Professional Documents
Culture Documents
(QMS) Manual
Document Title
Document No xxxx /QMS
Revision No 00
Effective Date 1 December 2016
Reviewed by General Manager
Approved by Managing Director
This document is the exclusive property of XXXX Xxxx Sdn Bhd (XXXX ) and upon request, may
distribute on a confidential basis. Further distribution, copying, reproduction in whatever form is to be
done only with the express permission of XXXX . This document must be returned to XXXX at the
request of XXXX and no copies in whatever form of any part of this document is to be retained without
the permission of XXXX . XXXX will seek recourse should this notice be violated.
Revision History
Rev. No. Page Description Prepared by
No.
0 All New Issue
Contents
1. OVERVIEW OF ORGANIZATION AND QUALITY MANUAL............................................4
1.1 COMPANY BACKGROUND & PROFILE....................................................................4
1.2 SCOPE OF QUALITY MANAGEMENT SYSTEM (QMS) CERTIFICATION......................5
1.3 QUALITY MANUAL OVERVIEW...............................................................................5
2. REFERENCE............................................................................................................. 6
3. GLOSSARY............................................................................................................... 6
4. ORGANIZATION CONTEXT.......................................................................................6
4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT...................................6
4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES......7
4.3 SCOPE OF THE QUALITY MANAGEMENT SYSTEM..................................................7
4.4 QUALITY MANAGEMENTSYSTEM AND ITS PROCESSESS.......................................8
5. LEADERSHIP............................................................................................................ 9
5.1 LEADERSHIP AND COMMITMENT..........................................................................9
5.2 POLICY............................................................................................................... 10
5.3 ORGANIZATION ROLES, RESPONSIBILTY AND AUTHORITY..................................10
6. PLANNING............................................................................................................. 11
6.1 ACTION TO ADDRESS RISKS AND OPPORTUNITY................................................11
6.2 QUALITY OBJECTIVES AND PLANNING................................................................12
6.3 PLANNING OF CHANGE......................................................................................13
7. SUPPORT............................................................................................................... 13
7.1 RESOURCE......................................................................................................... 13
7.2 COMPETENCE.................................................................................................... 17
7.3 AWARENESS....................................................................................................... 18
7.4 COMMUNICATION............................................................................................... 18
7.5 DOCUMENTED INFORMATION.............................................................................19
8. OPERATION........................................................................................................... 22
8.1 OPERATIONAL PLANNING & CONTROL...............................................................22
8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES...............................................23
8.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES..............................24
8.4 CONTROL OF EXTERNALLY PROVIDED, PRODUCTS AND SERVICES....................24
8.5 PRODUCTION PROVISION...................................................................................26
8.6 RELEASE OF PRODUCTS.....................................................................................29
8.7 CONTROL OF NONCONFORMING OUTPUTS........................................................29
9. PERFORMANCE EVALUATION.................................................................................30
9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION..............................30
9.2 INTERNAL AUDIT................................................................................................ 31
9.3 MANAGEMENT REVIEW......................................................................................32
10. IMPROVEMENT...................................................................................................... 33
10.1........................................................................OPPORTUNITY FOR IMPROVEMENT
33
10.2.......................................................NONCONFORMITY AND CORRECTIVE ACTION
34
10.3...................................................................................CONTINUAL IMPROVEMENT
34
11. APPENDICES.......................................................................................................... 35
1. OVERVIEW OF ORGANIZATION AND QUALITY MANUAL
COMPANY ADDRESS
BUSINESS REGISTRATION
Registration CIDB
TOP MANAGEMENT
Managing Director (MD)
General Manager ( GM )
BUSINESS NATURE
Provision of Project Management, Xxxx Works:
Piling, Civil, Structure & Marine Xxxx
Pipeline and Piping Works (Fabrication and Installation)
Task Force and Manpower Supply for Plant Construction
1.2 SCOPE OF QUALITY MANAGEMENT SYSTEM (QMS)
CERTIFICATION
The scope of Quality Management System in XXXX Xxxx Sdn Bhd is
Provision of Project Management, Engineering, Construction and marine
Works. Details of scope boundary and requirements applicability are
discussed in clause 4.3.
NO TERMS DESCRIPTIONS
We depend on our clients, therefore we shall identify,
determine and understand their needs and
1 Customer Focus
expectation in order to meet their requirements and
strive towards client satisfaction.
Management is not an administration activity; and
leadership is needed to provide a unity of purpose,
2. Leadership direction and to create an environment in which
people in the organization become fully involved in
achieving our objectives.
Employee co-operation and involvement allows for
Engagement of
3. their ability to be fully and effectively used for the
People
benefit of the company.
4. Process Approach For the results to be achieved efficiently, the
resources and activities of MOLECOR need to be
managed as a process.
2. REFERENCE
XXXX adopts the ISO 9001:2015 requirements based on the latest
references or revision by members of ISO and IEC maintain registers of
currently valid international standards.
*Refer to ISO 9001:2015, Clause 2 (Normative reference)
3. GLOSSARY
4. ORGANIZATION CONTEXT
4.1 UNDERSTANDING THE ORGANIZATION AND ITS
CONTEXT
XXXX Xxxx has determined external and internal issues that are relevant
to its purpose and its strategic direction and that affect its ability to
achieve the intended result(s) of its Quality Management System.
This company also has considered external issues arising from customer,
legal requirements, suppliers and contractors. Meanwhile, for internal
issues the company may consider issues related to values, culture,
knowledge and performance of the organization.
We determine internal and external issues that might affecting our
Quality Management System and business processes based on 4M1E
elements and also using FITCOW and PESTLE analysis method. We
highlight applicable risk that may arise from these internal and external
issues in risk assessment process.
No Related Documentations
1 Summary of internal and external issues
No Related Documentations
1 Appendix III - Quality Policy
No Related Documentations
1 XXXX /JD Job Description
6. PLANNING
6.1 ACTION TO ADDRESS RISKS AND OPPORTUNITY
When planning for the Quality Management System, XXXX has
considered:
(a) Internal and external issues identified within the organizational
context are addressed;
(b) Requirements of interested parties are addressed;
(c) Compliance obligations;
(d) Risks and opportunities for (a) and (b) are determined;
Risks and opportunities associated with company Operation, interested
parties and legal obligations has been identify and analyzed. The
company is responsible for its application of risk based thinking and the
actions it takes to address the risks. The action plan shall ensure:
Quality management system can achieve its intended result(s);
Enhance desirable effects;
Prevent, or reduce, undesired effects;
Achieve improvements.
We has determined what could go wrong in existing plans and practices.
The problem causes are assessed according to their likelihood of
occurrence and the severity of their consequences.
We consider several options to address the identified risks include
avoiding risk, taking risk in order to pursue an opportunity, eliminating
the risk source, changing the likelihood or consequences, sharing the
risk, or retaining risk by informed decision.
Here in XXXX, preventive actions are taken and contingency plans are
developed to ensure identified risks are in control or at least minimize
their effect if they do occur.
Risk register shall be prepared or updated by the process/risk owner
when:
(a) Completing a plan for implementing a decision or improvement
(b) Monitoring a plan which is in progress
(c) Reacting to possible internal or external changes that could affect
the company
The risk register shall be reviewed yearly and updated upon changes in
the process and service specifications. The process owner shall integrate
and implement action plan into its Quality Management System
processes.
Effectiveness of risk control shall be evaluated, analyzed and reported to
the management during QMS management review meeting.
No Related Documentations
1 XXXX /SP04 Risk Assessment & Control
2 Risk Register & Action Plan
3 Job Safety Analysis
4 HIRARC
No Related Documentations
1 Appendix III XXXX /QM - Quality Objectives
2 QMS Management Program
No Related Documentations
1 XXXX /SP16 Management of Change (MoC)
7. SUPPORT
7.1 RESOURCE
7.1.1 GENERAL
The company shall determine and provide in a timely manner the
resources needed:
(a) To implement and maintain the Quality Management System and
continually improve its effectiveness.
(b) To enhance customer satisfaction by meeting customers
requirements.
(c) The provision of resources shall be reflected in organization chart,
process flow chart and etc.
(d) The Director shall identify the resources needed during new process, new
layout, equipment, environment and new technology required.
7.1.2 PEOPLE
The company determines and provides the persons necessary for the
effective implementation of its Quality management system and for the
operation and control of its processes.
7.1.3 INFRASTRUCTURE
The company shall identify, provide and maintain the facilities it needs to
achieve the conformity of products and services, including maintaining of
buildings, workspace and associate utilities. The office and work area
shall be safe and of good housekeeping practices.
All installed equipment which required maintenance (including of
software/ information system, if any) shall be periodical serviced and
maintained as per schedules. The company shall identify, provide and
maintain the infrastructure for the operation of its processes and to
achieve the conformity of our services, including, as applicable:
(a) Building and associated utilities;
(b) Process equipment (both hardware and software) such as machine,
measuring equipment for testing, storage etc.
(c) Transportation resources (company vehicles)
(d) Information and communication technology
We plans and performs the periodic maintenance on the infrastructures
required for maintaining the effectiveness of the quality management
system. Planning of maintenance shall be based on:
Criticality of infrastructures
Frequency of usage
Suitability of the infrastructures
Regulatory requirements (e.g. DOSH, DOE)
No Related Documentations
1 XXXX /SP12 Infrastructure & Environment
No Related Documentations
1 XXXX /SP12 Infrastructure & Environment
2 HSE Policies
3 HSE Manual
No Related Documentations
1 XXXX/SP13 Calibration
7.2 COMPETENCE
XXXX is committed to the ongoing development of employees. High
performance and continuous commitment is expected from all
employees. Competency of employees which affects the performance
and effectiveness of the quality management system shall be taken into
account.
Training Needs Assessment is periodically conducted to identify training
needs among employees. Training shall be provided to the employees in
order for them to acquire the necessary competence and included as
part of their personal training plan.
The company Training System can be implemented through a series of
processes which include:
(a) On job training
(b) Soft skills/ Management Development Training
(c) Other Technical/ Engineering Skills Training Process
This is to ensure that employees are trained and knowledgeable in their
safety responsibilities, nature of the hazards and the actions necessary
to safely perform their jobs. Based on training needs analysis, Training
Plan will be established which covers the mandatory and relevant
training and also relevant personnel who needs to attend.
The Training Plan is reviewed / updated on an annual basis with
endorsement from PDR Management. Training evaluation is carried out
to verify the effectiveness of the training via:
(a) Training Feedback & Evaluation forms
(b) Performance appraisal
No Related Documentations
1 XXXX /SP06 Recruitment
2 XXXX /SP07 Training
7.3 AWARENESS
The company shall ensure all employees (and where applicable
contractors) are aware of:
(a) Conformance with the Quality policy, procedures and Management
System requirements
(b) The significant quality specification, health & safety hazards,
environmental effects associated with their work activities and the
benefits of improved personnel performance
(c) Roles and responsibilities in achieving conformance with the Quality
policy, procedures and Management System requirements
(d) The potential consequences of deviation from specified operating
procedures
No Related Documentations
1 XXXX /SP06 Recruitment
2 XXXX /SP07 Training
7.4 COMMUNICATION
The company shall determine the internal and external communications
relevant to the quality management system, including on what it will
communicate; when to communicate; with whom to communicate; how
to communicate; and who communicates.
Internal communication shall be in place to discuss on the performance
of quality management system such as:
(a) Business planning (company Top management meeting)
(b) Performance of company is communicated during weekly, monthly,
quarterly, and QMS management review)
(c) Safety, health and environmental related issues is communicated
during Toolbox meeting, Monthly meeting, QMS management review)
(d) Changes/ update on the requirements of interested parties (e/g:
customer, government bodies, contractors, etc.) QMS management
review
(e) Results of internal or external assessment are communicated during
QMS management review)
LEVEL
1-
MANU
AL
LEVEL 2 - STANDARD
PROCEDURES
8. OPERATION
8.1 OPERATIONAL PLANNING & CONTROL
The company shall plan, implement and control the processes needed to
meet the requirements for the provision of products, and to implement
the actions determined in Clause 6, by:
(a) Determining the requirements for the products (e/g: service
requirements, In-full and timeliness of delivery)
(b) Establishing criteria for the processes and the acceptance of products
based on applicable requirements (e/g: requirements defined by
customer, government body);
(c) Determining the resources needed to achieve conformity to the
product requirements;
(d) Implementing control of the processes in accordance with the criteria;
(e) Determining, maintaining and retaining documented information to
the extent necessary:
(f) to have confidence that the processes have been carried out as
planned;
(g) to demonstrate the conformity of products to their requirements.
(h) Control planned changes and reviews the consequences of
unintended changes, taking action to mitigate any adverse effects, as
necessary.
(i) Control outsourced processes. The type and extent of control or
influence to be applied to the process(es) shall be defined within the
environmental management system.
No Related Documentations
1 XXXX/SP08 Tender Process
2 XXXX/SP09 Project Management & Control
3 Quality Manual
No Related Documentations
1 XXXX/SP08 Tender Process
2 XXXX/SP09 Project Management & Control
No Related Documentations
1 XXXX/SP10 Procurement Control
2 XXXX/SP11 Control of External Provider
No Related Documentations
1 XXXX/SP08 Tender Process
2 XXXX/SP09 Project Management & Control
3 XXXX/SP14 Drawing Control
4 Method Statement Master List
5 Job Safety Analysis (JSA)
6 Quality Manual
No Related Documentations
1 XXXX/SP08 Tender Process
2 XXXX/SP09 Project Management & Control
3 Quality Manual
8.5.3 PROPERTY BELONGS TO CUSTOMER OR EXTERNAL
PROVIDER
The Project team shall exercises care with customer or external
provider property while it is under our control or being used.
Customer or external provider property provided for use or
incorporation into the product or services will be suitably identified,
verified, protected and safeguarded.
Any customer or external provider property that is lost, damaged, or
otherwise found to be unsuitable for use will be recorded and
reported to the customer.
No Related Documentations
1 XXXX/SP09 Project Management & Control
2 XXXX/SP15 Customer Satisfaction
3 Quality Manual
8.5.4 PRESERVATION
The incoming materials and goods are stored at the designated area
to avoid from wet or damaged. There is no material which is
sensitive to the climate and stored directly under sunlight.
There are additional preservation requirements to the goods during
delivery to the customer. Goods are stored in a covered warehouse.
The details about handling, storage, preservation of the raw
materials and finished goods are defined in the relevant procedure .
No Related Documentations
1 XXXX/SP09 Project Management & Control
2 XXXX/SP05 Continual Improvement
3 Quality Manual
No Related Documentations
1 XXXX/SP08 Tender Process
2 XXXX/SP09 Project Management & Control
3 XXXX SP15 Customer Satisfaction
4 Quality Manual
No Related Documentations
1 XXXX/SP08 Tender Process
2 XXXX/SP09 Project Management & Control
3 Quality Manual
No Related Documentations
1 XXXX/SP09 Project Management & Control
2 Quality Manual
No Related Documentations
1 XXXX/SP09 Project Management & Control
2 XXXX/SP05 Continual Improvement
3 Quality Manual
9. PERFORMANCE EVALUATION
No Related Documentations
1 XXXX/SP15 Customer Satisfaction
2 Complaint record
3 Customer NCR
No Related Documentations
1 XXXX /SP02 Internal Audit
The MRT shall ensure necessary information or review input are collected
to allow the team to analyse the current performance or evaluation
related to the following:
(a) status of actions from previous management reviews;
(b) changes in external and internal issues that are relevant to the
Quality Management System including change on legal or process;
(c) Review on objectives and targets including progress of programme;
(d) information on the performance and effectiveness of the Quality
Management System, including trends in:
i. customer satisfaction and feedback from relevant interested
parties;
ii. the extent to which Quality objectives have been met;
iii. process performance and conformity of products and services;
iv. nonconformities and corrective actions;
v. monitoring and measurement results;
vi. audit results;
vii. performance of external providers;
(e) adequacy of resources;
(f) effectiveness of actions taken to address risks and opportunities
(g) Recommendations for improvements
The review shall be recorded and kept for at least 3 years. Any plan
changes shall be managed according to procedure Management of
Change (MoC).
No Related Documentations
1 XXXX /SP03 Management Review
10. IMPROVEMENT
10.1 OPPORTUNITY FOR IMPROVEMENT
XXXX shall determine and select opportunities for improvement and
implement any necessary actions to meet customer requirements and
enhance customer satisfaction. These shall include:
(a) Improving products quality or delivery to meet requirements as well
as to address future needs and expectations;
(b) Correcting, preventing or reducing undesired effects;
(c) Improving the performance and effectiveness of the Quality
management system
10.2 NONCONFORMITY AND CORRECTIVE ACTION
XXXX shall take action to eliminate the cause of non-conformities in
order to prevent recurrence. It shall be appropriate to the effects of the
non-conformities encountered.
The procedure defines the requirements for:
(a) Reviewing non-conformities (including client complaints).
(b) Determining the causes of non-conformities.
(c) Evaluating the need for action to ensure that non-conformities do not
reoccur.
(d) Determining and implementing action needed.
(e) Records results of action taken.
(f) Reviewing corrective action taken.
No Related Documentations
1 XXXX/SP05 Continual Improvement
11. APPENDICES LIST
APPENDIX 1 - Organization Chart
APPENDIX II - Mission & Vision
APPENDIX III - Quality Policy
APPENDIX IV - Quality Objectives
APPENDIX V - QMS Processes Interaction
Vision
Misson
Approved by
.
Managing Director
XXXX XXXX SDN BHD
DATE: 1st December 2016
APPENDIX IV - Quality Objectives
Approved by
Managing Director
XXXX XXXX SDN BHD
DATE: 1st December 2016