Iso 90012008 QMS

AUTHORISED HOLDER : ISSUE NUMBER : COPY NUMBER :
01
01
QUALITY MANUAL
( ISO 9001 : 2008 )
This Document states the Organisations Quality Policy and describes the Quality Management Systems adopted for assuring quality and services for
Concept Dental Care Centre

This is a controlled document if it bears controlled copy stamped in Red. Unauthorised access, copying and replica are prohibited. This document must not be copied in whole or part by any means, without the written authorization from MR / PROPRIETOR
Section 0.1 : Revision No. : 00,
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QUALITY MANUAL
Doc. No. : AMV/QM/01

ISO Sec. QM Sec. No. No. 0.1 0.2 0.3 0.4 1.0 2.0 5.3 3.0 4.0 4.0 Annex.A Annex.B Annex.C Annex.D Annex.E 5.0 5.0 Annex.G 6.0 6.0
Revision No. : 00 Section : 0.2 Page : 1 of 1 CONTENTS DATE : DESCRIPTION No. of Rev. Pages No.
Cover Sheet Contents Amendment Record Sheet Scope, Approval and Distribution Organization Profile Permissible Exclusions Quality Policy Quality Management System Sequence & Interaction of processes of QMS Responsibility & Authority Process Flow Chart Organization Chart Criteria & Objectives of Processes for QMS Management Responsibility Quality Management System Planning Resource Management Product Realization Planning of Product Realization Patient related processes Design and Development Purchasing 1 1 1 1 1 1 1 3 1 2 1 1 1 4 1 2 8 1 2 2 2 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
7.0 7.1 7.2 7.3 7.4
7.0 7/7.1 7.2 7.3 7.4
7.5
8.0
7.5
8.0
Production and Service provision

Measurement, Analysis and Improvement
2
5
00
00
ISSUED BY ( M.R.) APPROVED BY (PROPRIETOR)
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ISSUE NUMBER : 01 Doc. No. : AMV/QM/01 Revision No. : 00 Section : 0.3 Page : 1 of 1
QUALITY MANUAL

Remove (OLD) Page Rev No. No.
MANUAL AMENDMENT RECORD SHEET
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SEC. NO.
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Nature of Change
Signature of copy holder & Date
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ISSUE NUMBER : 01
QUALITY MANUAL
Doc. No. : AMV/QM/01
SCOPE, APPROVAL & DISTRIBUTION
Revision No. : 00 Section : 0.4 Page : 1 of 1 DATE : -
SCOPE OF QMS
This Quality Manual describes the Quality Management System (QMS) established and implemented by Concept Dental Care Centre to meet the requirements of International Standard ISO 9001: 2008 through sections 4.0 to 8.0 and to consistently provide product / service that meets Patient and applicable regulatory requirements. QMS, which is Patient focused, aims to enhance Patient satisfaction through the effective application of the system and the processes for its continual improvement and the assurance of conformity to Patient and applicable regulatory requirements. Our all out sourced processes comply with legal and Patient requirements 2. The Scope of Quality Management System which covers all aspects and facets of Professional dental treatment with latest and most modern techniques in the field of Dental Surgery and Oral Health Care
APPROVAL OF QUALITY MANUAL

The Quality Manual, approved by PROPRIETOR, describes the QMS based on the requirements of ISO 9001:2008 which are complementary to technical requirements of the products, adopted as a strategic decision, implemented and practiced by Concept Dental Care Centre PROPRIETOR approves this Quality Manual and organisation is committed : to diligently practice the QMS and thus to serve Patients with great & prompt responsiveness . to enhance Patients satisfaction by meeting their requirements & expectations besides complying with relevant statutory and legal obligations. to establish, implement and review the quality policy and its objectives, with a view to ensuring their continuous suitability through improvements as necessary. to make available all necessary resources including providing an infrastructure of facilities for achieving this purpose of Community Oral Health Care. DISTRIBUTION The Manual, its copies or extract from it, must not be passed on to any person without the written permission of the PROPRIETOR / M.R. of Concept Dental Care Centre 1. Unnumbered / Uncontrolled copies may be given to Patient / Outside agencies purely for information purpose. UNCONTROLLED copies are not covered under change control but are current at the time of issue. 2. The CONTROLLED copies are covered by change control and are stamped in red on all pages. It is the responsibility of copyholder of this Manual to maintain and incorporate all revision on receipt and keep it up to date. The controlled copies are distributed as under : A. Copy no. 1 Master Copy M.R. (Shared by PROPRIETOR) B. Copy no. 2 Auditor
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QUALITY MANUAL
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ORGANISATION PROFILE
Section : 1.0 DATE : -
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The Concept Dental Care Centre was established in the year for Provision of Professional dental treatment with latest and most modern techniques in the field of Dental Surgery and Oral Health Care The Dental Care Centre is being run and managed by the technical and experienced professionals having a wide experience in the various areas of their specialization. The company employs well-qualified individuals, who are capable enough to perform their work and related quality functions. The company has installed the requisite equipment to meet the requirements of Dental Patients and deliver them required services. Concept Dental Care Centre has the entire infrastructure required for Dental Surgery and Occupies a significant place as a reputed Dental facility of Hardwar.
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QUALITY MANUAL PERMISSIBLE EXCLUSIONS
The following requirement of the ISO 9001-2008 neither affects the organizations ability nor absolves it from its responsibility, to provide service that meets Patient and applicable regulatory requirements. The exclusions are limited, depending on type of product / service, Patient requirements and applicable regulatory requirements. For Example 1. Design & Development (ISO 9001 : 2008 Clause No. : 7.3 ) This activity is restricted to the design of Storage Tank, the hydraulic and Pneumatic System, It does not involve design of Vehicles on which storage tank is mounted
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QUALITY MANUAL QUALITY POLICY
Doc. No. : AMV/QM/01 Revision No. : 00 Section : 3.0 Page : 1 of 1
DATE : -
QUALITY
POLICY
Concept Dental Care Centre is committed to enhance Patient satisfaction by identifying & fulfilling patients needs of Oral Hygiene We work as a team of a motivated work force with an aim of continual improvements in the quality management system & procedures. We endeavor to augment our infrastructure and provide training to our personnel to emerge as Leading Dental Surgeon of Uttrakhand
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ISSUE NUMBER : 01
Doc. No. : AMV/QM/01 QUALITY MANUAL Revision No. : 00 QUALITY MANAGEMENT SYSTEM Section : 4.0 Page : 1 of 3 DATE : -
4.0
QUALITY MANAGEMENT SYSTEM General Requirements.
The Organization has established the QMS for smooth & efficient working of the organisation covering all important functions and their interaction to supply the quality products & services to the Patient and continuously improve its effectiveness in accordance with the requirements of ISO 9001:2008 standards. a) The processes important for the Quality Management System and their application throughout the organisation are identified. b) The flow of sequence of processes, their interaction and relationship are identified. c) Criteria for the effectiveness of control and monitoring system of the various processes are determined and reviewed during Management Review Meeting, Internal Quality Audits and in other departmental meetings. The stress is to ensure that they are effective, dynamic with time modulated with changing system needed. d) The management is committed to provide all necessary resources in terms of manpower, machines & equipments, materials and extend full support for smooth percolation of information necessary to ensure that all processes are adhered to and comply with the systems requirement. e) The organisation defined a system of monitoring and recording of various process parameters as deemed necessary to maintain the quality of the product. The exact natures of the records are dealt with in the respective process clauses addressed in subsequent pages. The organisation gives due importance to the recording of information / data, as the analysis of these data are important for control and improvement in the product / service quality. f) The data obtained at various stages are analysed for trend and discussed to improve the overall performance of the organisation. The forums for discussions are departmental meetings, Management Review Meetings and Internal Quality Audits. Presently no any process is outsourced that affects product / service conformity with requirements, however if any process that affects product conformity is outsourced in due course of time then the same shall be identified and control over such process shall be ensured.
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4.2.1 Documentation Requirements- General The Organization chart and job descriptions of the key personnels define and document the level and responsibilities. QMS Documentation includes the following : a. The statement of the organizations Quality Policy is a part of this Quality Manual and is also displayed at places in the organisation. The Quality objectives are dynamic in nature and are reviewed in MRM. b. The Quality Manual, i.e. this manual, which specifies the policies of the organisation, details the scope of the QMS, exclusions with justifications. c. All documented procedures as specified by ISO 9001-2008 standard and those, which are necessary for smooth & effective working of the organisation, are addressed in Quality Procedure Manual along with the reference documents. d. All documents needed by the organisation to ensure the effective planning, operation and control of its processes are specified in the respective processes / procedures, such as Work Instructions, Specifications, Drawings etc, (Refer : Master list of Documents AMV/ML/01) e. All quality records as required by standard ISO 9001-2008 for effective operation and control of activities / processes are documented and maintained at the respective area of operations. 4.2.2 Quality Manual : The Quality Manual (this Manual) which is established and maintained, details the scope of the QMS, exclusions with justifications (Refer Section 2.0) & documented procedures or reference to them. It also describes the description of the interaction between the processes of Quality Management System.
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4.2.3 Control of Documents : All Documents of the Quality Management System are controlled. A documented procedure is established to cover the following : a. Approval of documents for adequacy by appropriates authority prior to issue. b. Review, updation and re-approval of documents by the respective issuing authority. c. Master lists (or similar) are established to identify the current revision status of all documents in the quality system. d. To ensure that relevant version of documents are available at the points of use i.e. with concerned person, at work place / machine, at area of activity being carried out etc. e. To ensure legibility and identifiably of the documents. f. Internally and externally generated documents that underpin the Quality system and which require monitoring for revisions and distribution are termed CONTROLLED and MR regulates their distribution. A master list of External Origin documents is maintained. (Refer : Master List CG/ML/09) g. The system also ensures that obsolete documents are removed from all points of issue or use. The removed documents are suitably marked as detailed in procedure. One copy of superseded / obsolete documents duly identified are retained to maintain specified or required traceability of the documents. 4.2.4 Control of Records : Quality records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. A documented procedure is established, for the Identification, storage, retrieval, protection, retention-period and disposition of all Quality Records. It is ensured that all quality records are legible, readily identifiable and retrievable. Records required, as evidence of conformance to requirements and for effective operation of Quality Management System are controlled. REFERENCE DOCUMENTS : Procedure for Control of Documents
Procedure for Control of Records Master List of Documents Master list of Records
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QUALITY MANUAL
SEQUENCE & INTERACTION
Annex. : A DATE : -
Page : 1 of 1
Sequence & Interaction of processes of QMS PROCESSES Sales (A) Purchasing (C) Store (F) Internal Audit (G) Management Review (H) ISO Clause No.
7.2.1 7.4 , 4.1 7.5.5
A Y Y Y Y
B Y Y Y Y Y
C Y Y Y Y
D Y Y Y Y Y
F Y Y Y Y Y
G Y Y Y Y Y
H Y Y Y Y Y
8.2.2 5.6
Y :- Interaction exists.
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RESPONSIBILITY AND AUTHORITY
QUALITY MANUAL
Doc. No. :AMV/QM/01
RESPONSIBILITY AND AUTHORITY
MANAGEMENT REPRESENTATIVE
1. Chief Executive has appointed -------------------as the Management Representative. In addition to his other responsibilities, he is authorised to carry out the following:
a) Ensuring that the quality system, meeting the requirements of ISO 9001: 2008 is established, implemented and maintained. b) Reporting on performance of Quality system to Partner (Chief Executive) for its review and improvements and maintaining liaison with external organizations on matters relating to Quality system. 2. 3. He reports to the top management on the performance of quality systems and promotes awareness of Patient requirements throughout the organization. He acts as the member secretary for the MRM and monitors the implementation and effectiveness of the decisions taken by the MRC. He also coordinates the internal quality audits and represents Globe Hi-Fabs with all external organizations on matters relating to the quality systems.
QUALITY MANUAL PROCESS FLOW
Doc. No. : AMV/QM/01 Revision No. : 00 Annex. : C Page : 1 of 1 DATE : -
PROCESS FLOW CHART

Concept Dental Care Centre Reception Registration of patient Discussions with patient and Examination Work Diagnosis Cost Estimate of Treatment X Rays & Corrections, if any Final Diagonisist Dental Treatment
Feed Back from patient for Continual Improvement

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QUALITY MANUAL
MANAGEMENT RESPONSIBILITY
DATE : -
5.1 Management Commitment : Top management is committed to the development and implementation of the quality management system and continually improve its effectiveness by: a) The organisation focus is on the satisfaction of the Patients and all its efforts are directed towards it. All members of the organisation are briefed about this and are constantly reminded during training or briefing that in the current competitive market, the importance is to have Satisfied Patients Management believes that this can be achieved if the products are of quality and meets the statutory & regulatory requirement, if any. b) The management has established a Quality Policy and displayed at prominent places within the organisation, which is adhered to achieve the goal. (See Section 3). c) Quality Objectives of the company are established at relevant functional level and are reviewed during MRM for its effectiveness. d) Conducting management review meetings. e) Management realises the fact that to achieve the organisational goal and objectives, adequate resources, physical and human, in all respects have to be provided. Suitable machines, associated equipment, trained personnel, conducive work environment, provision of adequate time in meeting the required service schedule and associated facilities are provided as identified till date, for delivering the quality service. Adequacy of resources is reviewed during management review meetings. References: 5.2 Patient Focus : The management appreciates and analyses the Patient requirements during its market survey, discussion with Patients, Patients feedback, technological enhancement and the range of product available in the market. Management believes in the determination of the Patient requirement and ensures that these are fulfilled with the aim of enhancing Patient satisfaction. References : FM - 206 FM - 111 5.3 Quality Policy : Top management ensure that the quality policy is established and every one works towards achieving it. (refer Section 3.0 ) 1. Quality policy is appropriate to the purpose of the organisational activities. 2. The quality policy includes the commitment to comply with the requirements and continually improve the effectiveness of the QMS. 3. The stated quality policy provides a framework for formulating quality objectives based upon which the management has defined objectives,
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QUALITY MANUAL
MANAGEMENT RESPONSIBILITY
Revision No. : 00 Section : 5 Page : 2 of 4 DATE : -
Which are reviewed during management review meeting. 4. The quality policy is displayed at prominent places and is explained to all employees. It is ensured that all employees directly related with the quality of service understand the policy. 5. The quality policy is reviewed during MRM for its continual suitability. 5.4 Planning 5.4.1 Quality Objectives Top management ensures following quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the organisation. These objectives are measurable to the extent possible and consistent with the quality policy. These objectives are reviewed during MRM and can be modified both in terms of targets and new features to meet the dynamic needs of the organisation. A To increase Community Service by 10 percent annually B Strive for improvement of Patient Satisfaction Level C To identify Wastages in different processes and initiate measures to reduce the wastages D Timely Treatment as per stated Patient requirements E To identify New Vendors and Suppliers for competent Price and Quality and add at least one vendor per month in Approved Supplier List F To protect and Safe guard Patient Property if any by stringent instructions Reference:- Quality Objectives Monitoring 5.4.2 Quality Management System Planning Top management ensures proper planning of the system to deliver the required service quality to the Patients. (a) The comprehensive planning of the complete quality management system is carried out in order to meet the quality objectives and the requirements of the product leading to satisfied Patients. The management is committed to take all necessary steps to maintain the integrity of the quality management system whenever changes to the QMS are planned and implemented. Overall Quality management System planning is being carried out iaw the identified processes and provides reference to various documents, records and objectives. 5.5 Responsibility, Authority & Communication 5.5.1 Responsibility and Authority: For effective Quality management, the Top Management has defined the authorities and responsibilities of all key personnel which have an effect on product / service quality This information is communicated to the respective personnel and at any time they can refer to it in this Quality Manual.
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QUALITY MANUAL MANAGEMENT RESPONSIBILITY
Doc. No. : AMV/QM/01 Revision No. : 00 Section : 5 Page : 3 of 4 DATE : -
5.5.2 Management Representative : Mr has been appointed as Management Representative by the PROPRIETOR, from its own team, who, irrespective of other responsibilities, is responsible and authorized for following : a. To establish, implement and maintain the processes of Quality Management System as per the requirements of ISO 9001 : 2008. b. To report to top management on the performance of the Quality Management System and also on any need for Improvement for review. c. Ensuring the promotion of awareness of Patient requirements throughout the Organization by sharing the information among the employees and d. To liaison with external parties on matters relating to Quality Management System, as deemed necessary. Note: Top Management Member should be deputed as MR 5.5.3 Internal Communication : The top management ensures that appropriate and effective communication processes are established within the organisation and that communication takes place regarding the effectiveness of the QMS and day to day working. There are regular meetings of departmental heads to share the information and collectively perform the work. The quality requirements, objectives, targets, achievements etc. are communicated to all relevant personnel. Tools for communication are team briefings, review meetings, communication through paper & phone, planning schedule etc. 5.6 MANAGEMENT REVIEW Top Management reviews the implementation of Quality Management System, at least once in six month to ensure its continuing suitability, adequacy and effectiveness in satisfying the requirements of ISO 9001 : 2008. The review also includes assessing opportunities for improvement and the need for changes to the QMS, including the quality policy and quality objectives. For this purpose a Management Committee consisting of CEO, General Manager and M. R. is formed. Records from management review are maintained. Management reviews form the basis for quality improvement at all levels of the organisation. This also acts as a platform for continuous improvement in the quality to achieve better Patient satisfaction. 5.6.1 General
QUALITY MANUAL MANAGEMENT RESPONSIBILITY
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5.6.2 Review Inputs: The inputs for the management review typically include the current performance and opportunities for improvements on the following : Follow up Action from previous reviews. Result of Audit reports. Patient feedback. Process performance and product conformity. Status of Preventive and Corrective Actions. Planned changes that could affect Quality Management System such as issues related to Quality Policy and Objectives, Technological Up-gradation, Training needs, Resource profiles etc. Continued suitability and effectiveness of Quality System Recommendation for improvement. Any other issue. 5.6.3 Review outputs: The outputs from the Management Reviews typically include actions relating to : a. Improvement of the effectiveness of the Quality Management System and its processes. b. Improvement of product related to the Patient requirements. c. Resources requirements / needs. The proceedings of the Management Review meetings are recorded in the form of Minutes. 5.7 REFERENCE DOCUMENTS :
Procedure for Management Review
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QUALITY MANUAL
QMS PLANNING
Annex : G DATE : -
Page : 1 of 1
QUALITY MANAGEMENT SYSTEM PLANNING S. No. 1. 3. 5. 6. 7. Process marketing Purchasing Store Internal Audit MRM
ISO Clause No. QM Reference QM Section 7.2 QM Section 7.4 QM Section 7.5 QM/01 Section 8.2 QM Section 5 Other Document Reference SP007 SP 009
Responsibility
MR
7.2 7.4 7.5.5 8.2.2 5.6
SP 015,SP016
SP017 SP001
Purchase Incharge Store Supervisor M.R. M.R.
Doc. No. : AMV /QM/01 QUALITY MANUAL RESOURCE MANAGEMENT Revision No. : 00 Section : 6 DATE : -
Page : 1 of 2
6.1 Provision of resources: The management determines from time to time during MRM and other occasions and provides the resources needed to meet the Patient requirements and deliver the required services. (a) The organisation is committed to implement and maintain the quality management system and continually improve its effectiveness. (b) The management analyses the Patient feedback and forms and uses its result for development in the product quality, which results into improving the Patients satisfaction level. For present capacity of providing services as per List of services existing workspace, building and other resources i.e. machines and associated equipment, trained personnel, process control equipment are found to be sufficient and provided to deliver required service quality and meeting Patient requirements. 6.2 Human Resources: 6.2.1 General : Every person working in the organisation is qualified, experienced, skilled, trained and competent enough to perform the activities entrusted on him. The in house training is also provided to all employees to enhance their competency to perform the work more efficiently. 6.2.2 Competence, Awareness and Training : To identify the training needs of employees and ensuring that all employees undergo appropriate induction on job and skill enhancement training. The product quality is built up / engraved at every stage of operation thus giving importance of need to have skilled and competent persons performing the job. The training is conducted within the organisation and / or arranged with outside agencies. (a) M.R. / CEO Identifies the basic competency / criteria required for personnel performing the job / work affecting product / service quality. [Refer : Competency Requirement AMV /ML/10 ] (b) MR / Respective H.O.D. identifies the nature of training to be given to the individual and accordingly plan the training. Besides this, whenever needed, a session for imparting the requisite knowledge is arranged. (c) MR / Trainer evaluate the knowledge / effectiveness of the training imparted mainly by conducting written test / asking question / through performance etc. and review the results. This also evaluates the competency of the person.
QUALITY MANUAL RESOURCE MANAGEMENT
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(d)
Determination of training requirement depends on the competency analysis as well due to following: To respond quickly to new developments, new skills and learning requirements. On the basis of changes in technology, process, system and person. Effectiveness of training is evaluated and employees training records are reviewed to determine future requirements. (e) Appropriate records of education, training, skills and experience of the employees are maintained.
6.0 REFERENCE DOCUMENTS : (a) Procedure for Control of Documents (b) Training Plan (c) Competency Gap (d) Training Effectiveness (e) Employee Training History 6.3 Infrastructure : The management has determined, provided and maintains the infrastructure needed to achieve the conformity of the product requirements. a. Existing Buildings, Workspace and associated Utilities are conducive to the requirements of the processes for the required plant capacity. b. Testing equipment both in terms of hardware and software are appropriate to deliver the required quality. They are regularly maintained as per recommendation of manufacturer through AMC and calibration, the records of which are kept. c. All supporting services like transport, communication, liason with Govt. agencies etc critical for implanting quality in the product / service are taken care of. d. All supporting services like Transport, Communication Information Systems have been included under the preview of ISO 9001:2008 QMS References a Master List of Machinery and Equipment b Break Down Register c Preventive Maintenance 6.4 Work Environment : The management has provided the work environment conducive to achieve conformity of product / service requirements. The work area is proper lighted, provided with first aid, safety equipment & necessary communication means and regularly cleaned. Physical Environmental Factors like Weather, Lighting, Sound Temperature etc have been taken care of.
QUALITY MANUAL PRODUCT REALIZATION
Doc. No. : AMV/QM/01 Revision No. : 00 Section : 7.1 Page : 1 of 1 DATE : -
7.1 PLANNING OF PRODUCT REALIZATION: Product (Service) realization is that sequence of processes and sub-processes required for meeting the product / service requirements. The organization prepares Project Plans that describe, how the processes of quality management system are applied. Management has planned and developed the processes needed for product realization. All processes are consistent with the requirements of QMS including the following, as appropriate : a) The specifications, features and functional requirements of the service to be delivered are integrated to serve the purpose of service requirement. b) Documentation of the details of the processes; resource requirement in terms of material, machine, manpower etc. c) The relevant national & international specifications and regulatory specifications are used for delivering the required service of the Structural Designs of various projects. d) The records of appropriate inspection at intermediate stages of service and final inspections are recorded. These records are analysed to give feedback for continuous improvement. The Organization determines product realization processes & acceptance criteria, as appropriate, through Project Plans, Work instruction, specification, Patient requirements etc. REFERENCE Project plans, Work Instructions, and Specifications etc.
QUALITY MANUAL PATIENT RELATED PROCESSES
7.2.1 Determination of requirement related to the product / service The management determines the Patient requirements and ensures that : All Enquirys and Tender requirements are carefully studied, before quoting, to identify that all requirements specified by the Patient are adequately defined and there is no requirement which is beyond companys capability in terms of capability, specifications, service requirements, delivery schedule, post deliveries activities etc. b. Any requirement that is necessary for to deliver the required service but not stated / specified by the Patient, is clarified and agreed with. c. All statutory and regulatory requirements related to the product / service is incorporated in the project plans / specification for delivering the required service. e. If there is any additional requirement / information required and decided by the Organization related to the service to execute the order but not stated by the Patient, it is clarified, agreed and incorporated prior to delivery.
a.
7.2.2 Review of Requirements related to product / service During review of contracts prior to giving offer or quotations / acceptance of order / change in contract or order ensures that : a. Product / service requirements are adequately defined. b. The deviations and clarifications for execution of order / contract, if any, are resolved. c. The organisation has the ability, capability and capacity to meet the requirements of the order / contract. d. The records of order / contract review are documented and appropriately maintained. e. Where the Patient does not provide any documented statement of requirements, the Patient requirements are confirmed before acceptance through telephone / fax / Patient visit, as appropriate. f. Whenever the product / service requirements are changed or modified in the order / contract, the relevant documents are amended and the concerned personnel are informed. The results of the review and subsequent follow-up actions are recorded and maintained in the respective project files. Reference: FM 206 Contact Review
QUALITY MANUAL PATIENT RELATED PROCESSES
7.2.3 Patient Communication The management has a well established system of communication with the Patients i.e. telephone, fax, internet, personal visits to Patients, correspondence through letters etc. The field staff interacts with the Patients personally, letters etc. to ensure that : a. The current product information is available. The enquiries are properly addressed and answered in time and follow up is made for its maturing. The contracts or orders received are acknowledged / confirmed and in case of any amendments they are discussed and clarified with the Patients. c. The Patient Feedback is taken from the Patients and the feedback is reviewed. Company also tries to get the Patient feedback through telephonic discussion and records the same for improvements. d. The Patient complaints are recorded and promptly attended.
b.
REFERENCE: Patient Order files, Correspondence, Tender documents Patient Interaction Procedure Patient Satisfaction Patient Complaint Register
Doc. No. : AMV/QM/01 Concept Dental Revision No. : 00 Care Centre Section : 7.3 Page : 1 of 2 DATE : Company is carrying out Design and Development activities mainly for the design of Storage Tank, the hydraulic and Pneumatic System, It does not involve design of Vehicles on which storage tank is mounted
QUALITY MANUAL DESIGN AND DEVELOPMENT
The Works Manager is mainly responsible for implementation of this process. 7.3.1 Design and development planning : Planning for each project is carried out which includes following , as applicable: (a) The preparation of Work Schedules indicating start and end of each activity. (b) Manning schedule with qualification and experience and defining responsibilities & authorities of each with regard to the project. (c) Work schedule is updated suitably as the work progresses. Monitoring of progress is also done through Documentation Submission Schedule / Report internally as well as with the Patient. (d) The review, verification and validation exercise at the appropriate stages is planned and recorded. This is to ensure that the required quality is achieved. Wherever necessary the review, verification and validation are carried out with the Patient also. (e) Organizational and technical interfaces are carried out to ensure effective communication and clear assignment of responsibilities. 7.3.2 Design and development inputs : The inputs relating to product /service requirements are defined and recorded, as appropriate, which are necessary for product design & development. It includes : a. The functional and performance requirements and features are recorded, as given by Patient or contract document. b. Applicable statutory and regulatory requirements are identified. c. Where applicable and available, information derived from previous similar designs are referred. d. Other requirements essential as identified by the organisation for development of the product, which may include following as applicable 1. Patient drawing and related input. 2. Collection of details from field. 3. Results of Investigation, if any. 4. Minutes of meeting 5. Secondary data 6. Any other data / information as per project requirement etc. The above inputs are reviewed for adequacy. Incomplete, ambiguous or conflicting requirements are resolved. 7.3.3 Design and development outputs : Design outputs are documented, as appropriate, in terms that can be verified & validated against the input requirements, includes following, as applicable: How it meets the input requirements for design and development. b. Provide appropriate information through Drawing, material specification, reports etc. for purchasing, execution, etc.
Globe Hi Fabs
QUALITY MANUAL DESIGN AND DEVELOPMENT
Doc. No. : CG/QM/01 Revision No. : 00 Section : 7.3 Page : 2 of 2 DATE : -
Provision of acceptance criteria at various stages of execution in drawing, instruction, reports etc. d. All characteristics that are critical for the safety and proper use / functioning are identified and recorded. e. Appropriate authority before release reviews the design output documents. 7.3.4 Design and development review : At suitable stages, (as per Work Schedule ) systematic review of development is carried out with the concerned functions for the purpose of : A. To evaluate the ability of the results of development to fulfil specified requirements B. To identify any problems and propose necessary actions. The results of the reviews and subsequent follow-up actions are recorded & maintained in the respective project file. Participants in such a review include representatives of the functions internal & external concerned with the development stages being reviewed. 7.3.5 Design and development verification : At appropriate stages, as planned, the design verification is performed to ensure and check the output meets the design requirements. Design verification may typically include : 1. Alternate calculations, 2. Comparison with proven design, 3. Comparison & analysis with secondary data, 4. Internal verification of design by Group , 5. Approval by Patient and 6. Any other as identified. Design verification results and any necessary action as a result of review are recorded & maintained in the respective project file. 7.3.6 Design and development validation : With the scope of design activities as defined in this section, it is impractical to perform full validation of the design by the company. Approval by the Patient is considered to be validation of the design. Where applicable, partial validation is performed on site with Patient and record maintained to the extent applicable. The result of validation i.e. Patient approval for design and subsequent follow up action are recorded & maintained in the respective project file. 7.3.7 Control of design and development changes : Design and development changes are identified, reviewed, documented and controlled. It includes evaluation of the effect of the changes on constituent parts and delivered product. The changes are verified as appropriate and approved before implementation. The result of the review of changes and subsequent follow up actions are recorded & maintained in the respective project file. REFERENCE : A Work Schedule, Documentation Submission Schedule / Reports, Patient approval, Design review records, Design verification & validation records, Drawings, Technical data etc. B Design and Development procedure SP008 C FM 305 Design & Development D FM 206 Contract Review
c.
QUALITY MANUAL PURCHASING
7.4.1 Purchasing Process: The organisation ensures that purchased product confirm to specified purchase requirements. (a) Type and extent of control depends upon : Type of material and its availability. Its impact on product quality. (b) As far as possible materials and services are procured only from approved supplier or approved brand. (c) The organisation evaluates and selects suppliers based on their ability to supply material in accordance with the organizations requirements. Criteria for selection and evaluation is one or more of the following : Evaluation of sample. Having a quality system approved by a recognized body to an appropriate standard. Technical competency of the personnel of the supplier, as appropriate. Having a reputed brand name. (d) Suppliers, from whom routine supplies are procured, are only monitored against quality. Suppliers of one-time purchases are evaluated at the time of placing orders. The feedback of the discrepancies is sent to them for improvements. (e) Records of the results of evaluations and any necessary action arising from the evaluation are maintained. 7.4.2 Purchasing Information: Approved suppliers data, detailing material / product / service they provide and criteria of their selection is maintained. Company places the purchase orders for the items, which are required to meet service-delivering requirement. Purchasing document contain information describing the product to be purchased, including where appropriate : a. Requirement for approval of product, procedures, processes, and equipment. b. Requirement for Qualification of personnel. b. Quality management system requirements. c. Prior to release, the purchase orders are reviewed and approved for, including, as applicable.
QUALITY MANUAL
PURCHASING
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d. Whenever required amendments to purchase orders are issued with the consent of the supplier and the same is informed to all concerned. e. In case of repeat orders to a supplier, a telephonic order can be placed and record kept. The organization ensures the adequacy of specified purchase requirements contained in the purchasing documents, prior to their communication to the supplier. 7.4.3 Verification of Purchased Product: (a) The inspection of materials is carried out as per the specifications. (b) The respective indentor performs the in-coming inspection on all critical / important material as per the requirements and only accepted material is retained. (c) Purchase order may include provision for companys verification and method of release of purchased material / item from suppliers premises. (d) Where the company verifies purchased material at suppliers premises, the company specifies verification arrangements and the method of its acceptance. (e) Where specified in contract, purchase order includes provision for Patient access to verify material conformance at the suppliers premises. REFERENCES List of Approved Suppliers Supplier Selection Supplier Evaluation
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QUALITY MANUAL
PRODUTION & SERVICE PROVISION
DATE : -
7.5.1 Control of production and service provision : All processes are planned before execution to ensure conformance of the services to the specified requirements. Controlled conditions include, as applicable : (a) The information / specifications that describe the characteristics of the service and the specifications to deliver required service are available. (b) Work instructions, where the absence of such documents could adversely affect, are documented and followed. (c) Appropriate equipment / machines have been identified and provided for services to ensure required quality in the service. These are suitably maintained through annual maintenance contract, wherever applicable, and records are kept. (d) The necessary monitoring and measurement devices are available at the place of work. (e) The Service parameters are monitored and recorded wherever necessary. The inspection results are recorded and analysed against the specification and results are reported to the concern authority. (f) Inspection are performed in accordance with procedures / Project Plans, Specifications, drawings. (g) Final verification / release of the drawing or dispatch, ensures that all specified inspections & requirements have been completed as per documented procedures and that the service meets specified requirements. (h) Safety norms are available at the place of work. (i) The Design and drawing are sent to the Patient by suitable means so as it reaches him safely and timely. 7.5.2 Validation of processes for production and service provision : The organization validates welding and Painting processes for service provisions where the resulting output cannot be verified by subsequence monitoring measurement. This includes processes where deficiencies may become apparent only after the service is put to use. Such validation is carried out, to demonstrate the ability of the processes to achieve the planned results. Procedure Qualification Record Work Instructions 7.5.3 Identification and Traceability : (a) All materials / intermediate service / work in progress are identifiable, where appropriate, through initial stages up to the point of delivery by one or more of the following means : Visual recognition. Separate area / location marked for keeping the particular type of material / sample required for service.
QUALITY MANUAL
CONCEPT DENTAL CARE CENTRE
PRODUCTION & SERVICE PROVISION
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(b) The implementation of system ensures that required monitoring of process, inspection and tests are performed. The identification of service status is maintained throughout service cycle, through suitable means on the project files, drawings etc. This identification enables the delivery of only conforming service. Means used for identification of status is one of the following : Separate physical specified location / Identification label / marking. (c) Traceability is not a requirement for the but for traceability of the internal process output unique number for drawings with regard to project is allotted. REFERENCE DOCUMENTS :
7.5.4 Patient Property : (a) The organisation exercises utmost care with Patient property including intellectual, while it is under the organisations control or being used by the organisation. (b) Whenever received, the Patient property is : Verified whether it meets the specification for its use. Properly marked to maintain its identification. Properly stored to avoid any damage during storage. (c) Is any Patient property is lost, damaged or otherwise found to be unsuitable for use are reported to the Patient for necessary action so as to meet the order conditions. The records are maintained. (d) In case of any discrepancies or deviation in the Patient property quality, the Patient is intimated for necessary action. 7.5.5 Preservation of Product : The organisation maintains and follows all necessary procedures to ensure that the products / material used to deliver the service are properly handled during sampling, testing and storage so as its quality is maintained.
(a) IDENTIFICATION
Products are suitably identified.
QUALITY MANUAL PRODUCTION & SERVICE PROVISION
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(b) HANDLING
Precautions are taken at all stages to protect materials, samples from damage during handling. All events of abnormal damage to the materials due to handling are investigated and proper corrective & preventive actions are taken.
(c)PACKAGING
Protect reports from loss or damage Meet Patient requirements. Meet all legislative requirements, wherever applicable.
(d) STORAGE
Materials are stored so as to prevent damage or deterioration, pending
use or delivery. Periodic verifications are carried out (atleast once a year) wherever applicable to see the condition of samples / materials in storage to detect any damage and / or shelf life being exceeded. Storage conditions are maintained to ensure that quality of samples / materials is maintained, wherever applicable.
(e) PRESERVATION / PROTECTION

Whenever required proper preservation / protection conditions are maintained so as to prevent any effect during execution of the service required.
QUALITY MANUAL
MEASUREMENT, ANALYSIS & IMPROVEMENT
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7.4.
Control of monitoring and measuring devices
Company determines the monitoring and measurements to be undertaken and the monitoring & measuring devices needed. A list of monitoring and measuring devices is maintained . An annual calibration plan is prepared according to the frequency of calibration of various devices. The equipments are calibrated according to calibration plan against measurement standards which are traceable to national or international standards. Where no such standards exist, the basis for calibration or verification is recorded.
The calibrated instruments are marked green and status of monitoring and measuring equipment, which indicates control no., calibration date and next due date in recorded in file.. The equipments are protected from damage and deterioration during handling, maintenance and storage and are safeguarded from adjustments from unauthorized personnel. When a device is found to be out of calibration, its previously measures results are verified for validity. Such device is discarded and marked red to prevent its further use.
General : The organisation has planned and implemented the monitoring, measurement and analysis systems for continual improvement in all processes of service realisation. and the national & international standard. The observations and results are recorded and maintained. (b) The management by means of conducting Internal audits, review meetings, feedbacks etc. is able to feel the effectiveness of the QMS adopted and implemented. Whenever, there is a need to put more concentration for improving its effectiveness in a particular area / department an appropriate action is initiated and monitored. (c) The management is committed to continually improve the effectiveness of the quality management system by adhering to the quality policy and objectives currently in practice. (d) The statistical techniques like cause & effect diagram, trends, histogram, graphs are used for improving the system effectiveness and analysis of the objectives to be achieved. Reference : AMV QA 03 Caliberation Plan 8.2 Monitoring and Measurement : 8.2.1 Patient Satisfaction : As one of the measurements of the performance of the quality management system, the organisation monitors information relating to Patient satisfaction as well the perception as to whether the organisation has fulfilled the Patient requirements. MR is responsible for getting Patient feedback through feedback form, which is recorded and discussed in Management Review Meetings, and analysed to further improve the QMS and enhance the Patient satisfaction level. The analysis based on above highlight the general satisfaction level of the Patients with respect to the service and organisations working. Reference: FM 109 Patient Survey
(a) The service specifications are derived from the requirements of the Patient
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QUALITY MANUAL
MONITORING AND MEASUREMENT
8.2.2 Internal Audit : The organisation has developed and maintained a program for the periodic internal audit at planned intervals to determine effectiveness of the quality management system. Audits are undertaken as a means of determining how effectively the quality systems are implemented and maintained. (a) To verify the effectiveness and compliance to the planned arrangements of the requirements of this international standard and to the documented quality management system. (b) An audit plan is prepared based on the status and importance of the processes & area to be audited, and previous audit results. (c) Audit is carried out as per plan. (d) All areas of the Organisation are to be audited in each unit with respect to the requirements of the international standard. (ISO9001:2008) (e) The frequency of the audit is Once in six Month, which may be further reduced or increased based on the status and Importance of the activity. (f) Trained personnel, who are independent of those having direct responsibility for the activity being audited, carry out audits. IQA can also be conducted by an external agency. (g) The HOD responsible for the area being audited Audit findings, as recorded, are used as the main formal means of resolving problems and deficiencies of the QMS and reported in Management Review Meetings. (h) Audit findings are brought to the attention of the HOD responsible for the area audited, who undertakes timely action, as appropriate and ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes. (i) Follow up audit is carried out to verify the corrective action and its effectiveness and the reporting of verification results. (j) Records of all internal audits are maintained. (k) A documented procedure is established which gives the responsibilities and requirements for planning and conducting audits, and reporting of results and records. (l) NOTE: The Management understands its responsibility to preserve Internal Audit records for future reference. REFERENCE DOCUMENTS Procedure for Internal Auditing Internal Audit Plan & AMV 15 Non Conformance Report Internal Audit Summary 8.2.3 Monitoring and Measurement of Processes : The Organization applies suitable methods for monitoring and, where applicable, measurement of QMS processes. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, appropriate correction & corrective action are taken to ensure conformity of the service.
QUALITY MANUAL
MONITORING AND MEASUREMENT
8.2.4 Monitoring and Measurement of Product : The Organization monitors and measures the characteristic of the service requirement, to verify that service requirements are fulfilled. This is carried out at appropriate stages of the product / service realization process in accordance with the planned process flow chart or project plans. Evidence of conformity with the acceptance criteria is maintained for the critical raw material, in-process and final inspection. The final inspection records (approval of drawing etc.) indicate the person authorizing release of product for dispatch. Service delivery do not proceed until all the planned arrangement have been satisfactorily completed, unless otherwise approved by the relevant authority i.e. Proprietor and where applicable by the Patient. References Training Evaluation Patient Surveys Assessment Patient Satisfaction
QUALITY MANUAL
CONTROL OF NON CONFORMING PRODUCTS
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8.3 Control of Non-Conforming product : The Organization ensures that product which does not confirm to the requirements are identified and controlled to prevent unintended use or delivery. The organization deals with nonconforming products in one or more of the ways as given in following procedure : (a) Non conforming intermediate services are reviewed and disposed by way of Rework / reprocess (b) CEO takes the decision and authorizes its use, release or reprocessing and, where applicable, by the Patient. (c) By taking action to preclude its original intended use or application for raw material, wherever applicable. (d) Non conforming services are identified, held and prevented from dispatch. (e) Adequate records are maintained, wherever possible, to provide objective evidence that retesting is satisfactorily completed and that re-inspection has been carried out. (f) When nonconformity of the service delivered is reported after delivery, the organisation takes appropriate action for correction and / or initiates a preventive action to avoid its recurrence.
(g) The control and related responsibilities and authorities for dealing with non-conformance product / service are defined in a documented procedure
QUALITY MANUAL
ANALYSIS OF DATA
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8.4 Analysis of data : The Organization determines, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the Quality Management System and evaluates it where continual improvements of the Quality Management System can be made. This includes data generated as a result of monitoring & measurement and from other relevant sources. These datas are analyzed to provide information on : a. Patient satisfaction level using Patient feedback form. b. Conformance to product requirements analysis of final reports. c. Characteristics and trends of processes and products including opportunities for preventive action and d. Inspection of incoming material gives the suppliers performance status. f. The data generated are currently analysed for observing the trends. This information is used for control of rejections and the identification of the area, which need attention. As the system matures other statistical techniques will be adopted as appropriate and useful for the organisational growth. g. REFERENCE : Patient Feed Backs
8.5.1 Continual Improvement: The organization plans and manages the processes necessary for the continual improvement of the effectiveness of Quality Management System and facilitates the continual improvement of Quality Management System through the use of Quality Policy, Quality Objectives, Audit results, Analysis of data, corrective and preventive actions and Management Review. 8.5.2 Corrective Action: The organization takes actions to repair the defect observed, which has caused the non-conformity in order to prevent recurrence. Corrective actions are appropriate to the effect of non-conformities encountered. The documented procedure for corrective action details the requirements for :
a. Reviewing of product non-conformities and Patient complaints.
b. Determining and analysing of causes of non-conformities relating to product, process and quality system and recording of the result. c. Evaluating the need for actions to ensure that non-conformities do not recur. d. Determining and implementing the action needed to eliminate the causes for NC. e. Recording results of action taken. f. The corrective actions taken are reviewed in Management Review Meetings.
QUALITY MANUAL
IMPROVEMENT
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8.5.3 Preventive Action: The organization determines action needed to eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive actions taken are appropriate to the effect of the potential problems. The documented procedure for preventive action details requirements for :
a. Determining
and analysing of potential non-conformities based on information from production, processes, product quality reports, concessions, audit reports and Patient complaints and their causes.
b. Evaluating the need for action, to prevent occurrence of non-conformities. c. Determining and implementing preventive action needed. d. Recording results of action taken. e. The preventive actions taken are reviewed in Management Review Meetings.

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Concept Dental Care Centre

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7.0 7.1 7.2 7.3 7.4

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Production and Service provision

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Feed Back from patient for Continual Improvement

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