Quality Management System(QMS) Manual Quality Management System Company Manual Document Title Document No xxxx /QMS Revision No 00 Effective Date 1 December 2016 Reviewed by General Manager Approved by Managing Director MASTER CONTROLLED COPY UNCONTROLLED COPY Company Document No : xxxxx /QM Manual Page No : 2 of 41 Revision No. : 00 Quality Management Effective Date : 1 Dec System 2016 Title: QMS Manual 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 1.1 COMPANY BACKGROUND xxxx Xxxx SDN BHD is an international certified company with project locations across Asia and operates through its affiliates companies such as xxxx Offshore Services, xxxx Oil Field Services and xxxx OFFSHORE SDN BHD. xxxx Xxxx has completed numerous projects successfully in the past with compliance of HSE and Quality requirement. Our Company expertise in: 1. Geotechnical, Piping, Civil, Structure & Marine Xxxx 2. Offshore Pipeline Commissioning, Process Plant Commissioning, Start Up and Offshore Hook-Up and Commissioning 3. Tank Construction Works (API 650) Std 4. Blasting & Painting and Insulation Works 5. Project Management Services/Task Force Manpower Supply for Plant Construction 6. Crude Tank & Petrochemical Tank Cleaning Works 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 therefore we shall identify. The QMR is responsible to review the QMS Manual when changes occur to reflect current technology. Process Approach For the results to be achieved efficiently. Construction and marine Works. determine and understand their needs and 1 Customer Focus expectation in order to meet their requirements and strive towards client satisfaction. XXXX has adopted the 7 principles of Quality Management that have been incorporated into a Quality Management System designed to conform to the requirements.1. (“XXXX ”). legal requirements.2 SCOPE OF QUALITY MANAGEMENT SYSTEM (QMS) CERTIFICATION The scope of Quality Management System in XXXX Xxxx Sdn Bhd is Provision of Project Management. Details of scope boundary and requirements applicability are discussed in clause 4. Leadership direction and to create an environment in which people in the organization become fully involved in achieving our objectives. changing customer expectations and improvements to the Quality Management System. their ability to be fully and effectively used for the People benefit of the company. Employee co-operation and involvement allows for Engagement of 3. 1. Maintenance and issuance of this Quality Manual are in accordance with Control of Documented Information Procedure. implementation and maintenance of the Quality Management System. Management is not an administration activity.3 QMS MANUAL OVERVIEW This QMS Manual was developed in accordance with the International Standard: ISO 9001:2015 Quality Management System – Requirements The QMS Team Leader / Management Representative (QMR) has established this QMS Manual in consultation with all department and management of the XXXX Xxxx Sdn Bhd.3. Engineering. and leadership is needed to provide a unity of purpose. the resources and activities of MOLECOR need to be . NO TERMS DESCRIPTIONS We depend on our clients. 4. 2. The objective of this QMS manual is to specify the requirements for the development. 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. Clause 2 (Normative reference) 3. electronic or optical computer disc. legal requirements and QMS requirements. Decision Making intuitive analysis of data and factual information. QMR : QMS Team Leader / Management Representative QMS : Quality Management System 4. photograph or master sample. ORGANIZATION CONTEXT 4. procedures. practices. GLOSSARY Company : XXXX Xxxx Sdn Bhd. *Refer to ISO 9001:2015. or a combination thereof Supplier : The party who supplies goods and services to XXXX HOD : Head of Department Individual or group concerned with or affected by the Interested party : Integrated performance of an organization Non-fulfilment of a requirement that can be any deviation Non Conformity : from relevant work standards. information : magnetic.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. (“”) Customer : The party who receives goods and services from XXXX Documented Information and its supporting medium that can be paper. managed as a process. 2. 5. Improvement Is a permanent objective of XXXX Xxxx Sdn Bhd Evidence –based Effective decisions are based on the logical and 6. . Management create value. Such relationship between the organization and its Relationship suppliers enchance the ability of both organization to 7. No Related Documentations 1 Summary of internal and external issues 4. knowledge and performance of the organization. Meanwhile. On time team project completion 2 Suppliers and Lead time. quantity. The Company ensures the needs and expectations of the interested parties are fulfilled in order to support its quality management system. Interested parties that are relevant to XXXX are (but not limited to): N Interested Needs and Expectation Monitoring by o Parties 1 Customer Service meet requirements & Director & Project applicable standards. for internal issues the company may consider issues related to values. culture. (b) Requirements of these interested parties that are relevant to the QMS. This company also has considered external issues arising from customer.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES In order for the Company to consistently provide products and services that meet customer and applicable statutory and regulatory requirements. We highlight applicable risk that may arise from these internal and external issues in risk assessment process. suppliers and contractors. legal requirements. Responsibility is assigned to monitor and review information about the interested parties and their requirements. we have determined: (a) Interested parties that are relevant to the Quality Management System. 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. contract Purchaser & Contractors/ Others Project team 3 Communities / Safe environment Safety Officer & Neighbours Project team 4 Government bodies Comply to applicable standards HSE Manager . Our Quality Management System include all our business processes such as Human Resources and Administration. (2)ISO 9001: 2015 Clause 8. For this purpose. Any design used in a project will be provided by our customer.3 SCOPE OF THE QUALITY MANAGEMENT SYSTEM The Company has determined the boundaries and applicability of the Quality Management System when establishing its scope for QMS.3 (Design and development of products and services). products and services (e) ability and authority to exercise control XXXX has decided that the scope of our Company Quality Management System Provision of Project Management. Justification: This is due to the fact that we do not undertake any design and development activities that lead to the completion of our products and services. .1 (f) (Validation. health and HODs safety 6 Board of Director Profit and company growth HODs 4. services and customers and regulatory requirements. the company has considered: (a) external and internal issues (b) requirements of relevant interested parties (c) compliance obligations (d) activities. where the resulting output cannot be verified by subsequent monitoring or measurement. Justification: This is due to the fact that the resulting output of our works can be verified by subsequent monitoring or measurement. of the ability to achieve planned results of the processes for production and service provision. products. Maintenance and Engineering works. The requirements of ISO 9001:2015 standard that do not apply to our organization are: (1)ISO 9001: 2015 Clause 8. For this purpose. Project Management and Control. etc) and legal requirements 5 Employees Job security. Xxxx Works. DOSH. QMS Team Leader (QMR) and the Top management have identified the requirements of ISO 9001:2015 that are not applicable to the scope of our quality management system. welfare. (DOE. The Quality Management System is develop to be relevant to the nature of our organization.5. Procurement process. and periodic revalidation. To implement this Quality Management System.4 QUALITY MANAGEMENTSYSTEM AND ITS PROCESSESS The Company adopts the ISO 9001:2015 requirement as the principle for designing this Quality Management System (QMS). nor absolves us from the responsibility. However. documenting. implementing. complexity and interaction of the processes and competence of our personnel. 4. The extent of this Quality Management System (QMS) established is based on the nature of our organization. We: - (a) Determines the processes needed for the quality management system and their application throughout the organization (see Appendix V– business process mapping). The Top Management fully supports and gives fullest commitment in establishing. (d) Determines criteria and methods required to ensure effective operation and control of these processes (see Clause 8). (e) Determines resources needed for these processes and ensure their availability (see Clause 7) (f) Assigns the responsibilities and authorities for these processes (see Clause 5) (g) Addresses risks and opportunities as determined in accordance with the requirements of clause 6. . (b) Determines the inputs required and the outputs expected from these processes (c) Determines the sequence and interaction of these processes (see Appendix V . maintaining and continual improvement of this Quality Management System in accordance with the ISO 9001:2015 requirements.business process mapping).1 (h) Evaluates these processes and implements any changes needed to ensure they achieve their intended results (see Clause 9) (i) Improves the processes and Quality management system (see Clause 10) (j) Maintains documented information to support the operation of its processes (see Clause 7) (k) Retains documented information to have confidence that the processes are being carried out as planned (see Clause 7). to provide product that meets customers and applicable regulatory requirements. these non-applicability shall not affect our ability. 1. (f) Communicating to the employees the importance of effective Quality management system and conforming to the ISO 9001 system requirements.1 LEADERSHIP & COMMITMENT FROM TOP MANAGEMENT The Top management demonstrates leadership and commitment to the development and improvement of the Quality Management System by: - (a) Taking accountability for the effectiveness of the Quality management system. (b) Ensure establishment of the QMS Policy and QMS Objectives and are compatible with the context and strategic direction of the organization. understood and consistently met.1 LEADERSHIP AND COMMITMENT 5.1. (i) Promoting continual improvements. direct and support persons to contribute to the effectiveness of the Quality management system. (b) The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed. (d) Promoting the use of process approach and risk-based thinking. (h) Engage. (c) Ensure integration of the Quality management system into the company business operations. (c) The focus on enhancing customer satisfaction is maintained. (j) Support other relevant management roles to demonstrate their leadership as it applies to their area of responsibilities. 5.5.2 CUSTOMER FOCUS The Top Management demonstrates leadership and commitment with respect to customer focus by ensuring that: (a) Customer and applicable statutory and regulatory requirements are determined. (g) Ensure Quality management system achieves its intended result. (e) Ensure the availability of necessary resources. LEADERSHIP 5. . 3 ORGANIZATION ROLES. employees intended outputs Reporting on the performance of the quality QMR. The policy includes commitment to comply with all relevant legal and other requirements. No Related Documentations 1 Appendix III . Company quality objectives. The policy and objectives for QMS has been rolled out to all employees for their awareness and understanding. RESPONSIBILTY AND AUTHORITY Roles. The Top Management ensures that following responsibilities and authorities are carried out adequately: Descriptions of Responsibilities Responsibility Ensuring that the quality management system Quality Management conforms to the requirements of ISO 9001: 2015 Representative (QMR) Ensuring that the processes are delivering their HODs. and continual improvement of XXXX ’s overall performance. The policy is documented. responsibilities and authorities of the employees within the quality management system are defined in the Job Description. products and services of the company. The Policy is relevant to all activities related to Quality Management System. The policy provides the framework for and is supported by objectives and targets. The policy has been formally approved for its release by the Top Management. The policy is also available to the public and interested parties.5. Internal management system on opportunities for auditor improvement and on the need for change or .2 POLICY A Quality Management System (QMS) Policy statement has been defined and documented. The policy is reviewed annually as part of the QMS Management Review to ensure that it continues to reflect the activities.Quality Policy 5. and that its achievements are quantified where possible. implemented and maintained at all levels throughout the company and communicated to all employees. . undesired effects. The problem causes are assessed according to their likelihood of occurrence and the severity of their consequences. Achieve improvements. The action plan shall ensure: Quality management system can achieve its intended result(s). system is maintained when changes to the quality Management management system are planned and implemented No Related Documentations 1 XXXX /JD Job Description 6. (b) Requirements of interested parties are addressed. taking risk in order to pursue an opportunity. and especially for reporting to top management Ensuring the promotion of customer focus throughout Top Management the company Ensuring that the integrity of the quality management QMR. Descriptions of Responsibilities Responsibility innovation. Prevent. Risks and opportunities associated with company Operation. or retaining risk by informed decision. changing the likelihood or consequences. (d) Risks and opportunities for (a) and (b) are determined. Enhance desirable effects. sharing the risk. We consider several options to address the identified risks include avoiding risk. eliminating the risk source. or reduce. interested parties and legal obligations has been identify and analyzed. (c) Compliance obligations. The company is responsible for its application of risk based thinking and the actions it takes to address the risks.1 ACTION TO ADDRESS RISKS AND OPPORTUNITY When planning for the Quality Management System. PLANNING 6. We has determined what could go wrong in existing plans and practices. DC. XXXX has considered: (a) Internal and external issues identified within the organizational context are addressed. 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. Effectiveness of risk control shall be evaluated. The company has also periodically monitors and evaluates . The objectives and targets are quantified wherever practicable and where appropriate taken into account all preventative measures. communicated and updated. levels and processes within the organization. the applicable legal regulations and the views of interested parties. 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. responsibilities and target of completion for every quality objectives established. financial. Top management has established the KPI at relevant functions. The QMR shall ensure quality objectives are monitored. analyzed and reported to the management during QMS management review meeting. The objectives and targets are consistent with the Quality policy including the company’s commitment to enhance customer satisfaction. operational and business requirements.2 QUALITY OBJECTIVES AND ITS PLANNING Quality objectives and subsequent targets are established after consideration of risks of company’s activities. continual improvements and compliance with applicable requirements. Here in XXXX. The process owner shall integrate and implement action plan into its Quality Management System processes. We shall determine actions to be done. resources and supports required. No Related Documentations 1 XXXX /SP04 Risk Assessment & Control 2 Risk Register & Action Plan 3 Job Safety Analysis 4 HIRARC 6. 1 RESOURCE 7.1. (b) To enhance customer satisfaction by meeting customers’ requirements. . Action plan shall be recorded in the QMS Management Program. new layout. No Related Documentations 1 XXXX /SP16 Management of Change (MoC) 7. (d) the allocation or reallocation of responsibilities and authorities. (b) the integrity of the Quality management system. SUPPORT 7. equipment. No Related Documentations 1 Appendix III XXXX /QM .Quality Objectives 2 QMS Management Program 6. Progress and achievement of Quality Objectives will be reported and reviewed during QMS management review meeting. environment and new technology required. process flow chart and etc.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. (c) the availability of resources. (c) The provision of resources shall be reflected in organization chart. the quality objectives achievements. (d) The Director shall identify the resources needed during new process. XXXX shall carry out the changes in a planned manner by considering: (a) the purpose of the changes and their potential consequences.3 PLANNING OF CHANGE When the company determines the need for changes to the Quality management system. Appropriate actions shall be taken if the Quality Objectives are not achieved. DOE) No Related Documentations 1 XXXX /SP12 Infrastructure & Environment 7. including. psychological and . DOSH. if any) shall be periodical serviced and maintained as per schedules.1. provide and maintain the infrastructure for the operation of its processes and to achieve the conformity of our services.4 WORK ENVIRONMENT The company shall determine. provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.7. measuring equipment for testing. 7. workspace and associate utilities. The company shall identify. (b) Process equipment (both hardware and software) such as machine.1. The office and work area shall be safe and of good housekeeping practices.3 INFRASTRUCTURE The company shall identify. as applicable: (a) Building and associated utilities. All installed equipment which required maintenance (including of software/ information system. provide and maintain the facilities it needs to achieve the conformity of products and services. including maintaining of buildings.g. (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.1. storage etc. The Company shall identify and manage the social. Planning of maintenance shall be based on: Criticality of infrastructures Frequency of usage Suitability of the infrastructures Regulatory requirements (e.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. - (a) Work methods. The company shall ensure that the measuring and monitoring equipment provided are: (a) Suitable for the specific type of monitoring and measurement activities being undertaken.physical factors of the work environment needed to achieve service and process conformity to requirements through implementation of 5S practice. (b) Maintained to ensure their continuing fitness for their purpose.- (a) Heat. The human factors considered are. (c) Retain appropriate documented information as evidence of fitness for . “Drug & Alcohol Policy”. and (e) Pollution.5 MEASURING AND MONITORING EQUIPMENT The company shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. We endeavours to provide safe and healthy working environment to its employees and contractors and surrounding communities with adherence to several policies such as “HSE Policy“. Safety practice and other management system. The relevant work environment will be specified in the relevant work instructions. The physical factors considered are. (c) Hygiene. induction course or on-job training. (b) Light. and (c) Ergonomics. (d) Cleanliness.1. No Related Documentations 1 XXXX /SP12 Infrastructure & Environment 2 HSE Policies 3 HSE Manual 7. (b) HSE procedures. “Stop Work Policy”. The organizational knowledge can be based on internal (such as intellectual property. at specified intervals. against measurement standards traceable to international or national measurement standards. the results of improvements in processes. Where internal calibration is not possible. damage or deterioration that would invalidate the calibration status and subsequent measurement results. No Related Documentations 1 XXXX/SP13 Calibration 7. (c) Safeguarded from adjustments.1. which are traceable to national or international standards. products and services) and external sources (such as . or is considered by the company to be an essential part of providing confidence in the validity of measurement results. When measurement traceability is a requirement. an approved in house calibration will be utilized. Monitoring and measuring equipment used to verify compliance are subjected to regular calibration checks. (b) Identified in order to determine their status. Equipment is allocated with a unique reference number and are checked against the master references. Equipment user shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose. the basis used for calibration or verification shall be retained as documented information. All inspection and test equipment used to verify compliance will be utilized in an environment controlled to the extent necessary to ensure continued measurements of the required accuracy. Records of calibration results are maintained. or both. and shall take appropriate action as necessary. knowledge gained from experience. where applicable. measuring equipment shall be: (a) calibrated or verified.6 ORGANIZATIONAL KNOWLEDGE The company determines the knowledge necessary for the operation of its processes and to achieve conformity of products and services. purpose of the monitoring and measurement resources. when no such standards exist. or prior to use. Calibrated equipment are fixed with a label indicating the validity for use. capturing and sharing undocumented knowledge and experience. lessons learned from failures and successful projects. Competency of employees which affects the performance and effectiveness of the quality management system shall be taken into account. we retain documented information related to experience and lessons learned from failure or nonconformity incident. standards. gathering knowledge from customers or external providers). Based on training needs analysis. nature of the hazards and the actions necessary to safely perform their jobs. In order to maintain organizational knowledge within the company. Training Plan will be established which covers the mandatory and relevant training and also relevant personnel who needs to attend. 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. 7. No Related Documentations 1 XXXX /SP06 Recruitment . 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. academia. skills and values will be assessed and any improvements needed to meet job requirements will be identified and included in the Employee Training record. conferences. Training evaluation is carried out to verify the effectiveness of the training via: (a) Training Feedback & Evaluation forms (b) Performance appraisal The employee performance and competency which include job knowledge.2 COMPETENCE XXXX is committed to the ongoing development of employees. The Training Plan is reviewed / updated on an annual basis with endorsement from PDR Management. High performance and continuous commitment is expected from all employees. 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. Internal communication shall be in place to discuss on the performance of quality management system such as: (a) Business planning (company Top management meeting) . health & safety hazards. (b) Quality policy and objectives are displayed at various strategic areas.4 COMMUNICATION The company shall determine the internal and external communications relevant to the quality management system. procedures and Management System requirements (d) The potential consequences of deviation from specified operating procedures Awareness and understanding being promoted through several platforms: (a) Communication on the policy and objectives during induction program. how to communicate. 2 XXXX /SP07 Training 7. including on what it will communicate. No Related Documentations 1 XXXX /SP06 Recruitment 2 XXXX /SP07 Training 7. with whom to communicate. when to communicate. (c) Ongoing quality/ training programs The potential consequences of deviation from processes is shared via several means. and who communicates.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. reference number). (b) Appropriate format of document is used. health and environmental related issues is communicated during Toolbox meeting. Monthly meeting. contractors. QMS management review) (d) Changes/ update on the requirements of interested parties (e/g: customer.5. organizational rules in relevant to quality management system (b) Communication with supplier (c) Communication with customer including response to enquiries. author. External communication includes (but not limited to): (a) Briefing to contractors regarding organizational policies. (b) Documented information determined by PDR as being necessary for the effectiveness of the Quality Management System.) QMS management review (e) Results of internal or external assessment are communicated during QMS management review) The company ensures communication processes enable persons doing work under the organization’s control to contribute to continual improvement. and QMS management review) (c) Safety. review and approval authority.1 Creating and Updating The company’s quality management system documentation is maintained and controlled respective department. government bodies. quarterly.5 DOCUMENTED INFORMATION XXXX ’s quality management system documentation structure shall include: (a) Documented information required by ISO 9001:2015 Standard. (a) Document is properly identified and described with a title. contract. etc. (c) Document is reviewed and approved for suitability and adequacy . monthly. date. revision number. complaint and feedback 7. (b) Performance of company is communicated during weekly. 7. products and services. Level 3: Method Statement / Inspection testing plan (ITP) / test protocol provide specific instructions on tasks and specifies clearly the acceptance criteria (meeting tolerance limits etc). DRAWING Level I: The QMS Manual addresses XXXX’s quality management of its activities. This manual describes the core elements of the Management System and their interaction. Level 2: Standard procedures is a documented work process that describes the organization’s interfaces between different sections or departments.FORMS. prior to issuance (d) Document is periodically reviewed within stipulated period. .STANDARD PROCEDURES LEVEL 3 .METHOD STATEMENT(MS) LEVEL 4 . RECORDS. and updated as necessary Structure of the quality management system is shown below: LEVEL 1- MANU AL LEVEL 2 . responsibility and authority of a position. including satisfying the ISO 9001:2015 requirements as well as meeting the needs of the organizations. Job description manual describes roles. (d) Control of changes such as: Identify the current revision status of documents. and it is adequately protected (e.5. readily identifiable and retrievable. (c) Quality records are well classified and labelled clearly for easy retrieval and stored in proper storage areas and/or other medium to prevent lost and damages. or loss of integrity).2 Control of Documented Information The company shall control documented information required by the Quality management system and ISO 9001:2015 Standard to ensure it is available and suitable for use. Storage and preservation. Retention period for these records are specified in the Form & Record Master List. The Quality Management System Documents established to meet ISO 9001:2015 requirements are controlled documents. access. After the specified retention period. . maintain and dispose of quality records. these includes level 1 to level 4 of documents. 7. where and when it is needed.g. as applicable: (a) Distribution. (i) Documented information retained as evidence of conformity shall be protected from unintended alterations. file. product and process quality. from loss of confidentiality.Level 4: Records and checklists are formats designed for demonstrating conformance to the quality system. (h) Document controller shall ensure document of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and controlled. (b) Documented information shall remain legible. Relevant versions of applicable documents are available at points of use (e) To prevent the unintended use of obsolete documents (f) Retention and disposition (g) The respective personnel shall be responsible to collect. improper use. The company shall address the following activities to control the documented information. retrieval and use of documented information. including preservation of legibility. store. the records shall be disposed unless otherwise required. XXXX has established implemented and maintained procedures to identify potential for and respond to incidents and emergency situations. taking action to mitigate any adverse effects. implement and control the processes needed to meet the requirements for the provision of products. implement and maintain a procedure for on-going identification for: . 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. (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. The type and extent of control or influence to be applied to the process(es) shall be defined within the environmental management system. (d) Implementing control of the processes in accordance with the criteria. and to implement the actions determined in Clause 6. (i) Control outsourced processes. and for preventing and mitigating the HSE hazards/risks/impacts that may be associated with them. No Related Documentations 1 XXXX/SP01 Control of Documented Information 2 XXXX/SP14 Drawing Control 8.1 OPERATIONAL PLANNING & CONTROL The company shall plan. as necessary. Where appropriate for a project. by: (a) Determining the requirements for the products (e/g: service requirements. government body). XXXX shall establish. (h) Control planned changes and reviews the consequences of unintended changes. (c) Determining the resources needed to achieve conformity to the product requirements. OPERATION 8. 2 REQUIREMENTS FOR PRODUCTS AND SERVICES Project team leader shall make proper arrangements for communication with Customer relating to products/service information. etc) (b) Enquiries (c) Customer feedback/ perception towards products and its delivery (d) Complaints (e) Contingency action to prevent disruption to the operation and delivery Head of Operation is responsible to review the requirements for products and services required by the customers prior committing to supply the products and services to the customer. and expected completion /handover (b) Requirements not stated by the customer. production processes. emails and feedback form. new or modified activities. The review is carried out to assess the capability of the company and project team to meet the requirements. Following requirements are reviewed to ensure resources of XXXX are adequate for the provision of products: (a) Customer requirements such as service requirements. products and services that we can control and influence for planned or new development. products and services). (b) Identification of job safety hazards. but necessary for the specified or intended use. risk assessment and determining control measures to reduce the risks level. acceptance criteria. No Related Documentations 1 XXXX/SP08 Tender Process 2 XXXX/SP09 Project Management & Control 3 Quality Manual 8. new crude processing. enquiries and Customer feedback & complaints through meeting. Project Manager being the centre point of contact shall maintain effective communication with the customer regarding: (a) Information related to products and production (e/g: product specification. (a) Identification of environmental aspects and evaluation of impacts (activities. product nonconformity. when known . is provided by an external provider as a result of a decision by Company Management . XXXX is committed to apply stringent controls onto externally provided. protection of environment. Due to the nature of its operation and product that it supplies. (b) A process. (c) Requirements of the organization (such as those requirements related to cost control.3 DESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES This requirement is not applicable for XXXX and its Quality Management System due to its scope of operation that does not involve any design and development activities. Changes to requirements for products and services are communicated by the customer to Head of Operation or Project Team Leader. Head of Operation is responsible to communicate the confirmation of provision of products and services to the customer.4 CONTROL OF EXTERNALLY PROVIDED. safety. or part of a process. PRODUCTS AND SERVICES The company shall ensure that externally provided products and services conform to requirements in order to assure an effective and efficient quality management system. No Related Documentations 1 XXXX/SP08 Tender Process 2 XXXX/SP09 Project Management & Control 8. products and services. Any deviation to the approved initial plan is being reviewed and approved by XXXX Management. Head of Operation is responsible to notify such changes to Project Team members and/ or relevant interested parties. Work plan shall be revised accordingly (if necessary). etc) (d) Statutory and regulatory requirements (e) Requirements of supply which deviate from those previously expressed Project team leader is responsible to ensure any deviation from the initial order is resolved and communicated to the relevant personnel or division in the company. 8. This control is applied when: (a) Products and services from external providers are intended for incorporation into the DTE ’s products and services. reputation. Effectiveness of the controls applied by the external provider. based on their ability to provide products and services in accordance with our requirements and applicable standards. Follow-up action arises from this evaluation shall be recorded. release of products and services. monitoring of performance. (b) Define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output. Determine the verification. re-define its control to assure external providers conform to requirements. The company shall continuously control its externally provided products and services to ensure they do not adversely affect the XXXX’s ability to consistently deliver conforming products to the customers. Therefore. Relevant personnel shall clearly communicate to external providers its requirements for: (a) Products and services to be provided (b) Approval of: products and services.The company has determined and apply criteria for the evaluation. The company shall ensure the adequacy of requirements prior to their communication to the external provider. The company shall periodically review the effectiveness of the control that it applies to the external providers and where deemed necessary. The control applied shall be as adequate as is necessary to meet requirements for the products/services supplied. (c) Take into consideration: Potential impact of the externally provided processes. necessary to ensure that the externally provided products and services meet requirements. the company shall take into consideration policies of the organization and the expectation of the interested party. When determining the criteria for the evaluation. and re-evaluation of external providers. . selection. products and services on XXXX’s ability to consistently meet customer and applicable statutory and regulatory requirements. the company shall: (a) Ensure that externally provided processes remain within the control of its quality management system. processes and equipment. or other activities. methods. Evaluation criteria and the records of evaluation shall be maintained. including.5.5 PRODUCTION PROVISION 8. (g) Verification or validation activities that the company intends to perform at the external providers’ premises (if necessary). 14001. (e) The use of suitable equipment. (f) Control and monitoring of the external providers’ performance to be applied by the Company. (f) The availability and use of suitable monitoring and measuring devices. etc) (e) External providers’ interactions with the XXXX. Therefore. . including any required qualification of persons and relevant regulatory requirements (d) Certification of management system (e/g: ISO 9001. (c) Competence. as applicable: (a) Availability of contracts information that specifies the characteristics of the product (b) The establishing and maintaining documented procedures to cover situations where their absence could lead to deviations from the policy and the objectives and targets. 18001. (g) The implementation of suitable monitoring and measurement. as necessary. (d) The availability of work instructions / method statement. implemented and maintained procedures to identify. the personnel shall ensure the adequacy of specified requirements prior to their communication to the external provider. operational and service provision under controlled conditions. No Related Documentations 1 XXXX/SP10 Procurement Control 2 XXXX/SP11 Control of External Provider 8. plans and carries out production.1 CONTROL OF SERVICE PROVISION XXXX has established. (c) The availability of information that describes the characteristics of the product and stipulating operating criteria in the procedures. (h) The implementation of release. tags or stickers. XXXX has established. The operation and purchasing personnel are responsible to confirm the materials purchased and goods received are correct. documented. No Related Documentations 1 XXXX/SP08 Tender Process 2 XXXX/SP09 Project Management & Control 3 Quality Manual . (i) The method in the activities and materials are control correctly and minimize the risks/impacts. All materials shall be purchased and delivered by supplier with delivery order or invoice. it shall be controlled using a unique identification starting from raw materials to final product and delivered to the customer in accordance with the relevant procedures. in-process materials and finished goods are identified with relevant labels. delivery and post-delivery activities. 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 8.2 IDENTIFICATION AND TRACEABILITY The status of material and goods received. during all stages of operations and delivery to the customer. implemented and maintained a system for the identification and traceability of products and materials from receiving. which are traceable to the quality results and date of services provided.5. (j) Implementation of actions to prevent human error. When traceability is a statutory or contractual requirement. 5. Customer or external provider property provided for use or incorporation into the product or services will be suitably identified.5. or otherwise found to be unsuitable for use will be recorded and reported to the customer. damaged. There are additional preservation requirements to the goods during delivery to the customer. storage.5 POST DELIVERY ACTIVITIES The post-delivery activities can include actions under warranty provisions and contractual obligations. XXXX has determined the extent of post-delivery activities by considering below factors: (a) statutory and regulatory requirements. protected and safeguarded. The details about handling. (b) potential undesired consequences associated with its products and services. There is no material which is sensitive to the climate and stored directly under sunlight.5. Any customer or external provider property that is lost. .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.4 PRESERVATION The incoming materials and goods are stored at the designated area to avoid from wet or damaged. 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 8.8. Goods are stored in a covered warehouse. No Related Documentations 1 XXXX/SP09 Project Management & Control 2 XXXX/SP15 Customer Satisfaction 3 Quality Manual 8. verified. 5. (b) Traceability to the person(s) authorizing the release. No product can be released for delivery until the necessary action has been carried out. (c) customer specified requirements. The project team shall retain documented information on the release of products. Products that meet the criteria are released for delivery and the related records shall indicate the person authorizing the release of products.6 RELEASE OF PRODUCTS XXXX shall implement planned arrangements which include quality inspection and monitoring. The company shall retain records describing the results of the review of changes. to the extent necessary to ensure continuing conformity with requirements. The release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed. No Related Documentations 1 XXXX/SP08 Tender Process 2 XXXX/SP09 Project Management & Control 3 XXXX SP15 Customer Satisfaction 4 Quality Manual 8. No Related Documentations 1 XXXX/SP08 Tender Process 2 XXXX/SP09 Project Management & Control 3 Quality Manual 8. and any necessary actions arising from the review. to verify that the product requirements have been met. (d) customer feedback. the person(s) authorizing the change. The documented information shall include: (a) Testing report/ certificate which provide the evidence that product / service fulfils acceptance criteria. at appropriate stages throughout provision of production.6 CONTROL OF CHANGES The project team shall review and control changes for production or service provision. . Urgent release before completing the test is upon the approval from customer or Managing Director. following action shall be taken (wherever applicable): (a) Applying clear identification (b) Correction (e/g: rework/ re-blending). Project Team shall take appropriate action based on the nature of the nonconformity and its effect on the conformity of products. No Related Documentations 1 XXXX/SP09 Project Management & Control 2 Quality Manual 8. No Related Documentations 1 XXXX/SP09 Project Management & Control 2 XXXX/SP05 Continual Improvement 3 Quality Manual . (d) Informing the customer and/ or external provider. containment. return or suspension of provision of products. is identified and controlled to prevent unintended use or delivery. which does not conform to requirements. (c) Carry out proper segregation.7 CONTROL OF NONCONFORMING OUTPUTS XXXX has established. When nonconforming outputs are detected. implemented and maintained procedure to ensure that activities. Effective communication shall be in place to enable proper control on this nonconforming product by relevant party. (e) Obtaining authorization for acceptance under concession/ waiver (where applicable) Conformity to the requirements shall be verified when nonconforming outputs are corrected. product and services. No Related Documentations 1 XXXX/SP15 Customer Satisfaction 2 Complaint record 3 Customer NCR 9. The frequency of Customer Satisfaction Survey will be carried out at yearly or project basis. MEASUREMENT.1. PERFORMANCE EVALUATION 9. to ensure conformity of the product. 9.1 MONITORING AND MEASUREMENT OF PROCESSES. Incoming. . Any action taken is documented. and records shall be maintained at least 3 years to study the trend. The result of survey will be assessed.1. Test methods or visual inspection or check are carry out to the goods that are to be delivered to the customers. evaluated and reported during the management review. When planned results are not achieved. collect and analysed the information and data to evaluate the effectiveness of QMS by using appropriate Chart or any statistical means to provide input for continual improvement. The feedback or information from customers’ perception to the XXXX is through calls. reports.1 MONITORING. measurement of the QMS processes.9. PRODUCT AND SERVICE XXXX applies suitable methods for monitoring and. in-process and final inspection or checking are carried out accordingly based on specifications. complaints or results of customer Survey.1. as appropriate. correction and corrective actions will be taken. The criteria are defined based on the product quality delivery status. These methods shall demonstrate the ability of the processes to achieve planned results. where applicable.3 Analysis and Evaluation XXXX shall determine. ANALYSIS AND EVALUATION 9. communication and cost.2 Customer Satisfaction Information on customer satisfaction or dissatisfaction is obtained by the sales. This data is analysed to provide information relating to: (a) Customer satisfaction (b) Conformance to product requirements. adequately and effectively. and the reporting of verification result.3 MANAGEMENT REVIEW XXXX shall review the QMS at least once a year and at an interval of not more than 12 months to determine whether the QMS is continually managed suitably. Follow-up action shall commence include the verification of the implementation of corrective action. The audit objectives are to measure the system conformity against the ISO 9001:2015 standard as well as the XXXX ’s procedures shall be performed. quality policy and quality objectives. (c) Characteristics of trends of processes and products including opportunities for preventive action. It also will be used to assess the opportunities for improvement and changes required in the quality management system. . The internal audit shall be carried out at least once a year. No Related Documentations 1 XXXX /SP02 Internal Audit 9. The QMR shall plan the audit program taking into consideration the status and importance of the activities and areas to be audited as well as the results of previous audits. This includes data generated as a result of monitoring and measurement and from any other relevant sources. The audit scope shall cover all requirements by the standard and procedures developed.2 INTERNAL AUDIT The Quality Management Representative (QMR) shall arrange periodic internal audit to be conducted to determine whether the quality management system conforms to the requirements of the ISO 9001:2015 standard and has been effectively implemented and maintained. Management shall take timely corrective action on any deficiency found during the audit. The selection of auditors shall be the people other than whom they perform the activity being audited. (d) Suppliers performance (e) Result of evaluation of compliance to legal and other requirements (if necessary) 9. monitoring and measurement results. the extent to which Quality objectives have been met. customer satisfaction and feedback from relevant interested parties. nonconformities and corrective actions. (a) Policy and the extent to which objectives and targets have been met. (d) information on the performance and effectiveness of the Quality Management System. (c) Review on objectives and targets including progress of programme. (e) adequacy of resources. ii. audit results. iii.The Management Review Team (MRT) shall comprise of follows: (a) Managing Director (b) QMR (c) QMS committee (d) Head of Departments (e) Document controller (f) Other key personnel (where appropriate) 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. conclusions and recommendations for necessary action. iv. (b) changes in external and internal issues that are relevant to the Quality Management System including change on legal or process. v. (f) effectiveness of actions taken to address risks and opportunities (g) Recommendations for improvements Management Review shall focus on observations. including trends in: i. performance of external providers. vi. The possible need for changes to the QMS shall include. vii. (b) Results from internal and external audit . process performance and conformity of products and services. No Related Documentations 1 XXXX /SP03 Management Review 10. the QMR shall prepare an agenda and related information and circulate to all members before the meeting to ensure each person are ready if they need to present any data or information. The MRT shall address the possible need for changes. (c) Continuity suitability of the QMS in relation to changing conditions and information or (d) Concern amongst relevant interested parties. Before each meeting. Any plan changes shall be managed according to procedure Management of Change (MoC). These shall include: (a) Improving products quality or delivery to meet requirements as well as to address future needs and expectations. (b) Determine suitable strategies for achievement of services related to customer requirements and compliance to updated legal requirements. (c) Resource needs. (c) Improving the performance and effectiveness of the Quality management system . (b) Correcting. The review shall be recorded and kept for at least 3 years. IMPROVEMENT 10. (d) Monitoring achievement of the services and compliance. preventing or reducing undesired effects. decisions for improvement and actions related to: (a) Evaluating opportunities for improvement of the effectiveness of the IMS and its processes.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. The Document controller shall be responsible for maintaining records of Management Review. (f) Incidents statistics. The areas are. (d) Determining and implementing action needed. (g) Employees suggestion. (h) Internal and external feedback. (c) Internal and external audit results (d) Analysis of data (e) Corrective action. The procedure defines the requirements for: (a) Reviewing non-conformities (including client complaints).10. and (i) Management review No Related Documentations 1 XXXX/SP05 Continual Improvement . It shall be appropriate to the effects of the non-conformities encountered.- (a) Policy (b) QMS objectives. (c) Evaluating the need for action to ensure that non-conformities do not reoccur. 10. and Preventive action.3 CONTINUAL IMPROVEMENT The following areas are used to improve the effectiveness of QMS through monitoring and measurement data and review their achievements as stated below. (e) Records results of action taken. (f) Reviewing corrective action taken. (b) Determining the causes of non-conformities.2 NONCONFORMITY AND CORRECTIVE ACTION XXXX shall take action to eliminate the cause of non-conformities in order to prevent recurrence. 11. APPENDICES LIST APPENDIX 1 .Organization Chart APPENDIX II .Quality Policy APPENDIX IV .Quality Objectives APPENDIX V .QMS Processes Interaction APPENDIX 1 .Organization Chart .Mission & Vision APPENDIX III . . Oil & Gas. we can provide the energy to make it work and service provider for Oil & Gas. To provide excellent in working environment for all employees. Power Plant Construction. whenever and wherever you are planning it. petrochemical. Maintenance and Hook Up commissioning and marine works. XXXX will assist global customers all the way from the design stage through product and customer support up to providing global service network.APPENDIX II . Whatever your project. Misson To be the best source of total provider for xxxx works.Mission & Vision Vision The company’s long term vision is to be recognized as a worldwide complete systems and solution provider in Petrochemical. power plant construction and marine works. APPENDIX III . This policy implement in all areas of operations by: Maintaining a Quality Management System meet the requirements of ISO 9001.Quality Policy XXXX Xxxx Sdn Bhd recognizes Quality as an essential element that provides the Company with its continued success within the International xxxx industry. . Responding to client’s needs and expectations. Continually improving the effectiveness of our Quality Management System. Ensuring a clear understanding of our Client’s requirements. To earn business and loyalty from both our dealers and customers. codes and standards. Safety and Environment Standard Requirement. it is XXXX Xxxx Sdn Bhd policy to provide our Clients with products and services which fully meet their specified requirements and expectations and comply with relevant regulations. Consequently. COMPANY CORE VALUE : - To maintain Healthy. High Quality of work Team Work and Production Challenge Customer Satisfaction Risk Assessment and Management inputs Continuous Improvement. every time and on time. Approved by …………………………………. The Management of XXXX Xxxx Sdn Bhd is committed to active participation in the implementation and regular review of the Quality Management System and the establishment of a corporate climate.………………………………………… Managing Director XXXX XXXX SDN BHD DATE: 1st December 2016 APPENDIX IV . Our Quality Objectives are: • To attain more than 80% customer satisfaction • To ensure nonconformity report issued by client is not more than five (5) per project • To ensure TIMELY COMPLETION for every project • To ensure ZERO INCIDENT OR ACCIDENT at project site • To ensure at least 80% training plan completion . Enabling all our employees to meet quality requirements and striving to achieve good work first time. levels and processes within the organization.Quality Objectives Top Management of XXXX XXXX SDN BHD has established Quality Objectives at relevant functions. The objectives are consistent with the Quality policy including our commitment to enhance customer satisfaction. continual improvement and comply with applicable requirements. which encourage excellence through continuous improvement. specific quality objectives are established at relevant functions and all levels within XXXX organization.QMS Processes Interaction . Approved by ……………………………………………………………… Managing Director XXXX XXXX SDN BHD DATE: 1st December 2016 APPENDIX V . By mutual encouragement. all XXXX employees will perform their task diligently in contribution to the achievement of our quality objectives. commitment and cooperation through teamwork. These objectives will be regularly measured and reflected to ensure our strategic objective to maintain in high quality standard. • To ensure discrepancy between actual project cost and budget is not more than 5% Consistent with this policy.