QUALITY MANAGEMENT SYSTEM - OSH-ISIS

1 Back to QMS Structure QUALITY MANAGEMENT SYSTEM YEAR 2015 [You can add an abstract or other key statement here. An abstract is typically a short summary of the document content.] Full Name Company Sdn. Bhd. Kuala Terengganu, Terengganu, Malaysia Tel 03 - 78051140 Fax 03 - 78043811 Email TABLE OF CONTENTS Contents CHAPTER 1: QUALITY MANUAL QUALITY Manual _____ 1 Section1: Introduction _____1 About the Company _____1 Objective of this QUALITY Manual _____1 Section 2. Company Profile _____2 Section 3: Abbreviation _____2 Section 4: Description of QUALITY Manual _____2 QMS Document Structure _____4 Organizational Context _____4 4. Organizational Context of Full Name Company Sdn. Bhd. _____9 Understanding the context of the Short Name _____9 Understanding the needs and expectations of interested parties _____ 10 Scope of QUALITY MANAGEMENT SYSTEM _____ 10 QUALITY MANAGEMENT SYSTEM and determined processes_____ 11 5 Leadership and commitment _____ 13 General responsibilities _____ 13 QUALITY Policy _____ 14 Organizational Roles, Responsibility and Authorities _____ 14 6 MANAGEMENT of Risks and QUALITY Objectives _____ 16 Risk MANAGEMENT _____ 16 QUALITY Objective _____ 17 Planning of changes _____ 17 7 Support _____ 18 Resource _____ 18 Competence _____ 21 Awareness _____ 21 Communication _____ 22 TABLE OF CONTENTS Documented Information _____ 22 8.

2 Operation _____ 24 Project Planning _____ 24 Requirement for products and services_____ 25 Design and development of products and services _____ 27 Control of externally provided processes, products and services _____ 27 Provision of construction project MANAGEMENT _____ 27 Release of products and services _____ 30 Control of Nonconforming output _____ 31 9. Performance Evaluation _____ 32 Monitoring, measurement, analysis and evaluation _____ 32 Internal Audit_____ 34 MANAGEMENT Review _____ 34 10. Improvement _____ 36 General _____ 36 Nonconformity and corrective action _____ 36 Continual Improvement _____ 37 CHAPTER 2: PROCEDURE Documented Information Control Procedure _____ 38 General Requirement _____ 39 Common Definition used _____ 39 Responsibility and authority _____ 39 Documented Information Control Process _____ 39 New Creation of Document _____ 39 Amendment of Existing Document _____ 40 MANAGEMENT of Controlled Document _____ 40 MANAGEMENT of Controlled Records _____ 40 Internal Audit Procedure _____ 43 General Requirement _____ 44 TABLE OF CONTENTS Common Definition used _____ 44 Responsibility and authority _____ 44 Selection of Auditors _____ 44 Pre-Audit Activity _____ 44 During Audit Activity _____ 45 Post-Audit activities _____ 46 Purchasing Procedure _____ 47 General Requirement _____ 48 Common Definition used _____ 48 Responsibility and authority _____ 48 Expected output of purchasing process / outsourced process _____ 48

3 Purchasing process control _____ 48 Outsourced Process control _____ 49 External Provider Performance Monitoring _____ 49 Control of Non-Conformity Procedure _____ 51 General Requirement _____ 52 Common Definition used _____ 52 Responsibility and authority _____ 52 Identification of non-conformity _____ 52 Control of Nonconformity _____ 52 Corrective Action Procedure _____ 55 General Requirement _____ 56 Common Definition used _____ 56 Responsibility and authority _____ 56 Identification of non-conformity occurrence _____ 56 Corrective Action _____ 56 CHAPTER 3: APPENDICE Appendix _____ 58 Process Mapping & Interaction _____ 58 TABLE OF CONTENTS Business Process Mapping _____ 59 Project MANAGEMENT Process Sequence _____ 60 Documented Information Masterlist _____ 61 Risk and opportunities _____ 62 Risk Analysis Document _____ 63 MANAGEMENT SYSTEM Committee _____ 65 Organization _____ 65 Appendiks _____ 66 CHAPTER 4: STANDARD REQUIREMENT Standard Requirement of ISO9001:2015 _____ 67 1.

4 Scope _____ 68 2. Normative references _____ 69 3. Terms and definitions _____ 69 4. context of the organization _____ 69 Understanding the organization and its context _____ 69 Understanding the needs and expectations of interested parties _____ 70 Determining the scope of the QUALITY MANAGEMENT SYSTEM _____ 70 QUALITY MANAGEMENT SYSTEM and its processes _____ 71 5. Leadership _____ 71 Leadership and Commitment _____ 71 Policy _____ 72 Organizational Roles, Responsibility and Authorities _____ 73 6. Planning _____ 73 Action to address risks and opportunities _____ 73 QUALITY Objectives and planning to achieve them _____ 74 Planning of changes _____ 75 7. Support _____ 75 Resources _____ 75 Competence _____ 77 TABLE OF CONTENTS Awareness _____ 77 Communication _____ 78 Documented Information _____ 78 8. Operation _____ 79 Operational planning and control _____ 79 Requirement for products and services_____ 80 Design and development of products and services _____ 81 Control of externally provided processes, products and services _____ 83 Production and service Provision _____ 84 Release of products and services _____ 86 Control of nonconforming outputs _____ 86 9.

5 Performance Evaluation _____ 87 Monitoring, measurement, analysis and evaluation _____ 87 Internal Audit_____ 88 MANAGEMENT Review _____ 89 10. Improvement _____ 90 General _____ 90 Nonconformity and corrective action _____ 90 Continual Improvement _____ 91 CHAPTER 5: ANNEX & VOCABOLARY ANNEX A (Informative): Clarification of new structure, terminology and concepts _____ 91 Structure and terminology _____ 91 Products and services _____ 92 Understanding the needs and expectations of interested parties _____ 92 Risk Based Thinking _____ 93 Applicability _____ 93 Documented information _____ 94 Organizational knowledge _____ 94 Control of externally provided processes, products and services _____ 94 TABLE OF CONTENTS ISO 9000:2015 QUALITY MANAGEMENT systems Fundamentals and vocabulary _____ 95 QUALITY MANUAL Page 1 Full Name Company Sdn.

6 Bhd QUALITY Manual SECTION1: INTRODUCTION About the Company Full Name Company Sdn. Bhd. or to be known as Short Name adopts the ISO 9001:2015 QUALITY MANAGEMENT SYSTEM . Requirement as the principle for developing this QUALITY MANAGEMENT SYSTEM (QMS). The extent of this QMS established is based on the nature of our organization, complexity and interaction of the processes and competency of our personnel. The Top MANAGEMENT of Short Name shall demonstrate its full commitment in establishing, documenting, implementing, maintaining and continual improvement of this QMS in accordance with the ISO 9001:2015 requirements. To implement this QUALITY MANAGEMENT SYSTEM , Short Name has :- 1. Identified the processes needed for the QUALITY MANAGEMENT SYSTEM ; 2. Determined the sequence and interaction of these processes; 3. Determined criteria and methods required to ensure the effective operation and control of these processes; 4.

7 Ensured the availability of information necessary to support the operation and monitoring of these processes; 5. Measured, monitored and analyzed these processes, and implemented action necessary to achieve planned results and continual improvement. MISB shall be committed to control outsourced process to ensure such processes are carried out based on the contractual requirements. The extent of control shall be as followed: 1. Potential impact that the product is provided 2. Degree to which the control of the process is shared 3. Capability of achieving the control through clause Communication. Objectivee o ths uuaisty aanuai This QUALITY Manual specifies requirements for a QUALITY MANAGEMENT SYSTEM (QMS) to be applied to Full Name Company Sdn. Bhd. when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and QUALITY MANUAL Page 2 Full Name Company Sdn.

8 Bhd b) aims to enhance customer satisfaction through the effective application of the SYSTEM , including processes for improvement of the SYSTEM and the assurance of conformity to customer and applicable statutory and regulatory requirements. c) to be certified according to ISO 9001 All the requirements of this QUALITY Manual are intended to be applicable to Short Name. This manual is also provides the guideline to implement the process in systematic way and where necessary, the generation of procedures could be important as an explanatory statement for each unit of operation to run the process. If procedure is required to be outlined, it should be addressed in this manual remarked as reference. NOTE 1 In this QUALITY Manual, the terms product or service only apply to products and services offered to customer as addressed in section of the ISO9001 Standard.

9 NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. SECTION 2. COMPANY PROFILE A brief statement about organization and its activities SECTION 3: ABBREVIATION SECTION 4: DESCRIPTION OF QUALITY MANUAL QUALITY MANUAL Page 3 Full Name Company Sdn. Bhd DOCUMENT REF. NO.: QM-0 REVISION HISTORY NO. PINDAAN TARIKH KETERANGAN PINDAAN PEGAWAI 0 13-Sep-15 Versi awalan dilancarkan QUALITY MANUAL Page 4 Full Name Company Sdn. Bhd QMS DOCUMENT STRUCTURE Organszationai Context Organizational ContextUnderstanding the context of the the needs and expectations of interested of QUALITY MANAGEMENT MANAGEMENT SYSTEM and determined and CommitmentGeneral Roles, Responsibility and Manual ISO 9001 Requirement QUALITY MANUAL Page 5 Full Name Company Sdn.

10 Bhd MANAGEMENT of Risk & QUALITY ObjectivesRisk of Manual ISO 9001 Requirement Supports: ResourcesGeneral MANUAL Page 6 Full Name Company Sdn. Bhd Manual ISO 9001 Requirement Documented Information Control Procedure QUALITY MANUAL Page 7 Full Name Company Sdn. Bhd & provider Procedure QUALITY Manual ISO 9001 Requirement QUALITY MANUAL Page 8 Full Name Company Sdn. Bhd Operation: Process ControlProcess & of Manual ISO 9001 Requirement OperationProduct of of Non-Conformity Procedure QUALITY MANUAL Page 9 Full Name Company Sdn. Bhd 4. ORGANIZATIONAL CONTEXT OF FULL NAME COMPANY SDN. BHD. Under tandsng the context o the Short Name The MANAGEMENT of Short Name shall determine 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 .