Quality Manual

Document Number AD-QM Date 24-Apr-12 Revision No 1 Page 1 of 26 Company Internal

ISO 9001:2008 Quality Manual

Revision 1.0

Prepared by Reviewed by Approved by

XYZ Company
Address:

The contents of this Manual and the related documentation are confidential to the company and should not be reproduced or copied, either in part or full nor issued to third party without prior approval of the XYZ Company

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Quality Manual Amendment Sheet

Sl. No

Date

Page Number

Revision Status Old New

Amendment Details

Sign of MR

List of Controlled Copy Holders

Copy Holder Management Representative Library Copy Certifying Body Copy No -01 02

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Table of Contents
INTRODUCTION ............................................................................................................. 5 QUALITY ........................................................................................................................ 5 SCOPE............................................................................................................................ 6 Exclusions: ......................................................................................................................... 6 QUALITY MANAGEMENT SYSTEM .............................................................................. 7 General requirement ........................................................................................................ 7 Documentation requirements .......................................................................................... 7 MANAGEMENT RESPONSIBILITY ............................................................................. 10 Management Commitment ............................................................................................ 10 Customer focus ................................................................................................................ 10 Planning ........................................................................................................................... 10 Quality management system planning .................................................................. 10 Quality objectives ................................................................................................. 11 Responsibility, Authority and communication ............................................................ 12 Responsibility Matrix ..................................................................................................... 14 Management Representative ................................................................................. 16 Internal Communication ....................................................................................... 16 Management Review ....................................................................................................... 17 RESOURCE MANAGEMENT ....................................................................................... 18 Provision of resources ..................................................................................................... 18 Human Resources ........................................................................................................... 18

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PRODUCT REALIZATION ........................................................................................... 20 Planning of PRODUCT realization ............................................................................... 20 Customer Related Process .............................................................................................. 20 Procurement .................................................................................................................... 21 PRODUCTION & SERVICE PROVISION ................................................................ 22 MEASUREMENT, ANALYSIS AND IMPROVEMENT .................................................. 24 General ............................................................................................................................. 24 Monitoring and measurement ....................................................................................... 24 Control of Non-Conformities ......................................................................................... 25 Analysis of Data............................................................................................................... 25 Improvement ................................................................................................................... 26

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INTRODUCTION

QUALITY

Date: Place:

XYZ Company is committed to delivering enhanced value to customers, through continual improvement of processes and systems by way of innovation, technology and knowledge management.

Authorized Signatory

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SCOPE

EXCLUSIONS: DESIGN AND DEVELOPMENT

Design and development has been excluded as Organization does not conduct any design activities. Exclusions of the above clauses do not affect the organizations ability and responsibility to provide products that meets customer, statutory and regulatory requirements.

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QUALITY MANAGEMENT SYSTEM

GENERAL REQUIREMENT

The Organization has established documented, implemented, maintained and would continually improve the Quality Management system in accordance with the requirements of ISO 9001:2008 International standard. The Organization has determined the processes for Quality Management System and their application throughout the organization. The Organization has determined the sequence and interaction of these processes with the criteria and methods required to ensure the effective operation and control of these processes. The Organization has ensured the availability of resources and information necessary for the process and measures monitors and analyzes these processes and implements action necessary to achieve planned results and continual improvements.

DOCUMENTATION REQUIREMENTS GENERAL

The Quality System is organized into the following elements. Quality Policy A Quality Statement prefaces the Quality Manual. This outlines the objectives of the Quality System and the companys commitment to Quality. The QMS Manual by the company is documented in the following levels of Documentation . Level 1: QMS Manual. This addresses the requirements stated in the ISO 9001:2008 Standards as applicable to the process followed in the ABC Company. Level 2: Quality System Procedures as required by the organization and standards

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Master List of System related Procedures are as mentioned here below. Procedure for Control of Documents Procedure for Control of Records Procedure for Internal Quality Audit Procedure for Control of Non Conforming Product Procedure for Corrective / Preventive Action AD-QSP1 AD-QSP2 AD-QSP3 AD-QSP4 AD-QSP5

Level 3: Process related Documents like Drawings, Forms and registers as required by ISO 9001:2008 and suitable for effective planning, operation and control of its processes Level 4: Records required by the standard and the process
QUALITY MANUAL

The Organization has established and maintained Quality Manual that includes Scope of the QMS including details of exclusion and its justification Documented procedures established for the or reference to them Description of the Interaction between the process and QMS.

CONTROL OF DOCUMENTS

The process for controlling the documents and amendment within the organization is explained in the Procedure for Control of Documents. Details of Amendments in Quality Manual, System procedures and any other documents are recorded in the Document Amendment list. Current Revision status of all Documents starts from 1 and subsequent changes will be 2, 3 and so on. Current Issue status of Quality Manual is 1.0. If the current status of the manual is x.y, minor changes will lead to increment in y and major changes will lead to increment in x. After 10 continuous minor changes or after 2 years of no major changes, the revision will have a mandatory increment in x. All documents are ensured that they are legible and easily identifiable. The Quality Manual is identified as AD-QM and the page numbering is done at the header of each page.

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The Organization has ensured that Documents of External origin necessary for the planning and operation of the quality management system are identified and their distribution controlled. Reference: Procedure for Control of Documents AD-QSP1
CONTROL OF QUALITY RECORDS

The Organization has established the records required for the Quality management system, which has been controlled. All records are maintained to provide evidence of conformance and of effective operation of the Quality management system. Records are maintained in either Hard copies or soft copies. Procedure has been established for the identification, storage, protection, retrieval time, retention time and disposition of quality records. Records are maintained legibly, identifiable and retrievable Reference: Procedure for Control of Records AD-QSP2

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MANAGEMENT RESPONSIBILITY

MANAGEMENT COMMITMENT

The Quality Management System has been implemented and its effectiveness is controlled by continual improvement and by Communicating to the organization the importance of meeting customer as well as statutory & regulatory requirements. Establishing the quality policy. Establishing Quality Objectives. Conducting Management Review meeting. Ensuring availability of necessary resources

CUSTOMER FOCUS

The Organization ensures that customer needs and expectations are determined through interactions and feedbacks. The requirements of customers are fulfilled with the aim of achieving customer satisfaction.

PLANNING

QUALITY MANAGEMENT SYSTEM PLANNING

The Organization has ensured that the planning of the Quality Management system is carried out to meet all requirements as well as Quality objectives and integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

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QUALITY OBJECTIVES

The Quality Objectives has been established at relevant departmental level within the Organization. This is tangible and consistent with Quality Policy. S No 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. Department Objectives

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RESPONSIBILITY, AUTHORITY AND COMMUNICATION

The Responsibility & authorities are defined below. In addition to this Job Responsibilities are issued to all the persons. Responsibilities of Designation 1. Monitoring the Resource requirements 2. Ensuring that the company meets all statutory and regulatory requirements. 3. Chairing Management review meeting. 4. In-charge of Marketing activities 5. Handling customer enquiries and complaints 6. Reviewing the requirements of customer. 7. Sending Quotations to enquiries received 8. Overall operations of the company. 9. Implementing QMS in the company. 10. Member of the Management Review. 11. Identifying Training Needs and requirement of Resources. 12. Recruitment of New Employees. 13. Conducting Internal Quality Audits at regular intervals 14. Responsible for Document and record control. 15. Coordinating with the vendors 16. Coordinating with the vendors for replacement of any faulty item found. 17. Vendor Selection and Annual Re-Evaluation. 18. Raising Purchase orders from the Approved Suppliers List and subsequent approval from Director.

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Authority of Designation 1 2 3 4 5 Approval of all QMS related Documents Approval of Purchase Orders for capital equipments. Approval of Deliverables Deciding on the disposition of non conforming products during delivery process and customer returns Approval of new contracts.

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RESPONSIBILITY MATRIX

ISO 9001 : 2008 Reference

Document & Record Control QMS Planning Quality Policy and Objectives MR Functions Management Review Meeting Resource Requirements Human Resources Maintenance Marketing Purchasing Verification of Purchased Product Production Service, Installation Identification & Traceability Customer Property Packing and Stores Calibration Continual Improvement

Designation

Designation

Designation

Designation

Designation

Designation

Designation

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Customer Satisfaction Internal Auditing. Process Measurement and Controls Product Measurement Control of Non Conforming Product Data Analysis. Corrective and Preventive Actions P Primary Responsibility; S Secondary Responsibility; A - Authority

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MANAGEMENT REPRESENTATIVE

Management has appointed Name of the member a member of the organization as the Management Representative who irrespective of other responsibilities and authorities has to Ensure that processes needed for the QMS are established, implemented and maintained by frequent internal audits and Management Review. Ensuring the promotion of awareness of customer requirements throughout the organization. Liaison with external bodies regarding QMS. Appraisal on the performance of QMS and any need for improvement to the Management.

INTERNAL COMMUNICATION

The M.R has ensured that communication between its various levels and functions regarding the process of the Quality Management System are effectively carried out and effectiveness is checked through management review meetings. Internal Communication is done by means of review meetings, Information display on the Notice Board and e-mail notifications.

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MANAGEMENT REVIEW
GENERAL

Top management reviews Quality Management system every 6 Months. This is conducted to ensure the continuing suitability, adequacy and effectiveness of QMS. Opportunities are also identified during these meeting for improvement and need for any changes in the QMS including the Quality Policy, Quality objectives and customer complaints and feedbacks.
REVIEW INPUT

Review Inputs includes current performance and improvements opportunities related to: Results of audits. Customer feedback. Process performance and product conformance. Status of preventive and corrective action. Change that could affect the quality management system. Follow up action from previous management review. Recommendations for improvement.

Agenda is prepared by MR and circulated to all the attendees before MRM. Reference: Agenda of Management Review Meeting
REVIEW OUTPUT

Review Output includes, actions related to Improvements of the quality management system and its process Improvement of product related to customer requirements Resource needs

Review outputs are recorded in the minutes of management review meetings and copies circulated to all members. Reference: Minutes of the Management Review Meeting

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RESOURCE MANAGEMENT

PROVISION OF RESOURCES

The resources needed are determined and provided in timely manner to: Implement and improve the process of the quality management system Address customer satisfaction.

HUMAN RESOURCES GENERAL

The Organization has ensured that personnel who are assigned responsibility defined in the QMS are competent on the basis of applicable education, training, skills and experience.
COMPETENCY, TRAINING AND AWARENESS

The organization identifies the competency needs for personnel performing activities affecting quality by means of Skill Matrix. Based on Skill Matrix and training needs Training Calendar is prepared for the year. Providing training to satisfy these needs and evaluate the effectiveness of training provided. Maintain appropriate records of education, training, skills and experience. The Organization also ensures that personnel are aware of their job description and their contribution to the achievement of Quality Objectives.

INFRASTRUCTURE

The company activities are carried out in a spacious building. Computers with Local Area Network, Internet connection, phone and Fax are available. List of assets is prepared and all the assets are maintained by respective personnel.

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WORK ENVIRONMENT

The Organization has provided a work environment as per statutory requirements. In addition to physical factors, other factors like temperature, humidity, noise and human element is crucial as regards to the company is concerned and hence a good layout which enable safety; proper illumination, Exhaust fans, First Aid Box, Fire Extinguishers, Smoke detectors are provided. The work place is well illuminated and also has Generator to take care of the power shutdown.

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SERVICE REALIZATION

PLANNING OF PRODUCT REALIZATION

The Organization has determined the planning process for realization of product: Determined the Quality Objectives and requirements of the product. Establish processes and documentation and provide resource and facilities specific to the product. Establish process for verification and validation, monitoring, inspection activities and the criteria for acceptability. Records necessary to provide evidence of conformity of the process and the resulting product meets customer requirements.

CUSTOMER RELATED PROCESS DETERMINATION OF THE REQUIREMENTS RELATED TO THE PRODUCT

The Organization has implemented systems to determine that the customer requirements including Product requirements specified by the customer, including the requirements for availability, delivery and support. Product requirements not specified by the customer but necessary for intended use or specifics. Obligations related to product, including statutory, regulatory and any other requirements.

Reference: Customer Enquiry Register

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REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT

The Business Development department reviews the requirements of the Customer related to the product. This review is done after receiving an order. The review would cover all Technical and Commercial Aspects. In case of change in product requirements, the organization ensures that relevant documents are amended and relevant personnel informed. As the Order is confirmed the Business Development department initiates the order processing.

Reference: Contract Review

CUSTOMER COMMUNICATIONS

The Organization has implemented effective arrangements for communicating with the customer through different Medias such as Telephone, Fax, website and email; Courier / Postal Product with regards to Enquiry, Product Information, Contracts, Amendment, Customer Feedback and Complaints.

PROCUREMENT PROCUREMENT PROCESS

An Indent is raised by the required Dept. based on the needs the Managing Director defines the procurement and ensures that it conforms to the requirements. Indent is raised by relevant department HODs. Analysis is carried out as per the need. A List is maintained with details of suppliers and service providers including Subcontractors. Evaluation of all suppliers is carried out before empanelling them Re-evaluation of suppliers is done every year.

Reference: Approved Supplier List F23, Supplier Re-evaluation F24

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PROCUREMENT INFORMATION

Any procurement is conveyed to the Managing Director in the Indent in line with the Bill of Material. Purchasing information is communicated to the supplier through Purchase Order, wherein the requirements for the materials/services, delivery and commercial terms are clearly defined. The Purchasing Dept. prepares the Purchase order. Amendments if any are subsequently informed to the supplier with amendment details mentioned in the Purchase Order.

Reference: Purchase Order

VERIFICATION OF PROCURED PRODUCT/SERVICES

All products/services procured are checked for Quantum by Admin department and recorded in the Register. The Admin department inspects all incoming materials in line with the ordered specification, Admin Department will also preserve all warranty certificates of these equipments.

PRODUCTION & SERVICE PROVISION CONTROL OF PRODUCTION & SERVICE PROVISION

The Organization has provided information related to product in the form of schematics, and work instructions, required for carrying out the sourcing, interviewing and staffing process. Quality check activity is carried out by Business Heads at each & every step of product delivery.

VALIDATION OF PROCESS FOR PRODCUTION & SERVICE PROVISION

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The Organization has established validation process to review and approve processes and procedures with respect to equipments, Operators and other personnel involved in the activities that affect Quality of the product, generate relevant records and revalidate annually.

IDENTIFICATION AND TRACEABILITY

Items in the work place are kept as per pre-designated places earmarked and Items in the stores are kept in appropriate bins / Racks with identification. Products are identified by Product numbers & details related to that Product is preserved in relevant files.

Reference: List of Products

CUSTOMER PROPERTY

The Organization receives inputs and specifications for reference and provision of solutions with respect to physical security. All care is taken to ensure that the items and information under the custody of the organization are secured against theft or damage during internal processing. If any item is found to be damaged or lost during the processing the same is informed to the customer.
PRESERVATION OF PRODUCT

The organization preserves the conformity of product throughout the process cycle. All Customer information are suitably identified, handled, stored and protected against damage.
CONTROL OF MONITORING AND MEASURING EQUIPMENT

The Organization has determined and undertaken monitoring & measuring of equipments needed to provide evidence of conformity & has ensured in a manner that it is consistent with monitoring & measuring requirements of products to determine requirements. All measuring equipments are calibrated and verified periodically prior to use against measurement standards traceable to international or national measurement standards, where no such standard exist the basis for calibration or verification is recorded. All equipments have identification in order to trace its calibration status.

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Is safe guarded from adjustments that would invalidate the measurement result and protect it from damage and deterioration during handling, maintenance & storage.

MEASUREMENT, ANALYSIS AND IMPROVEMENT

GENERAL

The Organization has planned and implemented the monitoring, measurement analysis and improvement process needed to Demonstrate conformity of the product. Ensure conformity of the QMS Continually improve the effectiveness of the QMS. Determine and implement statistical techniques for Data Analysis.

MONITORING AND MEASUREMENT CUSTOMER SATISFACTION

The Organization has obtained information about the customers perception as to whether the company has met the requirements after delivery. The feedback includes parameters on Quality, Delivery, and service. Information derived from this has been reviewed and discussed in the Management Review Meeting Customer feedback is collected from major customers at a frequency of 1 year. Feedbacks collected are reviewed and action initiated. The customer feedback is reviewed on receipt and the index is calculated. The Sales department resolves customer Complaints requiring immediate attention.

Reference: Feedback Form

INTERNAL AUDIT

The Organization has established methods for conducting internal quality audits at every six months to determine whether the quality management system conforms to the planned arrangements to the requirements of the ISO 9001:2008 standard and to the quality

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management systems established by the organization and is effectively implemented and maintained. Reference: Procedure for Internal audit
MONITORING AND MEASUREMENT OF PROCESSES.

The Organization adopts methods for monitoring the QMS processes. These processes demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, appropriate corrections and corrective actions are initiated, to ensure conformity of process and product.

MONITORING AND MEASUREMENT OF SERVICE

Regular checks are carried out delivery team. Regular feed backs are recorded from the customer.

Reference: Project Sign-off Record

CONTROL OF NON-CONFORMITIES

The Organization has taken care to ensure that Nonconformance in the service is reduced or eliminated. Disposition of Nonconformities is carried out by the delivery team in-charge in liaison with Production Manager. Reference: Procedure for Control of Non-Conforming Product

ANALYSIS OF DATA

The Organization collects data, analyze and display appropriately in order to meet the Quality Objectives and demonstrate the suitability and effectiveness of Quality Management System. Data Analysis is directed towards Enhancing Customer Satisfaction. Increasing the Quantum of Service Conformity to Service Requirements. Suppliers

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Characteristics of Processes and products including opportunities for Preventive action.

All this data would be in the form of visual display like Bar chart, Graph or Pie chart.

IMPROVEMENT
CONTINUAL IMPROVEMENT

The Organization continually improves the effectiveness of the QMS through the declared documents of Quality policy and Quality objectives, Audit Results, Data Analysis, Corrective and Preventive Action and Management Review.
CORRECTIVE ACTION

The Organization has established methods to take action to eliminate the causes of Non Conformities in order to prevent recurrence. The corrective actions are appropriate to the effects of the Non-Conformities encountered. Effectiveness of the Corrective action initiated is reviewed Reference: Procedure for Corrective and Preventive Action
PREVENTIVE ACTION

The Organization has established methods to determine actions to eliminate the causes of potential non-conformities in order to prevent their occurrence and recurrence. Preventive actions are appropriate to the effects of the potential problems. Effectiveness of the preventive action initiated is reviewed. Reference: Procedure for Corrective and Preventive Action