ISO 9001:2015 Establish

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ISO 9001:2015 Establish by Mind Map: ISO 9001:2015 Establish

1. QMS Performance & RSV's QMS Pilot Processes

1.1. P1: MANAGER AND LEAD

1.1.1. 00_ Procedure for Document and Record Control (7.5)

1.1.1.1. 00. Procedure for Document and Record Control (7.5)

1.1.1.2. 001. Appendix 1 - List of Internal Documents

1.1.1.3. 002. Appendix 2 - List of External Documents

1.1.1.4. 003. Appendix 3 - List of Types of Records

1.1.1.5. 004. Appendix 4 - Registry of Records for Detention / Central Archive

1.1.2. 01. Project Plan

1.1.3. 02. Quality Policy

1.1.3.1. 02. Quality Policy (5.2)

1.1.3.2. 021.. Appendix 1- Quality Objectives (6.2)

1.1.4. 03. Quality Manual

1.1.5. 04. Procedure for determining Context of the Organization and Interested Parties

1.1.5.1. 040- Procedure for determining Context of the Organization and Interested Parties (4.1; 4.2)

1.1.5.2. 041. Appendix 1- List of Interested Parties (4.2)

1.1.5.3. 042. Appendix 2 - Conformance Evaluation Record (4.2)

1.1.5.4. 043. Appendix 3 - Scope of the Quality Management System (4.3)

1.1.6. 18. Procedure for Internal Audit

1.1.6.1. 180 - Procedure for Internal Audit - (9.2)

1.1.6.2. 181 - Appendix - Internal Audit Checklist

1.1.6.3. 182 - Internal Audit Program (9.2.2)

1.1.6.4. 183 - Internal Audit Report (9.2.2)

1.1.6.5. 184 - Internal Audit Plan -(M-8.2.4)

1.1.7. 21. Procedure for Management Review

1.1.7.1. 210 - Procedure for Management review (9.3)

1.1.7.2. 211 - Appendix 1 - Matrix of Key Performance Indicators (9.1.3)

1.1.7.3. 212 - Appendix 2 - Data Analysis Report (9.1.3)

1.1.7.4. 213 - Appendix 3 - Management Review Minutes (9.3.3)

1.1.8. 06. Procedure for Risks Management - (6.1)

1.1.8.1. 060 - Procedure for Addressing Risks and Opportunities (6.1)

1.1.8.2. 061 - Appendix 1 - Registry of Key Risks and Opportunities (6.1)

1.1.8.3. 062 - Appendix 2 - Procedure for FMEA Risk Assessment (6.1)

1.1.8.4. 063 - FMEA Risks Assessment Record (6.1)

1.1.9. Pilot Characteristics

1.2. P10: HUMAN RESOURCES AND ADMINISTRATION

1.2.1. 04. Procedure for Human Resource

1.2.1.1. 040 - Procedure for Competence Training and Awareness (7.1.2; 7.2; 7.3)

1.2.1.2. 041 - Appendix 1 - Training Program (7.2)

1.2.1.3. 042 - Appendix 2 - Training Record (7.2)

1.2.1.4. 043 - Appendix 3 - Record of Attendance (7.3)

1.3. P6: PROSPECT DEVELOPMENT ASSIST CUSTOMERS (SALE)

1.3.1. 07. Sale procedure

1.3.1.1. 070 - Sale Procedure (8.2)

1.3.1.2. 071 - Appendix 1 - Customer requirement Review Checklist (8.2.2; 8.2.3)

1.3.1.3. 072 - Appendix 2 - Registry of Customer Complaints (8.2)

1.3.1.4. 119.1 - Procedure for wholesale and Retail Operations (8.2)

1.3.2. 08. Procedure for Customer Communication Feedback and Complaints

1.3.3. 15. Procedure of Measuring Customer Satisfaction

1.3.3.1. 150 - Procedure for Measuring Customer satisfaction (9.1.2)

1.3.3.2. 151 - Appendix - Customer Satisfaction Questionnaire (9.1.2)

1.3.3.3. 152 - Report of Customer Satisfaction (9.1.2)

1.3.3.4. 153 - Monitoring of Customer Satisfaction (9.1.2)

1.4. P3: FORMULA AND RESEARCH

1.4.1. 06. Procedure for Risks Management -

1.4.1.1. 060 - Procedure for Addressing Risks and Opportunities (6.1)

1.4.1.2. 061 - Appendix 1 - Registry of Key Risks and Opportunities (6.1)

1.4.1.3. 062 - Appendix 2 - Procedure for FMEA Risk Assessment (6.1)

1.4.1.4. 063 - FMEA Risks Assessment Record (6.1)

1.4.2. 09. Procedure for Design and Development

1.4.2.1. 090 - Procedure for Design and Development (8.3)

1.4.2.2. 091 - Appendix 1 - Project Task - Design and Development File (8.3.2; 8.3.3)

1.4.2.3. 092 - Appendix 2 - Project Plan and review (8.3.2; 8.3.4)

1.4.2.4. 093 - Appendix 3 - Change Review Record (8.3.6)

1.4.2.5. 094 - Appendix 4 - Design Review Minutes (8.3.5)

1.4.2.6. 095 - Appendix 5 - Design and Development Verification and Validation Plans - (M-7.3.6; 7.3.5)

1.4.2.7. 096 - Appendix 6 - Verification Report - (M-7.3.6)

1.4.2.8. 097 - Appendix 7 - Validation Report - (M-7.3.7)

1.4.2.9. 098 - Appendix 8 - Design and Development Transfer Record - (M-7.3.8)

1.5. P2: PURCHASE AND SUPPLY CHAIN

1.5.1. 10. Procedure for Purchase and Evaluation of Suppliers

1.5.1.1. 100 - Procedure for Purchasing and Evaluation of Suppliers (8.4)

1.5.1.2. 101 - Appendix 1 - Checklist for Evaluation of Suppliers (8.4)

1.5.1.3. 102 - Appendix 2 - List of approved Suppliers (8.4.1)

1.5.1.4. 103 - Appendix 3 - Registry of Complaints about Suppliers (8.4)

1.5.1.5. 104 - Appendix 4 - Request and Order for Purchasing (8.4.1)

1.5.1.6. 105 - Purchasing Verification Record - (M-7.4.3)

1.6. P4: PRODUCTION

1.6.1. 05. Procedure for Infrastructure and Work Environment

1.6.1.1. 050 - Procedure for Infrastructure and Work Environment - (M-6.3; 6.4.1; 6.4.2)

1.6.1.2. 051 - Appendix 1 - Record of Infrastructure and Work Environment - (M-6.3)

1.6.2. 11. Procedure for Production and Services Provision

1.6.2.1. 110 - Procedure for Production and Service Provision (8.5)

1.6.2.2. 111 - Appendix 1 - Product Specification (8.5.1)

1.6.2.3. 112 - Appendix 2 - Record of Product/ Service Conformance (8.5.1)

1.6.2.4. 113 - Appendix 3 - Quality Plan (8.5.1)

1.6.2.5. 114 - Appendix 4 - Notification to a Customer about changes on their Property (8.5.3)

1.6.2.6. 115 - Appendix 5 - Record of Traceability (8.5.2; 8.6)

1.6.2.7. 116 - Appendix 6 - Record of Production Process Validation - (M-7.5.6)

1.6.2.8. 117 - Appendix 7 - Production / Service Change Review Record (8.5.6)

1.6.2.9. 118 - Appendix 8 - Production Plan (8.1)

1.6.2.10. 119 - Appendix 9 - Production Registry (8.5)

1.6.2.11. 110 .1 - Appendix 10 - Procedure for Manufacturing (8.5)

1.6.2.12. 110.2 - Appendix 11 - Procedure for Production of Rubber and Plastic (8.5)

1.6.2.13. 110.3 - Appendix 12 - Record of Medical Device Installation - (M-7.5.3)

1.6.2.14. 110.4 - Appendix 13 - Record of Servicing Activities - (M-7.5.4)

1.7. P5: CONTROLS

1.7.1. 17. Procedure for Equipment Maintenance and Measuring Equipment

1.7.1.1. 170 - Procedure for Equipment Maintenance and Measuring Equipment (7.1.5)

1.7.1.2. 171 - Appendix 1- List of Equipments (7.1.5)

1.7.1.3. 172 - Appendix 2 - Plan for preventive Maintenance of Equipment (7.1.5)

1.7.1.4. 173 - Appendix 3 - Maintenance and Calibration Record (7.1.5.2)

1.7.2. 15. Procedure for Control of Nonconforming Producst

1.7.2.1. 150 - Procedure for Management of Non-conformities and Corrective actions - (8.7; 10.2)

1.7.2.2. 151- Appendix 1 - Non-conformity Record (8.7; 10.2.2)

1.7.2.3. 152- Appendix 2 - Corrective Action Record (10.2.2)

1.7.2.4. 153 - Appendix 3 - Registry and status of Non-conformity and Corrective Actions (10.2.2)

1.7.2.5. 154 - Appendix 4 - Registry of recalled/ Withdrawn Products - (M- 8.3.3)

1.7.3. 16. Procedure for Adverse Event Investigation and report

1.7.3.1. 160 - Procedure for Adverse Event Investigation and report -(M-8.2.3)

1.7.3.2. 161 - Appendix 1 - Investigate Report (M-8.2.3)

1.7.4. 19. Procedure for Corrective and Preventive Actions

1.7.4.1. 190 - Procedure for Corrective Actions and Preventive Actions - (M-8.5.2; 8.5.3)

1.7.4.2. 191 - Appendix 1 - Corrective / Preventive Action request (M-8.5.2; 8.5.3)

1.7.4.3. 192 - Registry and Status of Corrective actions and Preventive Actions (M-8.5.2; 8.5.3)

1.7.5. 20. Procedure for Data Analysis

1.7.5.1. 200 - Procedure for Data Analysis (M-8.4)

1.7.5.2. 201 - Appendix - Data Analysis Report (M-8.4)

1.7.6. 113 - Appendix 3 - Quality Plan (8.5.1)

1.8. P7: WAREHOUSING AND LOGISTICS

1.8.1. 14. Procedure for Warehousing & Logistics

1.8.1.1. 140 - Warehouse Procedure (8.5.4)

1.8.1.2. 141- Appendix - Record of Warehousing Temperature Control - (M-7.5.11)

1.9. P8: PROFILE ACTIVITY

1.9.1. 05. Procedure for Infrastructure and Work Environment

1.9.1.1. 050 - Procedure for Infrastructure and Work Environment - (M-6.3; 6.4.1; 6.4.2)

1.9.1.2. 051 - Appendix 1 - Record of Infrastructure and Work Environment - (M-6.3)

1.9.2. 11. Procedure for Production and Services Provision

1.9.2.1. 110 - Procedure for Production and Service Provision (8.5)

1.9.2.2. 111 - Appendix 1 - Product Specification (8.5.1)

1.9.2.3. 112 - Appendix 2 - Record of Product/ Service Conformance (8.5.1)

1.9.2.4. 113 - Appendix 3 - Quality Plan (8.5.1)

1.9.2.5. 114 - Appendix 4 - Notification to a Customer about changes on their Property (8.5.3)

1.9.2.6. 115 - Appendix 5 - Record of Traceability (8.5.2; 8.6)

1.9.2.7. 116 - Appendix 6 - Record of Production Process Validation - (M-7.5.6)

1.9.2.8. 117 - Appendix 7 - Production / Service Change Review Record (8.5.6)

1.9.2.9. 118 - Appendix 8 - Production Plan (8.1)

1.9.2.10. 119 - Appendix 9 - Production Registry (8.5)

1.9.2.11. 110 .1 - Appendix 10 - Procedure for Manufacturing (8.5)

1.9.2.12. 110.2 - Appendix 11 - Procedure for Production of Rubber and Plastic (8.5)

1.9.2.13. 110.3 - Appendix 12 - Record of Medical Device Installation - (M-7.5.3)

1.9.2.14. 110.4 - Appendix 13 - Record of Servicing Activities - (M-7.5.4)

1.10. P9: FINANCE

1.10.1. 22. Procedure for Finance

1.11. P11: HSE

1.11.1. 23. Procedure for HSE

1.11.2. 24. HSE Policy

1.12. P12: MAINTENANCE

1.12.1. Procedure for Equipment Maintenance and Predict Maintenance

1.12.1.1. 120 - Procedure for Equipment Maintenance and Predict Maintenance ( 7.1.3)

1.12.1.2. 121- Appendix 1 - List of Equipment and Machines

1.12.1.3. 122 - Plan for Preventive maintenance Equipments

1.12.1.4. 123 - Appendix 3 - Maintenance Equipment/ Machine Record

1.13. P13: IT

1.13.1. 13. Procedure for Software Validation

1.13.1.1. 130 - Procedure for Documentation and Validate of Computer Software - (M-4.1.6; 7.5.6)

1.13.1.2. 131 - Appendix 1 - Record of Software Validation (M-7.5.6)

2. Company (Organization)

2.1. 4. Organization & Its context

2.1.1. 4.1 Determine the external & Internal Issues that relevant to its purpose & strategic direction

2.1.1.1. Analysis the external & Internal Issues include Positive & negative factors or condition for consideration

2.1.1.1.1. External: Understanding the external context can be facilitated by considering issues arising from Legal, Technology, competitive, market, culture. social, economic environments whether international, national, regional or local

2.1.1.1.2. Internal: Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of organization

2.1.2. 4.1 Monitor & review information about external & Internal Issues

2.1.3. 4.3 The QMS Scope (Mandatory)

2.1.3.1. 4.1 External & Internal Issues

2.1.3.2. 4.2 The requirements of relevant interested parties

2.1.3.3. 4.3.c) Include all Products & Services

2.1.4. 4.4 QMS & Its Processes

2.1.4.1. 4.4.1 Shall Establish, Implement, Maintain & Continually improve a QMS, including the processes need and their interactions

2.1.4.1.1. a) Determine the input required & Outputs expected from these processes

2.1.4.1.2. b) Determine the sequence & interaction of these processes

2.1.4.1.3. c) Determine and apply the criteria and methods (Including monitoring, measurements and related performance indicators) need to ensure the effective operation and control of these processes

2.1.4.1.4. d) determine the resource needed for these processes & ensure their availability

2.1.4.1.5. e) Assign the responsibilities & authorities for these processes

2.1.4.1.6. f) Address the risks and opportunities as determined in accordance with the requirements

2.1.4.2. 4.4.2Extent necessary

2.1.4.2.1. a) Maintain documented information to support the operation of its processes

2.1.4.2.2. b) Retain documented information to have confidence that the processes are being carried out as planned

2.2. 5. Leadership

2.2.1. 5.1 Leadship & Commitment

2.2.1.1. 5.1.1 Demonstrate leadership & commitment with respect to QMS

2.2.1.2. 5.1.2 Customer focus

2.2.2. 5.2 Quality Policy (Mandatory)

2.2.2.1. 5.2.1 Establishing the quality policy

2.2.2.1.1. Top management shall establish, implement and maintain a quality policy that:

2.2.2.1.2. a) Is appropriate to the purpose and context of organization & support its strategy direction

2.2.2.1.3. b) Provides a framework for setting quality objectives

2.2.2.1.4. c) includes a commitment to satisfy applicable requirements

2.2.2.1.5. d) Include a commitment to continual improvement of the quality management system

2.2.2.2. 5.2.2 Communicating the quality policy

2.2.2.2.1. The quality policy shall:

2.2.2.2.2. a) Be available and be maintained as documented information

2.2.2.2.3. b) Be communicated, understood and applied within the organization

2.2.2.2.4. c) Be available to relevant interested parties, as approciate

2.2.3. 5.3 Organization roles, Responsibilities & Authorities

2.2.3.1. Top management shall ensure that the responsibilities and authorities to relevant roles as assigned, communicated and understood within the organization; the assign responsibility and authority for:

2.2.3.2. a) Ensure the QMS conforms to the requirements of ISO 9001:2015

2.2.3.3. b) Ensure that the processes are delivering their intended outputs

2.2.3.4. c) Report on the performance of the QMS and on opportunities for improvement (10.1), in particular to top management

2.2.3.5. d) Ensuring the promotion of customer focus throughout the organization

2.2.3.6. e) Ensure the integrity of QMS is maintained when change the QMS are planned and implemented

2.3. 6. Planning

2.3.1. 6.1 Actions to address risks & opportunities

2.3.1.1. 6.1.1 When planning for QMS, The Organization shall consider the Issues refferance to in 4.1 & 4.2 and determine the risks and opportunities that need to be addressed to:

2.3.1.1.1. a) give assurance that the risk QMS can achieve its intended result

2.3.1.1.2. b) enhance desirable effects

2.3.1.1.3. c) prevent or reduce undesired effects

2.3.1.1.4. d) achieve improvement

2.3.1.2. 6.1.2 The Organization shall plan

2.3.1.2.1. a) Actions to address these risks and opportunities

2.3.1.2.2. b) How to

2.3.2. 6.2 Quality Objectives & Planning to achieve them

2.3.2.1. 6.2.1 The Organization shall establish Quality Objectives at relevant fuctions, Levels and processes needed for QMS. The QO shall:

2.3.2.1.1. 1. Quality Objectives for QMS

2.3.2.1.2. 2. Quality Objectives for Functions, Departments

2.3.2.1.3. 3. Quality Objectives for Emloyees

2.3.2.2. a) Be consistent with the Quality Policy

2.3.2.3. b) Be measurable

2.3.2.4. c) Take into account applicable requirements

2.3.2.5. d) Be relevant to conformity of products and services and to enhancement of customer satisfation

2.3.2.6. e) Be Monitored

2.3.2.7. f) Be communicated

2.3.2.8. g) Be updated as appropriate

2.3.3. 6.3 Planning of Changes

2.3.3.1. When the organization determines the need for changes to QMS, The change shall be carried out in a planned manner (4.4)

2.3.3.2. a) The purpose of the changes and their potential consequences

2.3.3.3. b) The integrity of the QMS

2.3.3.4. c) The availability of resources

2.3.3.5. d) the allocation or reallocation of responsibilities and authorities

2.4. 7. Support

2.4.1. 7.1 Resource

2.4.1.1. 7.1.1 General:

2.4.1.1.1. The Organization shall determine and provide the resources need for the establishment, implementation, maintenance & Continual improvement QMS, that shall consider:

2.4.1.2. 7.1.2 People:

2.4.1.2.1. The Org shall determine and provide the persons necessary for the effective implementation of its QMS and for the operation & control of its processes

2.4.1.3. 7.1.3 Infrastructure:

2.4.1.3.1. The Org shall determine, provide and maintain the infrastructure necessary for the operation of it processes to achieve conformity of products & services, Infrastructure include:

2.4.1.4. 7.1.4 Environment for the operation of processes:

2.4.1.4.1. The org shall determine, provide and maintain the environment necessary for the operation of it processes to achieve conformity of products & services, The suitable environment can be combination of human & physical factors.

2.4.1.5. 7.1.5 Monitoring & Measuring resources

2.4.1.5.1. 7.1.5.1 General

2.4.1.5.2. 7.1.5.2 Measurement traceability

2.4.1.6. 7.1.6 Organization Knowledge

2.4.1.6.1. The Org shall determine the knowledge necessary for operation of its processes & to achieve conformity of products and services. This knowledge shall maintain and be made available to the extend necessary

2.4.2. 7.2 Competence

2.4.2.1. Organization shall:

2.4.2.1.1. a) Determine the necessary competence of persons doing work under its control that affects the performance & Effectiveness of QMS

2.4.2.1.2. b) Ensure that these persons are competent on the basic of appropriate education, training, or experience

2.4.2.1.3. c) Take the actions to acquire the necessary competence, evaluate the effectiveness of action taken

2.4.2.1.4. d) Retain appropriate documented information as evidences of competence

2.4.3. 7.3 Awareness

2.4.3.1. The Organization shall ensure persons understand:

2.4.3.1.1. a) The Quality Policy

2.4.3.1.2. b) Relevant Quality Objectives

2.4.3.1.3. c) Their contribution to effectiveness of QMS include the benefits of Improved performance

2.4.3.1.4. d) the implications of not conforming with the QMS requirements

2.4.3.1.5. Records of Training and Evaluate certificate after training

2.4.4. 7.4 Communication

2.4.4.1. Determine the Internal & External communications relevant to the QMS, including:

2.4.4.1.1. a) On what it will communicate

2.4.4.1.2. b) When to communicate

2.4.4.1.3. c) With whom to communicate

2.4.4.1.4. d) How to communicate

2.4.4.1.5. e) Who communicates

2.4.4.1.6. The assignment - delegate the QMR to communicate with Internal & external QMS

2.4.5. 7.5 Documented Information

2.4.5.1. Procedure (Flow chart) for control of documents & Records

2.4.5.1.1. Documents & Record Control Form

2.4.5.2. 7.5.1 General

2.4.5.2.1. The organization's QMS shall including:

2.4.5.3. 7.5.2 Creating & Updating

2.4.5.3.1. When Creating and/or Updating documented information, the company shall:

2.4.5.4. 7.5.3 Control of Documented Information

2.4.5.4.1. Record for Documents Control

2.4.5.4.2. 7.5.3.1 Documented information required by the QMS and by ISO 9001:2015 shall be controled to ensure:

2.4.5.4.3. 7.5.3.2 For control documented information, the Company shall adress the following activities:

2.5. 8. Operation

2.5.1. 8.1 Operation Planning & Control

2.5.1.1. The Organization shall plan, implement and control the processes (4.4) need to meet the requirements for the provision of products & Services, and to implement the actions determined (6) by:

2.5.1.1.1. a) Determining the requirements for the products and services

2.5.1.1.2. b) Establish criteria for:

2.5.1.1.3. c) Determining the resource needed to achieve conformity to product and service requirements

2.5.1.1.4. d) Implementing control of processes in accordance with criteria

2.5.1.1.5. e) Determining, maintaining and retaining documented information to the extent necessary

2.5.1.1.6. The Output of this Planning shall be suitable for the organization's operations

2.5.1.1.7. The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

2.5.1.1.8. The Organization shall ensure that outsourced processes are controlled. (8.4)

2.5.2. 8.2 Requirements for Products & Services

2.5.2.1. Sale Procedure

2.5.2.2. 8.2.1 Customer communication

2.5.2.2.1. Communicate with customers shall include:

2.5.2.3. 8.2.2 Determining the requirements for products and services

2.5.2.3.1. When determine the requirements for the products and services to be offered to customers, the organization shall ensure that:

2.5.2.4. 8.2.3 Review of the requirements for products and services

2.5.2.4.1. 8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products & Services to be offer to customers. The Organization shall conduct a review before committing to supply products and services to a customer, to include:

2.5.2.4.2. 8.2.3.2 The Organization shall retain documented information, as applicable:

2.5.2.5. 8.2.4 Change to requirements for products & Services

2.5.2.5.1. The Organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed

2.5.3. 8.3 Design & Development of Products and Services

2.5.3.1. Procedure for design and Development (R&D) (8.3)

2.5.3.2. 8.3.1 General

2.5.3.2.1. The Organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services

2.5.3.3. 8.3.2 Design and Development planning

2.5.3.3.1. Procedure/ Work Instruction for Design Review

2.5.3.3.2. Design & Development Review Record Form / Planning form

2.5.3.3.3. In determine the stages and controls for design and development, the Org shall consider:

2.5.3.3.4. a) The nature, duration and complexity of the design and development activities

2.5.3.3.5. b) the required processes stages, including applicable design and development review

2.5.3.3.6. c) the required design and development verification and validation activities

2.5.3.3.7. d) The responsibilities and authorities involved in the design and development process

2.5.3.3.8. e) The internal & External resource needs for the design and development of products and services

2.5.3.3.9. f) The need to control interfaces between persons involved in the design and development process

2.5.3.3.10. g) The need for involvement of customers and user in the design and development process

2.5.3.3.11. h) the requirements for subsequent provision of products & Services

2.5.3.3.12. i) The level of control expected for the design and development process by customers and other relevant interested parties

2.5.3.3.13. j) The documented information needed to demonstrate that design and developemt requirements have been meet

2.5.3.4. 8.3.3 Design and Development inputs

2.5.3.4.1. Record of Design and Development Inputs (8.3.3)

2.5.3.4.2. The Organization shall determine the requirements essential for the specific types of products and services to be designed and developed. the Org shall consider:

2.5.3.4.3. a) Functions & performance requirements

2.5.3.4.4. b) Information derived from previous similar design and development activities

2.5.3.4.5. c) Statutory and regulatory requirements

2.5.3.4.6. d) Standards & codes of practice that the organization had committed to implement

2.5.3.4.7. e) The potential consequences of failure due to the nature of products and services

2.5.3.4.8. Input shall be adequate for design and development purposes, complete and unambiguous. Conflicting design and development inputs shall be resolved

2.5.3.4.9. Organization shall retain documented information on design and development inputs

2.5.3.5. 8.3.4 Design and Development controls

2.5.3.5.1. Record of Design & Development Control (8.3.4)

2.5.3.5.2. The Organization shall apply controls to design and development process to ensure that:

2.5.3.5.3. a) The result to be achieved are defined

2.5.3.5.4. b) Reviews are conducted to evaluate the ability of results of design and development to meet requirements

2.5.3.5.5. c) Verification activities are conducted to ensure that the design and development outputs meet the input requirements

2.5.3.5.6. d) Validate activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use

2.5.3.5.7. e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities

2.5.3.5.8. f) Documented information of these activities is retained

2.5.3.5.9. Note: Design and development reviews, verification and validation have distinct purposes. they can be conducted separated or in any combination, as is suitable for the products and services of the organization.

2.5.3.6. 8.3.5 Design and Development Outputs

2.5.3.6.1. Record of Design and Development Outputs (8.3.5)

2.5.3.6.2. The Organization shall ensure that design and development outputs

2.5.3.6.3. a) Meet the input requirements

2.5.3.6.4. b) are adequate for the subsequent processes for the provision of products and services

2.5.3.6.5. c) Include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria

2.5.3.6.6. d) Specific the characteristic of the products and services that are essential for their intended purpose and their safe and proper provision

2.5.3.6.7. The org shall retain documented information on design and development outputs

2.5.3.7. 8.3.6 Design and Development Changes

2.5.3.7.1. Record of Design and Development Changes

2.5.3.7.2. The organization shall identify, Review and control changes made during, or subsequent to, the design and development of products and services, to extent necessary to ensure that there is no adverse impact on conformity to requirements

2.5.3.7.3. a) Design and development changes

2.5.3.7.4. b) The results of reviews

2.5.3.7.5. c) The authorization of the changes

2.5.3.7.6. d) The actions taken to prevent adverse impacts

2.5.4. 8.4 Control of External provided processes, products & Services

2.5.4.1. 8.4.1 General

2.5.4.1.1. Supplier Evaluation Record

2.5.4.1.2. The Organization shall ensure that externally provided processes, products and services conform to requirements

2.5.4.1.3. The Org shall determine the controls to be applied to externally provider processes, products & Services when:

2.5.4.1.4. The Organization shall determine and apply criteria for the evaluation, selection, monitoring of performance and re-evaluate of external providers, base on their ability to provide processes pr products and services in accordance with requirements. The Org shall retain documented information of these activities and any necessary actions araising from the evaluation.

2.5.4.2. 8.4.2 Type and extent of control

2.5.4.2.1. The Organization shall ensure that external provider processes, products and services do not adversely affect the organization's ability to consistently to deliver conforming products and services to its customers. The Organization shall:

2.5.4.3. 8.4.3 Information for external providers

2.5.4.3.1. The Organization shall ensure the adequacy of requirements prior to their communication to the external provider. The organization shall communicate to external providers it requirements for:

2.5.5. 8.5 Production & Service provision

2.5.5.1. 8.5.1 Control of Production and service provision

2.5.5.1.1. The Org shall implement production and service provision under controlled conditions. Controlled conditions shall include:

2.5.5.2. 8.5.2 Identification and Tracebility

2.5.5.2.1. The Identify and traceability procedure/flowchart

2.5.5.2.2. The Organization shall use suitable means to identify outputs when it necessary to ensure the conformity of products and results

2.5.5.2.3. The org shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision

2.5.5.2.4. The Org shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability

2.5.5.3. 8.5.3 Property belonging to customers or External providers

2.5.5.3.1. Record of changes on customer's or external provider's property

2.5.5.3.2. The Org shall excercise care with property belonging to customers or external providers while it is under the Org's control or being used by the Org

2.5.5.3.3. The org shall identify, verify, protect and safeguard customer's or external provider's property provided for use or incorporation into the products and services

2.5.5.3.4. When the property of a customer or external provider is lost, damaged, or otherwise found to be unsuitable for use, The Org shall report this to customer or external provider, and retain documented on what has occurred.

2.5.5.3.5. Note: A customer's or external provider's property can include materials, components, Tools and equipments, premises, intellectual property and personal data.

2.5.5.4. 8.5.4 Preservaton

2.5.5.4.1. The Org shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements.

2.5.5.4.2. Note: Preservation can include identification, handling, contamination control, Packaging, Storage, Transmission or transportation and protection

2.5.5.5. 8.5.5 Post-delivery activities

2.5.5.5.1. The Org shall meet requirements for Post-delivery activities associated with the products and services. In determining the extent of post-delivery activities that are required, the organization shall consider:

2.5.5.5.2. Note: Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal

2.5.5.6. 8.5.6 Control of Changes

2.5.5.6.1. Record for Review of Changes result

2.5.5.6.2. The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirement

2.5.5.6.3. The Org shall retain documented information describing the results of the review of changes, the person(s) authorizing the change and any necessary actions arising from the review.

2.5.6. 8.6 Release of Products & Services

2.5.6.1. The Org shall implement planned arrangements, at appropriate, to verify that the product and service requirements have been met.

2.5.6.2. The release of products and servicess to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevan authority and, as applicable, by the customers

2.5.6.3. The Organization shall retain documented information on the release of products and services include:

2.5.6.3.1. The COA or TDS, TPS

2.5.6.3.2. a) evidence of conformity with the acceptance criteria

2.5.6.3.3. Record -Traceability form to the person(S) Who accepted to release

2.5.6.3.4. b) Traceability to the person(s) authorizing the release

2.5.7. 8.7 Control of nonconforming outouts

2.5.7.1. Record of Nonconformity - 8D Form

2.5.7.2. 8.7.1 The Organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent the unintended use or delivery

2.5.7.2.1. The Organization shall take appropriate action based on the nature of the nonconformity of products and services. This shall also applied to nonconformity product & services detected after delivery of products during or after the provision of services

2.5.7.2.2. The Organization shall deal with nonconforming outputs in one or more of the following ways:

2.5.7.2.3. Conformity to the requirements shall be verified when nonconforming outputs are corrected.

2.5.7.3. 8.7.2 The organization shall retain documented information that:

2.5.7.3.1. a) Describes the nonconformity

2.5.7.3.2. b) Describes the actions taken

2.5.7.3.3. c) Describes any concessions obtained

2.5.7.3.4. d) Identified the authority deciding the actions in respect of nonconformity.

2.6. 9. Performance Evaluate

2.6.1. 9.1 Monitoring, Measurement, analysis and evaluate

2.6.1.1. 9.1.1 General

2.6.1.1.1. Record of QMS performance Evaluation

2.6.1.1.2. The Organization shall Determine:

2.6.1.1.3. The Organization shall evaluate the performance and the effectiveness of the QMS. The Organization shall retain appropriate documented information as evidence of the result

2.6.1.2. 9.1.2 Customer Satisfation

2.6.1.2.1. The Organization shall monitor customer's perception of the degree to which their needs and expectations have been fullilled. The Organization shall determine the methods for obtaining, monitoring and review this information

2.6.1.2.2. Note: Examples of monitoring customer perception can include customer's surveys, customer feedback on delivered products & Services, meeting with customer, Market-share analysis, compliment, warranty claims and dealer report

2.6.1.3. 9.1.3 Analysis and Evaluation

2.6.1.3.1. The organization shall analyse and evaluate appropriate data and information arising from monitoring and measurement. The result of analysis shall be used to evaluate:

2.6.1.3.2. Note: Method to analysis data can include statistical techniques

2.6.2. 9.2 Internal Audit

2.6.2.1. 9.2.1 The organization shall conduct internal audits at planned intervals to provide information on whether the QMS

2.6.2.1.1. a) Conform to:

2.6.2.1.2. b) Is effectively implemented and maintained

2.6.2.2. 9.2.2 The Organization shall:

2.6.2.2.1. a) Plan, Establish, implement and maintain an audit programme (s) including the frequency, methods, responsibilities, planning, requirements and reporting which should take into consideration the importance of the processes concerned, changes affecting the organization and result of previous audits

2.6.2.2.2. b) Define the audit criteria and scope for each audit

2.6.2.2.3. c) Select auditors and conduct audits to ensure objectivity and impartially of the audit process.

2.6.2.2.4. d) ensure that the results of the audits are reported to relevant management

2.6.2.2.5. f) Retain documented information as evidence of the implementation of the audit programme and audit results

2.6.2.3. Note: See ISO 19011 for guidance

2.6.3. 9.3 Management Review

2.6.3.1. 9.3.1 General

2.6.3.1.1. Top management shall review the organization's QMS, at Planned interval to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization

2.6.3.2. 9.3.2 Management review inputs

2.6.3.2.1. The Management review shall be planned and carried out taking into consideration:

2.6.3.3. 9.3.3 Management Review Outputs

2.6.3.3.1. The outputs of the management review shall include decisions and actions related to:

2.6.3.3.2. The Organization shall retain documented information as evidence of the results of management reviews.

2.7. 10. Improvement

2.7.1. 10.1 General

2.7.1.1. The Organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction, these shall include:

2.7.1.1.1. a) improving products and services to meet requirements as well as to address future need and expectations

2.7.1.1.2. b) Correcting, Preventing or reducing undesired effect

2.7.1.1.3. c) Improving the performance and effectiveness of the QMS

2.7.1.2. Note: The Improve can include correction, Corrective actions, continual improvement, breakthrough change, innovation and re-organization

2.7.2. 10.2 Nonconformity and Corrective Actions

2.7.2.1. 10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:

2.7.2.1.1. a) React to the nonconformity and as applicable:

2.7.2.1.2. b) Evaluate the need for actions to eliminate the cause (s) of the nonconformity, in other that it does not recur or occur elsewhere by:

2.7.2.1.3. c) Implement any actions needed

2.7.2.1.4. d) Review the effectiveness of any corrective actions taken

2.7.2.1.5. e) Update risks and opportunities determined during planning, if necessary

2.7.2.1.6. The Corrective Actions shall be appropriate to the effects of the nonconformities encourtered

2.7.2.2. 10.2.2 The Organization shall retain documented information as evidence of:

2.7.2.2.1. a) The nature of the nonconformities and any subsequent actions tacken

2.7.2.2.2. b) the result of any corrective action

2.7.3. 10.3 Continual Improvement

2.7.3.1. The Organization shall continually improve the suitability, adequacy and effectiveness of the QMS

2.7.3.2. The Organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addresses as part of continual improvement