of the organization by means of
displaying performance charts at pre-defined locations. This has been addressed in the TMS-01 Deployment of
Policy, Objectives, Targets & Improvement Programs Procedure. In addition, the Objectives and Performance
Indicators will also be reviewed on their achievements per TMS-08 Management Review Procedure, at
periodic intervals, to seek for further improvements. The Objectives should not change unless they have been
successfully attained.

References:

TMS-01 Deployment of Policy, Objectives, Targets & Improvement Programs Procedure

TMS-02 Control of Documents Procedure

TMS-08 Management Review Procedure


HM-03 Orientation Procedure
2.4 CONTINUAL IMPROVEMENT PROGRAMS

Continual Improvement Programs may be initiated for Objectives when the need arises, to ensure a
systematic approach to manage all the activities is used. TMS-01 Deployment of Policy, Objectives, Targets
& Improvement Programs Procedure has been established which specified the need to include:

· Designation / name of responsibility for implementing the respective activities for the Continual
Improvement Programs;

· Time frame by which each of the activity listed in the Continual Improvement Program, to be completed.

The progress of the identified Continual Improvement Programs shall be reviewed periodically via the TMS-
08 Management Review Procedure. If there is any change to any of the activity listed in the respective
Continual Improvement Programs, with regards to new developments, new or modified activities, products
or services, these programs shall be amended.

References:

TMS-01 Deployment of Policy, Objectives, Targets & Improvement Programs Procedure

TMS-08 Management Review Procedure


3.0 QUALITY & IMS PLANNING

3.1 BUSINESS PROCESS & IMS PLANNING

The xyz Sdn. Bhd. shall ensure that the IMS established, documented, implemented and maintained, in order
to meet the Policy & Objectives set forth. The establishment of IMS in The xyz Sdn. Bhd. is based on the
business needs and actual operations of the organization. Below diagram is a conceptual representation of our
approach to establishment of an IMS in The xyz Sdn. Bhd.

Dept Dept Dept Dept


A B C D

Procedure X1 for sub-process X1


Procedure X2 for sub-process X2

Business
Process

ISO 9001, ISO 14001 & OHSAS 18001 Requirements


The Core Process Blocks of The xyz Sdn. Bhd. is represented diagrammatically as follows:

Integrated Management System

Customer Management Process

Materials Operation Facility


Management Management Management
Process Process
Process

Human Resources Management Process

Based on the above Core Process Blocks, The xyz Sdn. Bhd. has developed a Business Process Flow, as
shown in Section 3.1(A), which:

§ Identified the processes needed for the IMS and their application throughout the organization.

§ Determined the sequence and interaction of the processes, both operational and supporting.

§ Briefly describe the interaction between these processes of the IMS. The detailed description of
interaction of the processes can be shown in the individual procedures where cross-references between
one another are made.

This Business Process Flow demonstrates its ability to meet the following criteria:

§ ISO 9001:2000, ISO 14001:2004 and OHSAS 18001:1999, as shown in Section 3.1(B), where the
Standard requirements had been mapped with the Business Process Flow.

§ Own requirements, where second level procedures had been mapped with the Business Process Flow.
These procedures set forth the criteria and methods to ensure that both the operation and control of these
processes are effective. They also define the necessary resources (such as responsibilities of personnel)
and information (for example, in the form of data to be recorded) needed to implement the documented
IMS accordingly.

The Business Process Flow identified the necessary processes of The xyz Sdn. Bhd. in the IMS, and these
processes have been documented in terms of second level procedures, which means that the procedures reflect
the process approach. They were not documented based on functional activities. Instead, these procedures
outline all activities pertaining to the respective processes, which cuts across various departments.

The xyz Sdn. Bhd. adopts a Plan-Do-Check-Act (PDCA) approach when establishing and documenting the
IMS. This can be shown in 3 ways:

§ By proper application of ISO 9001:2000 and ISO 14001:2004 requirements, since the requirements
themselves can be structured in the form of PDCA cycle. This means that the processes needed for the
IMS had adequately addressed those processes for management activities, provision of resources, product
realization and measurement.

§ Wherever appropriate, planning-related procedures (such as those regarding human resources planning
and equipment planning), doing-related procedures (such as those addressing production processes),
checking-related procedures (such as those required for verification, validation, monitoring, inspection
and test activities) and action-related procedures (such as those regarding corrective and preventive
actions) will be documented.

§ Wherever appropriate, the individual procedures will be documented based on PDCA. Planning would
include defining requirements for processes in the procedure, including regulatory, internal and external
customer requirements. Doing would define the mechanisms and resources for implementing the
procedures. Checking would include data collection and compilation, as a means of monitoring and
measuring IMS processes, as well as data analysis to identify and communicate strengths, weaknesses and
trends. Action would include the need for improvements, based on the data compiled and analyzed, for
further improvement of these processes.

Internal Communication

The data collected and compiled as per defined in the respective procedures shall be communicated to all
relevant functions and levels of the organization, as they pertain to the effectiveness and efficiency of the
IMS. Methods of communication include:

§ Distributing records / compiled results to concerned parties.

§ Displaying appropriate compiled results at designated prominent locations.


§ Briefing during scheduled meetings.

HR-07 Communication Procedure had been established which detailed:

· Internal communication methods, between the various levels and functions of The xyz Sdn. Bhd.;

· External communication, with regards to receiving, documenting and responding to relevant external
parties. This had been reinforced with the CM-04 Handling of External Complaints Procedure.

Outsourced Processes

The xyz Sdn. Bhd. by nature of its incorporation is a trading house, meaning that it does not manufacture any
of the products supplied to the customers. Instead The xyz Sdn. Bhd. Source from various suppliers to identify
the products which meet the customers' requirements. And to control the sourcing activities, procedures have
been established, to comply with ISO 9001:2000 Clause 7.4 requirements.

For the purpose of certification and compliance with requirements of the ISO 9001:2000 Clause 4.1, The xyz
Sdn. Bhd. currently does not outsource any of its processes, as identified in Business Process Flow.

If there is any outsourcing in future, the extent of control of the outsourced processes shall be separately
identified in the respective documented procedures.

Maintenance of IMS

The xyz Sdn. Bhd. shall establish and maintain its IMS in the paper medium, comprising of the first, second
and third level documentation.

Minor changes to the IMS requirements are controlled as per TMS-02 Control of Documents Procedure, where
the Management Representative is responsible to review all changes to first and second level documentation,
prior to use. This is to ensure the integrity of the IMS is maintained whenever changes have been initiated by
other personnel of the organization.

Where major restructuring or re-engineering of the IMS is required, such as when upgrading the IMS to meet
ISO 9001:2000 requirements, parallel implementation of previous and new systems shall be carried out
concurrently during the transition period. Staggered removal of previous system will be performed, over a
reasonably comfortable time frame. This is to ensure familiarization of new IMS by employees, as well as to
assure that the integrity of the IMS is maintained. In the event of major restructuring of IMS, this will be
carried out systematically, via the TMS-01 Deployment of Policy, Objectives, Targets & Improvement
Programs Procedure.
References

All Procedures

TMS-02 Control of Documents Procedure

TMS-01 Deployment of Policy, Objectives, Targets & Improvement Programs Procedure

TMM-01 Vendor Selection & Evaluation Procedure

TOM-05 Control of Non-Conformities Procedure

THM-07 Communication Procedure

TCM-04 Handling of External Complaints Procedure


3.1(A) THE xyz BUSINESS PROCESS FLOW

Management
Integrated Management System Responsibilities

Vendor Selection Legal Customer Resources Business


& Evaluation Requirements Requirements Management Development

Materials Planning New Brand


Introduction

Sourcing / Internal Purchasing Order Processing


Continual
Improvement
Receiving / Monitor Delivery
Verification

Material Storage

Material Issuance

Continual
Improvement

Delivery

Customer / External Feedback


3.1(B) MAPPING BUSINESS PROCESS WITH ISO 9001:2000 & ISO 14001:2004

3.2 QUALITY PLANNING

The xyz Sdn. Bhd. shall identify and plan the activities and resources needed to achieve Objectives. This
planning shall be consistent with other requirements of the Integrated Management System and the results
shall be documented in all the second level procedures.

Quality planning shall be carried out, reviewed if current processes and resources required in the Integrated
Management System are suitable, identifying quality characteristics at different stages as to achieve the
desired results. The planning shall also cover the verification activities, criteria for acceptability and the
records needed. Quality planning shall be carried out to ensure customer contracts can be fully satisfied. The
planning shall ensure that any organizational change in The xyz Sdn. Bhd. as a result of planning be
conducted in a controlled manner and that the IMS is maintained during this change.

References:

All procedures

3.3 ENVIRONMENTAL ASPECTS & IMPACTS

The xyz Sdn. Bhd. had established and documented a TTOM-03 Identification & Evaluation of
Environmental Aspects Procedure, to provide the mechanism for:

· Identifying the environmental aspects of its activities, products and services that it can control and
over which it can be expected to have an influence;

· Determining those environmental aspects which have or can have significant impacts on the
environment;

· Determining control measures for those environmental aspects which have or can have
significant impacts on the environment; and

· Ensuring the information captured in the documents are kept up-to-date, via the TMS-02 Control
of Documents Procedure.

References:
TTOM-03 Identification & Evaluation of Environmental Aspects Procedure
TMS-02 Control of Documents Procedure

3.4 OH&S HAZARDS & RISKS

The xyz Sdn. Bhd. had established and documented a OM-02 Identification & Evaluation of OH&S
Hazards Procedure, to provide the mechanism or methodology for:

· Proactively and reactively identifying the OH&S hazards of its activities, products and services
that it can control and over which it can be expected to have an influence, whether they are
routine or non-routine, and that employees and/or persons working on behalf have access to these
activities, products and services;

· Determining those OH&S hazards which have or can have significant risk to the employees
and/or persons working on behalf of xyz;

· Classifying risks such that those significant ones be identified for risk elimination;

· Determining control measures which are consistent for those OH&S hazards which have or can
have significant risk to the employees and/or persons working on behalf of xyz; and

· Ensuring the information captured in the documents are kept up-to-date, via the TMS-02 Control
of Documents Procedure.

The results of the risk assessment and effects of the controls are considered when setting the Objectives,
which had been detailed in the MS-01Deployment of Policy, Objectives, Targets & Programs Procedure.

References:

OM-02 Identification & Evaluation of OH&S Hazards Procedure

TMS-02 Control of Documents Procedure

MS-01Deployment of Policy, Objectives, Targets & Programs Procedure


3.5 LIST OF PROCEDURES

TMS-01 Deployment of Policy, Objectives, Targets & Improvement Programs Procedure

TMS-02 Control of Documents Procedure

TMS-03 Control of External Document Procedure

TMS-04 Identifying & Maintaining Legal & Other Requirements

TMS-05 Control of Records Procedure

TMS-06 Internal Audit Procedure

TMS-07 Environmental Monitoring & Measurement

TMS-08 Management Review Procedure

TMS-09 Corrective & Preventive Actions Procedure

THM-01 Human Resources & Competency Planning Procedure

THM-02 Recruitment & Selection Procedure

THM-03 Orientation & Induction Training Procedure

THM-04 On-Job Training Procedure

THM-05 Internal / External Training Procedure

THM-06 Training Needs Analysis Procedure

THM-07 Communication Procedure

THM-08 Emergency Preparedness & Response

TCM-01 Marketing Planning & Forecasting Procedure

TCM-02 Handling of Customer Inquiry Procedure

TCM-03 Order Processing Procedure

TCM-04 Handling of External Complaints Procedure

TCM-05 Customer Survey & Feedback Procedure

TMM-01 Vendor Selection & Evaluation Procedure

TMM-02 Sourcing Procedure

TMM-03 Delivery Procedure

TMM-04 Internal Purchasing Purchasing


TMM-05 Incoming Receipt, Verification & Preservation of Internal Purchased Products

TOM-01 House Brand Label Design & Development Procedure

TTOM-03 Identification & Evaluation of Environmental Aspects Procedure

TOM-03 Environmental Operation Control Procedure

TOM-04 Waste Management Procedure

TOM-05 Control of Non-Conformities Procedure

TFM-01 Facilities Planning & Control Procedure

TFM-02 Preventive Maintenance Procedure

TFM-03 Breakdown Maintenance Procedure


4.0 ORGANIZATION AND INTEGRATED MANAGEMENT SYSTEM

4.1 ORGANIZATION STRUCTURE

Managing Director

LOGISTICS /
SALES & HUMAN RESOURCES / FINANCE /
SOURCING /
MARKETING ADMINISTRATION
PROCUREMENT

Sales & Marketing


Finance Director Finance Director
Director

Sales & Marketing


Manager(s)

Sourcing & Finance &


Human Resources
Procurement Administration

Customer Service Accounts & Admin


Finance Director
Executive Officer

Logistics
Managing Director

Logistics & Sales


Coordinator

Clerk Clerk

4.2 RESPONSIBILITIES & AUTHORITIES

The responsibility for the IMS shall be a shared responsibility by all employees in the company. The
authorities and responsibilities of each employee shall be as defined in the Job Description and related
procedures.

The Organization Structure, as shown in Section 4.1, which supports the IMS, provides an overview of the
hierarchical responsibility, authority and inter-relationship of each department. Job specific responsibilities
and authorities are defined and documented in:

§ Appointment Letters, provided to individual employees;

§ Job Descriptions, which include the need to establish for those personnel involved in cross-functional
activities such as Internal Audit;

§ Respective procedures, and/or support documentation.

Roles, responsibilities and authorities of personnel are communicated during orientation, as per THM-03
Orientation & Induction Training Procedure. Additional or changes to responsibilities and authorities, as a
result of transfer and/or promotion, shall be communicated during appraisals.

Each department shall be empowered in their respective scope of responsibility and authority to:

§ Initiate and document actions to prevent occurrence of any non-conformities;


§ Identify and record problems;
§ Initiate, recommend or provide solutions and improvements to products, processes and/or IMS;
§ Evaluate and verify the solutions implementation processes; and
§ Control further processing or delivery of non-conforming products, until the deficiency has been
rectified.

References:

Job Descriptions (THM-01-W01 to THM-01-W10)

All Procedures

THM-03 Orientation & Induction Training Procedure


4.3 MANAGEMENT RESPONSIBILITIES & AUTHORITIES

4.3.1 Managing Director

§ Profitability and sustenance of the organization.

§ Sets direction, goals and performance targets for departments.

§ Identify current and future customer needs, wants and expectations, and strategize to increase
market recognition and share.

§ Provide resources to ensure effective and efficient management of operations and control.
Resources include human resources and specialized skills, technology and financial resources.

§ Comply with company law and regulations.

§ Liaison with customers on quality issues.

§ Provide customer services and maintain customer satisfaction.

§ Promote quality awareness and customer requirements throughout the organization.

§ Communicate Policy, Objectives and Performance Indicators as well as responsibilities and


authorities, to all relevant staff.

4.3.2 Finance Director

§ Purchase materials to meet quality, quantity, price and delivery requirements.

§ Communicate customer and/or legal requirements to staff in the department, and vendors if
necessary.

§ Effective planning for materials, production and delivery, to meet on-time shipment to
customers.

§ Liaison with transporter and customs.

§ Import of materials and export of finished goods.

§ Communicate customer requirements to staff in the department, and vendors if necessary.

§ Identify need for new equipment and factory machinery.

§ Implement effective preventive maintenance programs, for all office equipment and machinery.

§ Ensure minimal downtime of office equipment for efficient operation.

§ Identify manpower needs to support the business and operations.

§ Recruitment of employees, including overseas workers.


§ Identify competency requirements for all functions and levels of the organization.

§ Provide training to improve the employee job performance.

§ Authority to terminate employees, if performance found unsatisfactory.

§ Maintain all books of accounts to meet Accounting Standards and regulatory requirements.

§ Adequate reporting on financial status of the organization.

§ Perform regular stock take.

§ Communicate Policy, Objectives and Performance Indicators as well as responsibilities and


authorities, to all relevant staff.

§ Implement and maintain IMS, in accordance to ISO 9001:2000 and ISO 14001:2004
requirements.

4.3.3 Sales & Marketing Director

§ Ensure effective inquiry and order handling processing

§ Provide customer services and maintain customer satisfaction.

§ Translate customer requirements to all relevant functions and levels of the organization.

§ Communicate Policy, Objectives and Performance Indicators as well as responsibilities and


authorities, to all relevant staff.

§ Implement and maintain IMS, in accordance to ISO 9001:2000 and ISO 14001:2004
requirements.
4.4 MANAGEMENT REPRESENTATIVE

The xyz Sdn. Bhd., has appointed the Managing Director as the Management Representative / Appointee of
the company, while the Senior Manager as the Assistant Management Representative / Appointee. The
responsibilities and authorities of the Management Representative / Appointee and the assistant, shall be as
follows:

§ To ensure that processes needed for the IMS are established and documented, to meet requirements of
the organization, as well as ISO 9001:2000, ISO 14001:2004 and OHSAS 18001:1999 Standards;
§ To ensure implementation and maintenance of the established system by managing an Internal Audit
program;
§ To ensure the continuous suitability and effectiveness of the Integrated Management System by
constantly reviewing against the most current ISO 9001, ISO 14001 and OHSAS 18001 Standards and
any other legal and industrial requirements related to the products and services provided; and
§ To ensure the IMS performance is reported and reviewed during the management review as a step
towards continual improvement.

§ To promote awareness of customer requirements throughout the organization.

§ To promote awareness of prevention of environmental pollution.

§ To promote awareness of occupational health and safety at workplace.

The Management Representative / Appointee shall also be in liaison with external parties, customers and
third party certification body on matters relating to the company's IMS.

References:

Job Descriptions (THM-01-W04)


4.5 INTERNAL COMMUNICATION

Communication processes are established within The xyz Sdn. Bhd. to ensure communication takes place
regarding the effectiveness of the IMS. Such processes include:

§ Via Document Control Process, where communication takes place between initiators of new / revised
documents, and the authorized personnel responsible to review and approve those documents. This has
been addressed in TMS-02 Control of Documents Procedure.

§ Via Internal Audit Process, where communication takes place between auditors and auditees, including
top management during the audit as well as closing meeting. The effectiveness of the IMS will be
communicated when auditors present audit findings and make conclusion on the overall IMS. This has
been addressed in the TMS-06 Internal Audit Procedure.

§ Via Management Review Process, where communication takes place amongst management team during
the presentation of reports and achievements, which are directly or indirectly related to the overall IMS.
This has been addressed in the TMS-08 Management Review Procedure.

§ Via Display of Information, at prominent locations, on issues related to customers, audit summaries,
achievements of Objectives, etc., to communicate the effectiveness of the IMS. The information to be
displayed and updated has been captured in the TMS-01 Deployment of Policy, Objectives, Targets &
Improvement Programs Procedure.

§ Via Meetings, where communication takes place on the effectiveness of the IMS, wherever appropriate.
The types and frequency of meetings have been captured in the List of Meetings.

To reinforce, a THM-07 Communication Procedure had been established which detailed:

· Internal communication methods, between the various levels and functions of The xyz Sdn. Bhd.;

· External communication, with regards to receiving, documenting and responding to relevant external
parties. This had been reinforced with the TCM-04 Handling of External Complaints Procedure.

References:

TMS-01 Depoloyment of Policy, Objectives, Targets & Improvement Programs Procedure

TMS-02 Control of Document Procedure

TMS-03 Control of External Document Procedure


TMS-06 Internal Audit Procedure

TMS-08 Management Review Procedure

THM-07 Communication Procedure

TCM-04 Handling of External Complaints Procedure

4.6 EXTERNAL COMMUNICATION

The xyz Sdn. Bhd. had decided to communicate externally about its significant environmental aspects and
OH&S hazards to interested parties.

External communication processes are established within The xyz Sdn. Bhd. to ensure receiving, documenting
and responding to relevant external interested parties such as Department of Environment, Department of
Safety & Health, public, customers, vendors, contractors, neighbors, etc. Such processes include:

§ Via Vendor Control Process, where communication takes place between xyz and persons working for / on
behalf of xyz (e.g. vendors / contractors / suppliers). This has been addressed in MM-01 Vendor Selection
& Evaluation Procedure.

§ Via Handling of External Complaint Process, where communication takes place between xyz and
interested parties where complaints are received pertaining to unacceptable quality, environmental,
occupational health and safety performances. This has been addressed in CM-05 Handling of External
Complaints Procedure.

Via Briefings Process, where communication takes place between xyz and persons working for / on behalf of
xyz (e.g. vendors / contractors / suppliers), where regular / adhoc briefings on requirements to those interested
parties.
4.7 CONTROL OF DOCUMENTS AND DATA

Documented procedures shall be established and maintained to ensure documents and data within the IMS
are controlled, maintained up-to-date for effective operations and control.

Documents and data within the IMS, including all the information necessary for control of processes and to
ensure conformity of product and services shall be determined and identified in master lists indicating
current revision in use. Documented procedures for managing information shall ensure access to and
protection of information. Authorized personnel shall review externally received documents and data for
relevance. Relevant information shall be abstracted and documented into internally generated documents and
data. On periodic intervals, such external originated documents shall be reviewed to identify any new
revisions.

Unique number shall be assigned to facilitate traceability and distribution. Prior to release for use, documents
and data shall be reviewed for adequacy against business needs and ISO 9001:2000, ISO 14001:2004 as well
as OHSAS 18001:1999 requirements and approved by authorized management staff. Documents and data
shall be legible, readily identifiable and retrievable.

Distribution of the documents and data shall be controlled to have relevant copies of documents and data
available at areas with operations controlled by such documents and data. Obsolete or outdated copies of the
documents and data shall be removed and destroyed or indicated to prevent unintended use. All obsolete
copies of documents and data, which are retained for any purpose shall be properly identified, stored and
maintained by the Management Representative and/or Document Controller.

Changes to documents and data shall be controlled. Changes shall be proposed clearly in change requests and
relevant information to facilitate review and approval. The revised documents and data shall indicate the
changes and be reviewed prior to approval by the authorized management.

References:

TMS-02 Control of Documents Procedure

TMS-03 Control of External Document Procedure


4.7 CONTROL OF RECORDS

Records (other than those related to financial and payroll), appropriate to The xyz Sdn. Bhd. shall be
identified, filed, stored and maintained to demonstrate conformance to the product requirements and the
effective operation of the IMS.

Documented procedures shall be established and maintained for the unique and proper identification of
records to facilitate access, retrieval and traceability.

Records within the IMS shall be protected from damage or loss at any time. The company shall ensure all
records being stored properly to prevent any damage, deterioration and/or loss.

Authorized personnel shall review the retention time of various records that are under their control. For long
retention of records, they will be kept in boxes, identified with clear labels and store at designated locations.
The Management Representative / Appointee and/or Document Controller shall be responsible for the
maintenance of keys, to access to these long retention records.

Records within the IMS shall be identified in respective procedures.

References:

TMS-05 Control of Records Procedure


5.0 RESOURCES MANAGEMENT

The xyz Sdn. Bhd. is committed to provide resources needed to establish and maintain the Integrated
Management System. The resources include manpower and specialized skills, relevant information,
technology, infrastructure, appropriate work environment and financial resources. These resources will
enable the implementation of IMS, which ensures customer and/or legal, regulatory requirements are
fulfilled, so as to enhance customer satisfaction.

5.1 HUMAN RESOURCE

The xyz Sdn. Bhd. provides assigned personnel to ensure that those who have responsibilities defined in the
IMS are competent on the basis of applicable education, training, skills and experience. Records of
education, skills and experience are captured in the Job Applications and are maintained in the Personnel
Files.

Competency guidelines are established for all functions and levels of the organization, to define the:

§ Minimum education, academic and professional qualifications

§ Essential skills

§ Relevant experience

§ Necessary Training

All personnel, including those working for or on behalf of xyz, who manage, perform work and verifications
are adequately trained and/or communicated on the procedures and work instructions that support the IMS.

Documented procedures shall be established and maintained for human resources management, including
those, which identify manpower needs, as well as those governing training. Training needs, relative to the
assigned job is identified for each employee to ensure that the employee is capable of performing the
assigned job, especially when competency guidelines are not fulfilled adequately. Training focuses on the:

§ Induction training, to familiarize the employee on the organization, as well as to ensure employee aware
of:

➢ the relevance and importance of their activities and how they can contribute to the achievement of the
Objectives;

➢ their roles and responsibilities during emergency preparedness and response situations

§ On-job training by the immediate superior or experience employee(s), to ensure personnel are aware of:

➢ the importance of conformance with the Policy and procedures and with relevant requirements of the
IMS;

➢ the significant environmental impacts, actual or potential, of their work activities and the
environmental benefits of improved personal performance;

➢ the significant OH&S hazards, actual or potential, of their work activities and the OH&S benefits of
improved workplace performance;

➢ the potential consequences of departure from specified operating procedures.

§ In-house and external training to enhance job knowledge and personal development.

Training evaluations are performed to continually improve the effectiveness of the training conducted as well
as gauge trainees’ understanding and application of training received. Records of training are kept updated by
the respective departments.

References:

THM-01 Human Resources & Competency Planning Procedure


THM-02 Recruitment & Selection Procedure
THM-03 Orientation & Induction Training Procedure
THM-04 On-Job Training Procedure
THM-05 Internal / External Training Procedure
THM-06 Training Needs Analysis Procedure
5.2 INFRASTRUCTURE RESOURCES

The company has defined, provided and maintained the equipment and machinery needed to achieve the
conformity of process and products / service produced. Proper and planned maintenance shall be carried out
to ensure the continuing capability of the equipment, machinery and facilities in meeting the process
requirements, including the need to maintain customer-supplied equipment (if any).

In The xyz Sdn. Bhd., appropriate measuring and monitoring equipment used for product inspection and
testing for acceptability are identified in the master lists. Documented procedures to control and maintain
equipment shall be established for inspection, measuring, test equipment and test hardware / fixture.
Calibration or verification shall be carried out for those measuring and monitoring devices to demonstrate
conformance of the products to specific requirements.

Measuring and monitoring devices shall be used in a manner that ensure that measurement uncertainty,
include accuracy and precision, is known and is consistent with the required measurement capability.

Calibration shall be done by external calibration agencies using standards traceable to National, International
Standards or natural physical properties of materials. Internal verifications shall be carried out to ensure the
continuing capability and functions of the equipment

The company shall ensure environment conditions are suitable for measurements, inspections and tests.

Calibration and verification shall be performed at prescribed interval based on the usage and performance of
each unique equipment as identified on the schedule. Results of the calibration and verification shall be
recorded and maintained. Calibrated equipment shall be identified with calibration stickers to provide
visibility to users on equipment validity. Control on safeguarding the calibrated equipment from further
unauthorized adjustment has been in place.

The company also has documented procedure that ensures the validity of previous inspection and test results
when a device is found to be out of calibration and take appropriate actions.

References:

FM-01 Facilities Planning & Control Procedure

FM-02 Preventive Maintenance Procedure

FM-03 Breakdown Maintenance Procedure

FM-04 Calibration Procedure


5.3 WORK ENVIRONMENT

Work environment as referred to in this IMS Manual is that part of the environment, which is requirement to
achieve conformity to product / service requirements. It also include the need to prevent pollution to the
external environment, and conservation of natural resources, as well as to maintain a healthy and safe
workplace.

The xyz Sdn. Bhd. had established and documented requirements for the environment to which its products /
services, its activities including any product is exposed to. The environmental and workplace conditions need
to be controlled and/or monitored. The TMS-07 Safety, Health & Environmental Monitoring & Measurement
Procedure has been established to address the requirements for controlling and monitoring environmental as
well as occupational health and safety performances, to ensure:

· key characteristics of its operations and activities that can have a significant impact / risks on the
environment and employees respectively are monitored and measured on a regular basis;

· recording of information to track performance, relevant operational controls and conformance with
organization's Objectives and Performance Indicators;

· periodic evaluation on the compliance with relevant environmental, health and safety legislation and
regulations, along with TMS-04 Identifying & Maintaining Legal &Other Requirements Procedure.

Environmental aspects and OH&S hazards have been identified throughout all stages of manufacture, from
receiving of incoming purchased goods, to packing and delivery process, via the TTOM-03 Identification &
Evaluation of Environmental Aspects Procedure and OM-02 Identification & Evaluation of OH&S Hazards
Procedure.

References:

THM-07 Communication Procedure

TMS-07 Environmental Monitoring & Measurement Procedure


TTOM-03 Identification & Evaluation of Environmental Aspects Procedure
OM-02 Identification & Evaluation of OH&S Hazards Procedure
TMS-04 Identifying & Maintaining Legal &Other Requirements Procedure
6.0 CUSTOMER MANAGEMENT PROCESSES

6.1 CUSTOMER NEEDS, WANTS & EXPECTATIONS

The xyz Sdn. Bhd. is fully committed to focus on customers’ needs, wants and expectations, and has
established and maintained documented procedures for ensuring customer requirements are determined, both
current and future.

Current Requirements

The current needs of existing customers are identified and determined, when official orders are received. All
orders committed shall be adhered to, with the aim of enhancing customer satisfaction. These orders will be
processed to ensure all requirements specified or implied, which are necessary for intended use, by the
customers, in terms of product specifications and descriptions, as well as requirements for delivery or
compliance with regulations. This has been addressed in the TCM-03 Order Processing Procedure.

Anticipated Requirements

Existing customer requirements are planned ahead, by forecasting anticipated quantities of different
products of various sizes per customer. This has been addressed in the TCM-01 Marketing Planning
& Forecasting Procedure. The forecast results are then used for planning of product realization as per
OM-03 Production Planning Procedure.

New Requirements

New requirements of existing or potential customers shall be captured, via the TCM-02 Handling of Customer
Inquiry Procedure. When customers do not make official inquiries, new requirements can also be determined
via feedback channels, as defined in TCM-04 Handling of External Complaints Procedure and TCM-05
Customer Survey & Feedback Procedure.

Post Delivery Requirements

The obligations of The xyz Sdn. Bhd. towards its customers end when all terms are satisfactorily fulfilled.
Depending on the terms, if:

§ Ex-Factory terms, all obligations end, once the gloves are delivered out of the factory premises. It is the
onus of the customers to ensure products meet requirements prior to delivery.

§ Free On Board (FOB) terms, all obligations end, once the goods are loaded in containers and on board the
vessel.

§ Cost, Insurance & Freight (CIF) terms, all obligations end when the vessel arrives at the port of
destination. As such, post delivery requirements would include until the goods arrive at the destination.

§ Cost & Freight (C&F) terms, all obligations end when the vessel arrives at the port of destination, only
that the customers bear the charges of insurance expense instead of The xyz Sdn. Bhd.

Other than the above-mentioned requirements, there is no post delivery requirement applicable to The xyz
Sdn. Bhd., under the normal circumstances. As such the ISO 9001:2000 Clause 7.5.1(f) is partially excluded
from the IMS. However, European regulatory requirements (EU) delivered products to be recalled should they
found by users subsequently, to be unsafe. This had been addressed in OM-11 Control of Non-Conforming
Products Procedure.

References:

TCM-03 Order Processing Procedure

TCM-01 Marketing Planning & Forecasting Procedure

OM-11 Control of Non-Conforming Products Procedure

TCM-02 Handling of Customer Inquiry Procedure

TCM-04 Handling of External Complaints Procedure

TCM-05 Customer Survey & Feedback Procedure


6.2 LEGAL & OTHER REQUIREMENTS

The xyz Sdn. Bhd. had established a TMS-04 Identifying & Maintaining Legal & Other Requirements
Procedure to detail the mechanisms for identifying and having access to legal and other requirements to which
it subscribes, that are applicable to the environmental aspects of its activities, occupational health and safety
of workplace as well as products and services it supplied. Any change to these requirements in the master list,
will be made via the TMS-02 Control of Documents Procedure.

References:

TMS-04 Identifying & Maintaining Legal & Other Requirements Procedure

TMS-02 Control of Documents Procedure

6.3 CUSTOMER COMMUNICATION PROCESSES

The xyz Sdn. Bhd. had determined the following arrangements for communicating effectively and efficiently,
with customers pertaining to different issues of concerns. These communication processes had been captured
in the respective procedures, as cross-referenced.

Product Information

§ Managing Director, Sales & Marketing Director, Sales & Marketing Manager(s) and assigned personnel
are responsible to receive customer inquiries with regards to available product information, such as types,
range, packaging, use and applications. They are also responsible to approach new potential customers to
communicate what The xyz Sdn. Bhd. can offer.

Order Handling & Amendments

§ Sales & Marketing Director, Sales & Marketing Manager(s) and assigned personnel are responsible to
receive customers’ orders, and to communicate on all terms of contracts, including subsequent
amendments, such as quantity change, size change, specification change and/or delivery date change.

§ If need arises, the Managing Director is responsible to communicate with customers on prices, and other
order requirements.

§ Unless specified by customers, the Sales & Marketing Director, Sales & Marketing Manager(s) are
responsible to deal with those customers pertaining to delivery requirements, including changes to
delivery dates, terms, etc.

Customer Feedback & Complaints

§ Managing Director, Sales & Marketing Director, Sales & Marketing Manager(s) to receive all customers’
complaints, and communicate with the complaining customers on subsequent actions and arrangements.
They are also responsible to conduct periodic survey or interviews, as a proactive means of monitoring
customer satisfaction.

§ Managing Director, Sales & Marketing Director, Sales & Marketing Manager(s) are responsible to
communicate with customers on quality related issues.

§ If need arises, the Managing Director is responsible to communicate with customers on any customer
complaint issue.

Customer Visits

§ Managing Director, Sales & Marketing Director, Sales & Marketing Manager(s), Finance Director is/are
responsible to accompany customers during visit to factory premises.

The mode of communication between assigned personnel of The xyz Sdn. Bhd. and its customers, include:

§ Telephone

§ Facsimile Transmission

§ Emails

§ Visits

References:

TCM-01 Marketing Planning & Forecasting Procedure

TCM-02 Handling of Customer Inquiry Procedure

TCM-03 Order Processing Procedure

TCM-04 Handling of External Complaints Procedure

TCM-05 Customer Survey & Feedback Procedure


6.4 EXTERNAL COMMUNICATION PROCESSES

With regard to its environmental aspects, OH&S hazards and IMS, The xyz Sdn. Bhd. had established and
documented a THM-07 Communication Procedure which detailed the methods for receiving, documenting
and responding to relevant communication from external interested parties, such as the Department of
Environment, Department of Safety & Health, customers, vendors, contractors, etc. For those communication
with regards to complaints, there exists a TCM-04 Handling of External Complaints Procedure to ensure all
requirements for communication been addressed.

References:

THM-07 Communication Procedure

TCM-04 Handling of External Complaints Procedure

6.5 CUSTOMER INQUIRY HANDLING PROCESSES

The xyz Sdn. Bhd. had established and documented TCM-02 Handling of Customer Inquiry Procedure, to
govern the mechanism for handling all customer inquiries pertaining to product information, orders and
amendments to orders.

If the inquiries can be fulfilled, they will be further processed per TCM-03 Order Processing Procedure,
including amendments to orders previously established.

References:

TCM-02 Handling of Customer Inquiry Procedure

TCM-03 Order Processing Procedure


6.6 CUSTOMER PROPERTY HANDLING PROCESSES

The xyz Sdn. Bhd. shall exercise care with customer property while it is under the organization’s control,
being used by organization, or under its jurisdiction. The xyz Sdn. Bhd. had identified the following customer
properties where it is committed to exercise control:

Customer Brands

Although considered intellectual property, The xyz Sdn. Bhd. shall not divulge information on existing
customers’ brand names and brand / packaging designs, to any other customers. The organization shall not
pack goods in existing customers’ brands, for other customers. This is to safeguard and protect customers’
rights to their branding and product range in the market, and to discourage other unauthorized distributors
from using these names.

Customer-Supplied Materials

At this moment, there is no customer supplying materials to The xyz Sdn. Bhd. but in the event if this happens
in future, The xyz Sdn. Bhd. shall exercise care with customer-supplied materials, since these materials are not
paid for and do not belong to The xyz Sdn. Bhd.

In the event that there is customer supplied materials, The xyz Sdn. Bhd. shall verify that these materials are
in accordance to correct product description, quantity and quality, during receiving, as per TMM-05 Incoming
Receipt, Verification & Preservation of Internal Purchased Products Procedure. And whenever deemed
necessary, these materials shall be inspected. If, during any stage where the materials are found non-
conforming to requirements, specifications, lost, damaged or otherwise found unsuitable for use, The xyz Sdn.
Bhd. shall report to the customers concerned and maintain records of all correspondence, as well as records of
verifications and inspections. This will be then addressed in the MM-05 Control of Non-Conforming
Purchased Products Procedure.

Customer-Supplied Equipment

At this moment, there is no customer supplying equipment to The xyz Sdn. Bhd. but in the event if this
happens in future, where the customers supply any monitoring, measuring or any other form of equipment,
tools, jigs and fixtures, either free of charge of on loan, The xyz Sdn. Bhd. is liable to ensure these equipment
are adequately:

§ Identified with proper labels, tags or stickers, to provide information on the equipment, including any
calibration status, if applicable.

§ Verified that such items are correct in part number (if applicable), description and functionally acceptable,
and record receipt of these items appropriately.

§ Stored and handled appropriately by authorized personnel, to ensure they are not damaged, deteriorated,
or lost.

The control of customer-supplied equipment, tools, jigs and fixtures, will then be addressed and included in
the TFM-01 Facilities Planning & Control Procedure.

References:

TMM-05 Incoming Receipt, Verification & Preservation of Internal Purchased Products Procedure

TOM-05 Control of Non-Conformities Procedure

6.7 TFM-01 Facilities Planning & Control Procedure


CUSTOMER APPOINTMENT OF VENDORS

The xyz Sdn. Bhd. shall ensure that the materials management processes are controlled for those vendors
appointed by specific customers. It is still the onus of The xyz Sdn. Bhd. to ensure that purchased product
conforms to specified purchase requirements, although the type and extent of control applied to this category
of vendors, are comparatively less stringent. The criteria for approving the initial use and continuing use of
these vendors, vary between vendors as well as the type of products and/or services supplied by them,
depending on the effect of these purchased product and/or services on subsequent product realization or the
final product produced. The different process of approving the use of customer appointed vendors of various
products and services, shall adhere to TMM-01 Vendor Selection & Evaluation Procedure. Records of
approving the use of customer appointed vendors shall be maintained according to this procedure.

All purchasing activities associated with the vendors appointed by customers, shall follow the MM-02
Purchasing Procedure, where appropriate, all purchasing information shall describe:

§ Requirements for approval of product, procedures, processes and equipment

§ Requirements for qualification of personnel

§ Requirements of Integrated Management System

§ Requirements for inspection or verification to be carried out at vendors’ premises, by The xyz Sdn. Bhd.
and/or the customers.

Although appointed by customers, all purchased products delivered by these vendors shall be verified, to
ensure purchased product meets specified purchase requirements. The verification and/or inspection activities
are captured in the MM-04 Incoming Receipt, Verification & Preservation of Purchased Products
Procedure.

References:

TMM-01 Vendor Selection & Evaluation Procedure

MM-02 Purchasing Procedure

MM-04 Incoming Receipt, Verification & Preservation of Purchased Products Procedure


6.8 ORDER PROCESSING PROCESSES

The xyz Sdn. Bhd. shall determine the completeness of the customer's requirements such as:

§ Contractual requirements, including product and delivery requirements

§ Requirements that are not specified by the customer but necessary for fitness for purpose

§ Statutory and regulatory requirements (if applicable) related to the product, country of manufacture or sale

§ Additional requirements

The capability of meeting customers' specifications and delivery requirements shall be reviewed, and resolved
any differences between the contract or order requirements. Upon receipt of orders from customers, planning
schedules for materials and sourcing are generated, issued and tracked for execution to delivery. Any agreed
customer special requirements related to an order will be specified in the planning schedule and document for
execution. Subsequent amendments to the order or contract shall also be agreed and those personnel involved
shall understand the amendments. The changed requirements shall be captured in the relevant scheduling for
materials and product realization. Records of the order or contract are maintained. These had been addressed
in the TCM-03 Order Processing Procedure.

The customer requirements, including any requested changes, shall be reviewed before a commitment to
supply the goods. The customer service shall ensure that all customers' orders are delivered as per schedule
and to ensure products are protected from damage, deterioration and loss. The results of the review and
subsequent follow-up actions shall be recorded.

Verbal Contracts

The xyz Sdn. Bhd. does not accept any verbal contracts or orders given by any customer. All requirements
must be adequately defined in the official orders from customers. Hence, this part of the ISO 9001:2000
Clause 7.2.2 shall be excluded from the IMS.

References:

TCM-03 Order Processing Procedure


6.9 CUSTOMER FEEDBACK PROCESSES

The xyz Sdn. Bhd. obtains and processed customer feedback systematically, both reactively and proactively,
as a means of continual improvement on its products, processes and/or IMS.

Reactive means of obtaining and processing customer feedback would include receiving official customer
complaint, either verbally, in written or during customers’ visits or audits. TCM-04 Handling of External
Complaints Procedure had been established and documented to define requirements for:

§ Reviewing nature of customer complaint.

§ Determining the cause(s) of customer complaint.

§ Evaluating the need for correction, corrective actions and/or preventive actions, depending if the
complaint is justifiable.

§ Determining and implementing those improvement actions, if needed

§ Record results of improvement actions taken

§ Reviewing those improvement actions to ensure they are effective

Other than customer complaints, monitoring of internal performance against set targets, for both quality and
delivery, is also considered a reactively ‘silent’ means of obtaining customer feedback. The need to compile
data pertaining to internal quality and delivery adherence targets, had been documented in the TMS-01
Deployment of Policy, Objectives, Targets & Improvement Programs Procedure.

Apart from being reactive to customer feedback, The xyz Sdn. Bhd. also proactively performs:

§ Matching of sales forecast results against actual sales turnover of existing customers, to identify any
trends in customers’ buying behavior. If orders are increasing, customers can be expected to be satisfied
with services rendered by The xyz Sdn. Bhd. This had been documented in the TCM-01 Marketing
Planning & Forecasting Procedure.

§ Surveys at periodic intervals, to obtain feedback from customers, on their overall perception of the
company’s performances, pertaining to pre-defined factors. These factors include all aspects of customer
requirements, which are essentially needed to be fulfilled and satisfied. This had been addressed in the
TCM-05 Customer Survey & Feedback Procedure. This information obtained from the survey findings
shall be compiled using appropriate statistical techniques, and review during Management Review for
identifying opportunities for continual improvement, to its products, processes and/or IMS.

References:

TCM-04 Handling of External Complaints Procedure


TMS-01 Deployment of Policy, Objectives, Targets & Improvement Programs Procedure
TCM-01 Marketing Planning & Forecasting Procedure
TCM-05 Customer Survey & Feedback Procedure
6.10 CUSTOMER SATISFACTION MEASUREMENT PROCESSES

Based on data obtained from the various sources of customer feedback through the survey as per TCM-05
Customer Survey & Feedback Procedure, The xyz Sdn. Bhd. shall identify the method of computing a
measurable result of customer satisfaction, called Customer Satisfaction Index.

The results of the Customer Satisfaction Index compiled shall be reviewed as per TMS-08 Management
Review Procedure, to identify opportunities for further improvements. The surveys, as well as other
alternative methods of obtaining customer feedback shall be reviewed concurrently, to decide if they remain
suitable and effective.

The Customer Satisfaction Index shall remain as a permanent Objective, to demonstrate full commitment of
The xyz Sdn. Bhd. towards customer satisfaction.

References:

TCM-05 Customer Survey & Feedback Procedure


TMS-08 Management Review Procedure
7.0 MATERIALS MANAGEMENT PROCESSES

7.1 VENDOR CONTROL PROCESSES

The xyz Sdn. Bhd. has established and maintained TMM-01 Vendor Selection & Evaluation Procedure as well
as TMM-02 Purchasing Procedure for carrying out purchasing and assessment to ensure purchased product
and service conforms to the customers' and company's requirements respectively.

The type and extend of methods to control these processes shall be dependent on the effect of the purchased
product and service upon the final product and service.

Supplier performance data shall be compiled and analyzed to identify any trends of poor performances which
require corrective and/or preventive actions as per TMS-09 Corrective & Preventive Actions Procedure and
these performance data shall be subject to review per TMS-08 Management Review Procedure.

References:

TMM-01 Vendor Selection & Evaluation Procedure

TMM-02 Purchasing Procedure

TMS-09 Corrective & Preventive Actions Procedure

TMS-08 Management Review Procedure

7.2 PURCHASING

All purchases which have direct impact on The xyz Sdn. Bhd.'s product quality are controlled and maintained.
The selection of suppliers shall be based on meeting one or more of the following:

§ It is specified in the Approved Supplier List


§ It is the only available supplier
§ Reputable brand or manufacturer of the raw materials.

Upon selection of supplier, purchase for these items – such as raw materials, packaging materials, etc. – are
made only from the approved suppliers. Each purchase document shall clearly define and describe the precise
identification of the product / service ordered.

All purchasing requirements, including those related to the identifiable significant environmental aspects
and/or OHS hazards of goods and services used by the organization that is supplied by suppliers and/or
contractors shall be communicated to the latter via THM-07 Communication Procedure.

Purchasing documents shall be reviewed for adequacy of the specified requirements and approved by the
Finance Director and/or Managing Director prior to release for purchase.

References:

TMM-02 Purchasing Procedure

THM-07 Communication Procedure

7.3 CONTROL OF PURCHASED PRODUCT PROCESSES

Verification of purchased products at supplier's premises by The xyz Sdn. Bhd. and/or customers is not
practices at present. All verification of purchased products are performed at the premises of The xyz Sdn. Bhd.
via TMM-03 Incoming Receipt, Verification & Preservation of Purchased Products Procedure. Any item
found non-conforming to requirements shall be controlled as per TOM-05 Control of Non-Conforming
Purchased Products Procedure.

References:

TMM-03 Delivery Procedure

TMM-05 Incoming Receipt, Verification & Preservation of Internally Purchased Products Procedure

TOM-05 Control of Non-Conformities Procedure


8.0 OPERATIONS MANAGEMENT PROCESSES

8.1 CONTROL OF PRODUCT REALIZATION

In order to carry out its operation as a manufacturer, The xyz Sdn. Bhd. has established and
maintained .................. The process operations are executed under the controlled conditions that include the
following:

§ Ensure availability of information that describes the characteristics of the product (to be supplied to
the customers), through dissemination of:
✔ Specifications of each and every product available for sales to customers;
✔ Certificate of Conformities, or equivalent, issued by the suppliers for each delivery made to the
customers
§ Ensure availability of information that describes the characteristics of the service to be rendered in
order to function as an effective trading house, through dissemination of:
✔ All relevant documented procedures to all concerned employees
§ Ensure availability of work instructions, through inclusion of such work instructions in the
distribution list.
§ Ensure use of suitable equipment through implementation of proper preventive maintenance
programs.
§ Ensure use of monitoring and measurement devices, such as Weighing Scales for monitoring the
weight of the products.
§ Ensure implementation of monitoring activities related to the product realization, via the
requirements as stipulated in all the respective documented procedures.
§ Ensure implementation of measuring activities related to the service realization, via the evaluation on
the achievement of the set measurable Objectives.
§ Ensure implementation of release through proper review of Purchase Orders made to suppliers prior
to delivery to customers.

For these operations and activities, The xyz Sdn. Bhd. had also identified the associated significant
environmental aspects and OH&S hazards, in line with its Policy, and measurable Objectives. There exists a
TOM-03 Environmental, Safety &Health Operational Control Procedure to ensure no deviations from the
Policy and Objectives. Specific procedures had been established and documented to ensure control of
operations in relation to environment and workplace, namely TOM-04 Waste Management Procedure and
OM-09 Chemical Control Procedure.

References:
TCM-02 Handling of Customer Inquiry Procedure

TCM-03 Order Processing Procedure

TMM-02 Sourcing Procedure

TOM-03 Environmental Operational Control Procedure

TOM-04 Waste Management Procedure

8.2 SPECIAL PROCESS

There is no special process where the resultant product / service cannot be verified by subsequent
monitoring or measurement. As such the ISO 9001:2000 Clause 7.5.2 is not applicable.

8.3 EMERGENCY PREPAREDNESS & RESPONSE

The xyz Sdn. Bhd. has established and documented a THM-08 Emergency Preparedness & Response
Procedure to identify potential for and respond to accidents and emergency situations, and for preventing and
mitigating the environmental impacts and/or OH&S risks, that may be associated with them.

The xyz Sdn. Bhd. shall review and revise, where necessary, its emergency preparedness and response
procedure, via the TMS-02 Control of Documents Procedure, in particular, after the occurrence of accidents
or emergency situations.

The xyz Sdn. Bhd. shall also periodically test such procedures where practicable.

References:

THM-08 Emergency Preparedness & Response Procedure

TMS-02 Control of Documents Procedure

8.4 IDENTIFICAITON & TRACEABILITY PROCESSES


The company shall make provision for identifying status of product with respect to required measurement
and verification activities and, where applicable, shall identify the product by suitable means such as contract
numbers, traveler card, etc., throughout all processes. This shall apply to all stages of product realization,
until delivery to the customers, where their interaction affects conformity with requirements.

Traceability of product realization is achieved by the use of the following means:

§ Delivery Order number and date, traceable to respective part number(s);


§ Packing labels, traceable to the respective production lot number(s)
§ Production lot numbers, traceable to the materials lot number(s)

The company shall ensure these unique identifications of product being controlled and recorded.

References:

TCM-03 Order Processing Procedure

TMM-02 Sourcing Procedure

TMM-03 Delivery Procedure

8.5 HANDLING, PACKAGING, STORAGE, PRESERVATION AND DELIVERY

The company shall ensure, for those purchased items which are received by The xyz Sdn. Bhd. and
subsequently sent processed and delivered to the customer, it must exercise control of these goods to ensure
identification, packaging, storage, preservation and handling do not affect conformity with product
requirements.

Proper handling and storage of these materials / products shall be carried out to prevent mixing, damage and
deterioration. Proper storage facilities shall be provided for the storage of materials / products pending use
and to preserve the quality.

The xyz Sdn. Bhd. has established and maintained documented OM-05 Production Process & Control
Procedure and OM-06 CD Manufacturing Process & Control Procedure to ensure product release and
delivery shall not proceed until all the specified activities have been satisfactorily completed and the related
documentation is available and authorized.

References:

TMM-05 Incoming Receipt, Verification & Preservation of Internally Purchased Products Procedure
TMM-03 Delivery Procedure

8.6 MEASUREMENT AND MONITORING OF PROCESSES

The xyz Sdn. Bhd. shall apply suitable methods for measurement and monitoring of its IMS processes
necessary to meet customer requirements and to demonstrate the process' continuing ability to satisfy its
intended purpose. Each of the documented procedures have been established and documented based on the
Plan-Do-Check-Action meaning that specific data is expected to be collected and analyzed against set targets
as per TMS-01 Deployment of Policy, Objectives, Targets and Improvement Programs Procedure.
Measurement results such as customer satisfaction status shall be used to maintain and improve on those
processes.

References:

All Procedures

TMS-01 Deployment of Policy, Objectives, Targets and Improvement Programs Procedure

8.7 MEASUREMENT AND MONITORING OF PRODUCT

The xyz Sdn. Bhd. shall apply suitable methods for measurement and monitoring of the characteristics such
as customer's specifications of the product to verify that requirements for the product are met.

It is the practice of The xyz Sdn. Bhd. that all in-coming, in-process and finished product final inspection and
testing are performed according to documented procedures.

Inspection and testing carried out shall be planned based on the product requirements as well as any
customer specific requirements. The amount of testing shall be stipulated in the documented procedures, as
per MM-03 Incoming Receipt, Verification & Preservation Purchased Products Procedure, OM-02 In-
Process Quality Control Procedure and OM-03 Outgoing Quality Control Procedure, as well as the OM-01-
W01 Control Plan.

Inspection and testing records are kept for all inspection performed. Only lots that accepted are authorized
for shipment.

Inspection and testing status are indicated in the respective records.


References:

MM-03 Incoming Receipt, Verification & Preservation Purchased Products Procedure

OM-02 In-Process Quality Control Procedure

OM-03 Outgoing Quality Control Procedure

8.8 CONTROL OF NONCONFORMITIES

Control of Non-Conforming Products

Non-conforming products encountered in receiving and processing, or for internal use or customer complaint
/ return goods where appropriate are identified, documented, and segregated to prevent unintended use or
delivery.

In The xyz Sdn. Bhd., non-conforming product is controlled according to the documented procedure.
Responsibility and authority for the review and resolving of nonconformities shall be defined.

Action to be taken for these nonconformities is either one of the following:

§ rework to conform to requirements, or


§ accepted under concession, with or without repair, or
§ re-cycled, or
§ rejected as unsuitable.

When required by the contract, the proposed use or repair of non-conforming product shall be reported for
concession to the customer. Non-conforming products which do not meet customer specifications is only
shipped with a written authorized from the customer.

The description of any such rework, accepted non-conforming, product repair shall be recorded. Reworked
and repaired products shall be re-inspected according to documented procedure.

References:

TOM-05 Control of Non-Conformities Procedure

Control of Environmental, Safety & Health Non-Conformities

Whenever there is any deviation from the controls specified, and/or deviation from the legal / regulatory
requirements, these non-conformties shall be investigated, and actions must be taken to mitigate the impact /
risks caused, including any corrective and/or preventive actions.

References:

TOM-05 Control of Non-Conformities Procedure


9.0 REVIEW & IMPROVEMENT

The management of The xyz Sdn. Bhd. shall analyze applicable data generated by measuring and monitoring
activities and other relevant sources to provide information on the following:

§ the suitable, effectiveness and adequacy of the Integrated Management System;


§ process operation trends;
§ customer satisfaction and/or dissatisfaction;
§ conformance to customer requirements; and
§ characteristics of processes, products and services

The above relevant and applicable data will be utilized to determine the effectiveness of the Integrated
Management System and for identifying where improvements can be made.

For the analysis, appropriate statistical techniques or tools may be used to establish, control and verify
process capability, service characteristics and above mentioned information for continual improvement.

The company has established documented procedure that describes the use of Policy, objectives, internal
audit results, analysis of data, corrective and preventive action and management review to facilitate continual
improvement.

Changes into relevant system level procedure(s) resulting from corrective and preventive actions shall be
recorded and maintained.

References:

TMS-01 Deployment of Policy, Objectives, Targets & Improvement Programs Procedure

TMS-08 Management Review Procedure

9.1 MEASUREMENT AND MONITORING OF SYSTEM PERFORMANCE

In The xyz Sdn. Bhd. customer satisfaction is used as one measure of system output and Internal Audit is
also used as a tool for evaluating ongoing system compliance.

The company shall monitor information on customer satisfaction and/or dissatisfaction, in which suitable
methods and measures are used for obtaining and utilizing such information and data.
Internal Audits are scheduled to verified that procedures documented are compliance to applicable standards,
are in compliance practice and the results of practice are effective to the operational and company's intended
purposes. Internal Audit may be carried out to identify potential opportunities for improvement.

The audits are carried out at least once a year and where required specific additional audits may be
scheduled. The audits shall be carried out by trained Internal Auditors that are independent of the activities
being audited.

The findings of the Internal Audit is recorded, issued to the responsible Department head of the area
concerned, who will identify the cause and take appropriate actions for timely implementations.

References:

TCM-04 Handling of External Complaints Procedure

TCM-05 Customer Survey & Feedback Procedure

TMS-06 Internal Audit

9.2 CORRECTIVE ACTION

The xyz Sdn. Bhd. has established and maintained documented procedure for reducing or eliminating the
causes of non-conformity in order to prevent recurrence. The procedure for the corrective action includes the
requirements for:

§ identification of nonconformities which including customer complaints;


§ determination of the causes of nonconformities;
§ evaluation of the need for actions to ensure that nonconformities do not recur;
§ recording the results of actions taken; and
§ reviewing that corrective action taken is effective and recorded.

All required actions taken shall be to a degree appropriate to the magnitude of problem and commensurate
with the risks encountered.

References:

TMS-09 Corrective & Preventive Actions Procedure


9.3 PREVENTIVE ACTION

The company shall establish documented procedure for eliminating the causes of potential nonconformities
to prevent occurrence. Integrated Management System records and results from the analysis of data shall be
used as inputs for preventive action, as applicable. The procedure for preventive action process shall address
the following:

§ identification of potential nonconformities;


§ determination of the causes of the identified potential nonconformities and recording the results;
§ determination of potential nonconformities needed to eliminate causes of potential nonconformities;
and
§ reviewing that preventive action taken is effective and recorded.

All required actions taken shall be to a degree appropriate to the magnitude of problem and commensurate
with the risks encountered.

References:

TMS-09 Corrective & Preventive Actions Procedure

9.4 MANAGEMENT REVIEW

Documented procedure shall be established and maintained for management review. Management Review of
the company is conducted at least once a year; participated all Departmental Heads and chaired by the
Managing Director.

Management Review shall review the Integrated Management System to ensure its continuing suitability,
adequacy and effectiveness. The review shall evaluate the need for changes to the organization's Integrated
Management System, including Policy and Objectives.

The agenda of the Management Review shall include review current performance and improvement
opportunities related to:

§ results of audits;
§ customer feedback;
§ process performance and product conformance analyses;
§ status of corrective and preventive actions;
§ follow-up actions from earlier management review; and
§ any changing circumstances.

The outputs of the management review shall include actions related to :-


§ improvement of the Integrated Management System;
§ process, product improvement; and
§ resource needs.

The results of management review shall be recorded into the meeting minutes and circulated to all
Departmental Heads for follow up implementation and tracking.

References:

TMS-08 Management Review Procedure

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