Quality Management System. Manual MASTER COPY

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Transcription:

Quality Management System Manual MASTER COPY

Revisions: Date Summary Rev. July 2010 14 Oct 2010 28 Jan 2011 9 Feb 2011 9 June 2011 6 March 2012 11 July 2013 13 July 2017 Initial Draft Issued Minor changes Minor changes Process interaction added Minor amends Add appendix amend wording Amend ISO9001:2015 wording and references. Amend Scope 0 1 2 3 4 5 6 7 1.0 Contents Section Title Page 1.0 Manual Contents (This page) and Introduction 2 2.0 Manual Approval and Amendment Control 3 3.0 Quality Management System Structure 4 4.0 Business Process 5 5.0 Quality Management System Interaction Diagram 6/7 6.0 Quality Management System Procedures 8 7.0 Documentation Structure 9 8.0 Quality Policy Statement 10 9.0 Organisation Chart 11 10.0 Business Plan 12 INTRODUCTION DATA HQ LTD has developed and implemented a quality management system based upon the requirements of ISO 9001: 2008 to provide its customers with the necessary quality assurance. Within this system the company s scope of ISO9001 registration has been defined as follows: The company undertakes the provision and distribution of Marketing Data and Data Marketing Services to both Public and Private Sector Organisations.

The company DATA HQ LTD defines the quality management system as all those planned and systematic activities which are necessary to provide adequate confidence in the achievements of the required quality. This system is dynamic, it changes when necessary to accommodate new techniques and products initiated by technological advancements and also the company s continuous improvement programmes. This manual details the management policies, objectives, responsibilities and authorities required to achieve the objectives set out by DATA HQ LTD. 2.0 Manual Approval and Amendment Control 1. This manual is reviewed and updated as required. Any employee of DATA HQ LTD. supplier or customer shall have the authority to request revision of the manual as part of the company s continuous improvement policy. 2. The Quality Manager (where appropriate, with the advice of a Quality Consultant) has the responsibility and authority to approve this Quality Management System Manual and all amendments made to it. All changes shall be recorded on the Amendment Record Sheet. Also, for raising any controlled documents within the QMS system. 3. One controlled copy of the Quality Management System Manual shall be printed and retained in the Office of DATA HQ LTD. Read only access to an electronic version of the Quality Management System Manual shall be available throughout the company via the computer system in the folder identified as QMS Staff folder (QMS Active). 4. Uncontrolled copies of the Quality Management System Manual may be issued for information purposes to customers and other third party personnel upon authority of the Quality Manager. 5. All such uncontrolled copies shall be duly identified, in red on each page as UNCONTROLLED COPY.

3.0 Quality Management System Structure DATA HQ LTD, have a formal documented quality management system clearly defining the objective, method and scope of each activity within the organisation. The quality management system is designed to satisfy the requirements of ISO 9001: 2015 along with any other quality system requirements prescribed by any customers. It should be noted that DATA HQ LTD do not undertake design,(8.3), therefore excluded any reference to these element s of the standard from this quality manual and the relevant supporting documentation. The quality system includes, but is not limited to: Quality Policy Procedures Reference Samples and Work Aids, where applicable The authorising signatory for these documents is the Quality Manager of DATA HQ LTD (when/where appropriate with the advice of the Quality Consultant). The processes further ensure that plant, facilities and equipment planning are addressed, and further to this the processes ensure that continual improvement is addressed. Where applicable, reference has been made to the relevant ISO 9001: 2015 clause and other reference manuals. The system and processes at DATA HQ LTD are dynamic and shall be improved as required in pursuit of the company objectives. If a new process is introduced to the QMS then the Quality Manager with the management team will define appropriate measure(s) to monitor the process performance. Customer confidentiality is assured and shall be maintained at all times. Should any customer place DATA HQ LTD on Needs Improvement status, the certification body will be informed in writing within five working days by the Quality Manager. All undertaken at the company s premises at: Hyatt Place, 50-60 Broomfield Road, Chelmsford, Essex, CM1 1SW

4.0 Business Processes DATA HQ LTD have recognised the following key processes as being fundamental to their business management system, all are interrelated and a diagram showing this relationship is featured on page 6 of this manual. A brief explanation on the function of each of the processes follows, it should be noted that each of the processes generates records which are controlled as detailed in section 4.2.4 of ISO 9001:2015 Business Development is focussed upon processing customer enquiries onto the quotation stage and the subsequent customer liaison that is generated. At DATA HQ LTD Business Development plays a key role within the company. Business Planning Ensures that the long, medium and short term development of the company is clearly define by objectives and budget provision for all aspects of DATA HQ LTD, and that these are reflected in the Business Plan. Continuous Improvement is recognised as a major requirement of ISO 9001: 2015 and that its effective implementation is controlled by the Quality Operating System, Management Review Meetings, and Customer Satisfaction Surveys. Human Resources by selective recruitment and effective training, ensure that People Development addresses the current and future needs of DATA HQ LTD, whilst conformance to the law and best practise disciplines are met. New Product and Process Development Ensures that the development of new techniques along with the design and development of any new processes. Plant, Facilities and Equipment Management provides the necessary support through predictive maintenance, preventive maintenance, and equipment design to enable product to meet customer specifications. Further support is provided through site services, Health & Safety, and protection of the Environment. Quality Support Is provided by the Quality Manager and a Quality Consultant, who provides the audit schedule, QA systems and documentation. Continual improvement activities are monitored by regular KPI analysis and concern resolution. Purchasing encompasses the activities undertaken on behalf of DATA HQ LTD, along with the assessment, monitoring and development of all key suppliers to the company.

5.0 Quality Management System Interaction Diagram Continual Improvement of the Quality Management System Customers Management Responsibility Customers Resource Management Measurement, Analysis and Improvement Satisfaction Requirements Input Product Realisation Product Provision Output Value-adding activities Information flow

Process Interaction Company s Overall Aims & Goals Initial Preparatory Review Customer Requirements Codes of Practice Legislation Quality Manual Documented Management System Supply and Distribution of marketing data Evidential Records Change, Issue and Distribution Control Management Review New targets And objectives Audit Results Customer Complaints Customer feedback Reports Supplier Performance Staff Competency and training Corrective and Preventive actions Opportunities for improvement Resources Continual Improvement Programme Enhanced Customer Satisfaction

6.0 Quality Management System Procedures To facilitate delivery of product and services to customer requirements DATA HQ LTD, have identified the following procedures to ensure adequate control and definition for its key processes. As the system is dynamic these procedures are subject to change and addition as necessary to ensure compliance with the standard and current customer requirements. REF No. TITLE ISO 9001: 2015 Element(s) D-HQ-0000 Quality Manual 4.2.2 D-HQ-0000 Quality Policy Statement 4.2.1, 5.3, D-HQ-1000 Customer Satisfaction Procedure 8.2.1, 8.2.1.1 D-HQ-1001 Control of Non-conformance 7.5.3, 8.3, 8.3.1, 8.3.2, 8.3.3 D-HQ-1002 Internal, Product and Process Audits 7.5.1.2,8.2.2, 8.2.2.1,8.2.2.2, 8.2.2.3, 8.2.2.4, 8.2.2.5, 8.2.3, 8.2.4 D-HQ-1003 Sales Enquiry Procedure 7.2.1, 7.2.2, 7.2.3 D-HQ-1004 Control of Records Procedure 4.2.1, 4.2.4, 4.2.4.1 D-HQ-1005 Production Procedure 7.5 D-HQ-1006 Purchasing Procedure 7.4.1, 7.4.2, 7.4.3.2 D-HQ-1007 New Employee Induction and Training 4.2.1, 6.1, 6.2.1, 6.2.2.1 D-HQ-1008 Supplier Approval Procedure 7.6.3.2 D-HQ-1009 D-HQ-1010 Customer Complaints Procedure 8.4, 8.4.1, 8.5.1, 8.5.5.1, 8.5.2.3 D-HQ-1011 System Back up D-HQ-1012 Document Control Procedure 4.2.3, 4.2.3.1 D-HQ-1013 Corrective Action Procedure 8.5.2, 8.5.2.1, 8.5.2.3 D-HQ-1014 Preventive Action Procedure 8.5.3, D-HQ-1015 Management Reviews 8.4, 8.4.1, 8.5.1, 8.5.5.1, 8.5.2.3

7.0 Documentation Structure 1. The levels of documentation are shown in the diagram below and are described in further detail in sections 7.1, 7.2, and 7.3. Level 1 Quality Management System Manual Level 2 Quality Management System Procedures Level 3 Quality Records, Forms and Associated Documentation 7.1 Quality Management System Manual (Level 1) 1. The Quality Management System Manual defines the structure of the documented quality management system and references the system procedures and other processes. 7.2 Quality Management System Procedures (Level 2) 1. The Quality Management System Procedures define who carries out specific functions and also what, where, when these functions are to be used. 2. The system procedures are uniquely numbered so as to cross-reference to the applicable standard. 7.3 Records, Forms, Associated Documentation (Level 3) 1. Records, Forms and Associated Documentation are maintained to demonstrate conformance of the product, to the specified requirements, as well as the effective operation of the quality management system. 2. The Records, Forms and Associated Documentation are used in support of the system procedures. Document Ref Version Date Approved By Page D HQ-0000 7 19/03/2017 DIRECTOR 12 of 12