Quality Manual. ISO 9001:2008 Standard. Issue No - 3. April

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1 Quality Manual ISO 9001:2008 Standard Issue No - 3 April COPYRIGHT: Renaissance Services-CSG owns the copyright of this document. It may not be copied, reproduced or transmitted in any form without the express permission of the CEO. Issue No CEO 1 of 29

2 Copy Issue Status All internal issues shall be controlled copies. Copies issued externally shall be uncontrolled and therefore will not be subject to automatic update should changes occur. Controlled Copy # Issued To: Designation: Uncontrolled Copy (External Issue) N/A COPYRIGHT: Renaissance Services-CSG owns the copyright of this document. It may not be copied, reproduced or transmitted in any form without the express permission of the CEO. Issue No CEO 2 of 29

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4 Contents 1.0 Contents Introduction to Quality Assurance Manual Scope of Quality Management System Introduction to Renaissance Services-CSG Renaissance Services-CSG Management Commitment Quality Policy: Quality Objectives: Quality Management Structure Site Quality Management Steering Committee Structure (SQMSC) Site Quality Organisation Company Organisation Structure Document Structure Quality Management System - Process Map Quality Management System General Requirements Documentation Requirements General Quality Manual Control of Documents Control of Records Management Responsibility Management Commitment Customer Focus Quality Policy Planning Quality Objectives Quality Management System Planning Responsibility, Authority and Communication Responsibility and Authority Management Representative Internal Communication Management Review General Review Input Review Output Issue No CEO 4 of 29

5 6.0 Resource Management Provision of Resources Human Resources General Competence, Awareness and Training Infrastructure Work Environment Product Realization Planning of Product Realization Customer-related Processes Determination of requirements related to the Product Review of requirements related to the Product Customer Communication Purchasing Purchasing Process Purchasing Information Verification of Purchased Product Product and Service Provision Control of Production and Service Provision Validation of Processes for Production and Service Provision Identification and Traceability Customer Property Preservation of Product Control of Monitoring and Measuring Devices Measurement, Analysis and Improvement General Monitoring and Measurement Customer Satisfaction Internal Audit Monitoring and Measurement of Processes Monitoring and Measurement of Product Control of Non-conforming Product Analysis of Data Improvement Continual Improvement Corrective Action Preventive Action List of Quality Assurance Procedures Level 2 Documentation Issue No CEO 5 of 29

6 Foreword The ISO (International Organization for Standardization) is a worldwide federation of national standard bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for whom a technical committee has been established has the right to be represented on that committee. International Organizations, Governmental and Non- Governmental in liaison with ISO also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of Electrotechnical Standardization. International Standards are drafted in accordance with the rules given in ISO/IEC Directives Part 2. The main task of Technical Committees is to prepare International Standards. Drafted International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75% of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be subject of patient rights. ISO shall not be held responsible for identifying any or all such rights. ISO 9001 was prepared by Technical Committee ISO/TC 176, Quality Management and Assurance, Sub-committee SC-2, Quality Systems. This third edition cancels and replaces the second edition (IS) 9001: 2008, which has been amended to clarify points in the text and to enhance compatibility with ISO 14001:2004. Issue No CEO 6 of 29