QUALITY MANAGEMENT SYSTEM MANUAL

As Per ISO 9001:2000 DOC NO.:-VNKH/QMSM/01

Edition No-01 Revision No-00 Issue No-01 Dated 05/08/07

VINAYAK HOSPITAL. (A Unit of Chaudhary Nursing Home Pvt. Ltd.) NH-1, Sector-27 Atta, Noida 201301, (U.P.) INDIA
Helpline: 95120-2444222,2444333 PH:-+91-120-2541337-38-39, FAX: +91-120-2544801, E-Mail: info@ hospital.com

This Quality Management Manual is the sole property of M/s. VINAYAK HOSPITAL. and should not be copied or reproduced without the permission of the CCMD.

VINAYAK HOSPITAL.
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QUALITY MANAGEMENT SYSTEM MANUAL

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1. TITLE OF DOCUMENT 2. EDITION NUMBER 3. COPY SUBMITTED TO 4. STATUS 5. COPY NUMBER

QUALITY MANAGEMENT MANUAL

01

CONTROLLED

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QUALITY MANAGEMENT SYSTEM MANUAL

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The purpose of the Quality manual is to give an overview as to the methodology adopted by VINAYAK HOSPITAL. to follow / comply with the requirements of all the of ISO 9001 : 2000 The Quality system has been deployed to ensure that All activities affecting quality are identified, defined and documented. Services conform to the specified requirements. Deployed systems in the company meets all requirements of ISO 9001:2000 To built the Customer confidence in the term of reliability of Service.

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Rev No

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Description of changes

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Signature of copy holder & Date

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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 0.5 TITLE: Scope and Approval

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Quality Manual Structure

The Quality Management System is structured as per the requirements of standard ISO 9001-2000 through chapters 4.0 to 8.0 which are in line with the technical requirements of the Services, for suitable quality achievement.

Scope
The Quality Management System covers all aspects and facts of HEALTH CARE AT PAR WITH INTERNATIONAL STANDARD AT AFFORDABLE COST IN THE FIEIDS OF ADVANCED MEDICAL AND SURGICAL CARE AS WELL AS SPECIALTY SUPPORTS.

Quality Management System

The Quality Management System is derived from the Quality Policy and objectives given in this manual, and is customer- focused & aimed at enhancing customer satisfaction and gaining an acceptance of the in the market. It uses the process approach, systematic identification and management of activities / processes that are employed through, a sequential process of As documented in manual

Approval
The Management approves this Quality Manual and is committed, To meet and exceed customer requirements & expectations. To practice the QMS in all sphere of working of the company and thus to serve Customers with great & prompt responsiveness 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.

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DOC.NO:VNKH/QMSM/01 ISO-9001:2000 PAGE :-1 of 3 SECTION

QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 1.0 TITLE: Table of Contents

QUALITY MANUAL No. of Pages

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0.1 0.2 0.3 0.4 0.5 1.0 2.0 2.1 2.2 3.0 4.0 4.1 4.2.1 4.2.2 4.2.3/4 Annex. I Annex. II Annex. III 5.0 5.1 5.2 5.3 5.4.1 5.4.2 5.5 5.5.1 5.5.2 5.5.3 5.6 5.6.1 5.6.2 5.6.3

Preface Document change record Revision record Sheet Scope and approval Table of Contents Introduction of company Distribution Application & Abbreviation Quality Policy & Objectives Quality Management System General Requirements Documentation Required-general Quality Manual Control of documents/ Quality Records Responsibility and Authority Organisation Chart Process Flow Chart Management Responsibility Management Commitment Customer Focus Quality Policy Planning / Quality Objectives Q M S Planning Responsibility , Authority & Communication Responsibility and Authority Management Representative Internal Communication Management Review General Review Input Review Output
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DOC.NO:VNKH/QMSM/01 ISO-9001:2000 PAGE :- 2 of 3 SECTION 6.0 6.1 6.2 6.2.1 6.2.2 6.3 6.4 7.0 7.1 7.2 7.2.1 7.2.2 7.2.3 7.3 7.4 7.4.1 7.4. 2 7.4.3 7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6 8.0 8.1 8.2 8.2.1 8.2.2 8.2.3 8.2.4

QUALITY MANAEMENT SYSTEM MANUAL SECTION:- 1.0 TITLE: Table of Contents

QUALITY MANUAL No. of Pages 1

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Resource Management Provision of Resources Human Resources General Competence, Awareness & Training Infrastructure Work Environment Realisation of Service Planning of Service Realisation Customer related processes Determination of requirements related to Service Review of Requirements related to Service Customer Communication Design and Development (N/A) Purchasing Purchasing Process

Purchasing Information Verification of Purchased Service Services Control of Services Validation of Process for Services Identification and Traceability Customer Property Preservation of Service Control of Monitoring and Measuring Device Measurement, Analysis and Improvement General Monitoring and Measurement Customer Satisfaction Internal Audit Monitoring and Measurement of Processes Monitoring and Measurement of Service APPROVED BY SIGNATURE DESIGNATION CMD DATE 05/08/07

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DOC.NO:VNKH/QMSM/01 ISO-9001:2000 PAGE :- 1 of 3 SECTION 8.3 8.4 8.5 8.5.1 8.5.2 8.5.3 Annex IV Annex V Annex VI

QUALITY MANAGEMENT SYSTEM MANUAL SECTION:-1.0 TITLE: Table of Contents

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Control of Non-Conforming Service Analysis of Data Improvement Continual Improvement Corrective Action Preventive Action List of Procedures List of Work Instructions List of Records

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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 2.0 TITLE: Introduction of company

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VINAYAK HOSPITAL. situated at NH-1, Sector-27 Atta, Noida-201301 (U.P.) INDIA is engaged in the Service hospital of HEALTH CARE AT PAR WITH INTERNATIONAL STANDARD AT AFFORDABLE COST IN THE FIEIDS OF ADVANCED MEDICAL AND SURGICAL CARE AS WELL AS SPECIALTY SUPPORTS. It started its first hospital on 2002 and since then has been getting regular Service hospital. To ensure this, the hospital appoints dedicated qualified and trained staff for compassionate patient care. Spared over 30,000 sq. feed covered area and 500-bed super-specialty hospital. It is strategically located and is close to the Sector-18 Noida U.P. The building layout has been intelligently designed to ensure smooth flow of visitor traffic and movement within the hospital. There are 2 lifts including a stretcher lift where the patient can be smoothly moved from point to point. The sprawling, centrally air- conditioned building has two powerful generations with combined capacity of 400 kw to ensure seamless supply of power to hospitals. . As per CUSTOMERS REQUIREMENT . Hospitals aims are to achieve high growth rate with new hospital technology that inspires Human achievements and satisfaction through a harmonious environment, knowledge, skills, efforts, new ideas and excellence, all directed to suit the CUSTOMERS SATISFACTION .

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Quality Manual is the apex document that describes the Quality Management System established and implemented by VINAYAK HOSPITAL. to meet the requirements of International Standard ISO 9001: 2000 and to consistently provide Service that meets customer requirements. Quality Management System, which is customer focused, aims to enhance customer satisfaction through the effective application of the system and the processes for its continual improvement and the assurance of conformity to customer requirements. Manual refers supply chain of supplier-Organisation-Customer. This Manual applies to all activities, which contribute to the quality of HEALTH CARE AT PAR

WITH INTERNATIONAL STANDARD AT AFFORDABLE COST IN THE FIEIDS OF ADVANCED MEDICAL AND SURGICAL CARE AS WELL AS SPECIALTY SUPPORTS.
Distribution
1. The Manual, its copies or extract from it, must not be passed on to any person without the written permission of the CMD of the VINAYAK HOSPITAL. 2. Copies marked with reference stamp may be given to Customer / Outside agencies purely for reference purpose. Reference copies are not covered under change control but are current at the time of issue. 3. Management Representative (MR), appointed by the CMD is responsible for establishing and maintaining the processes of the Quality Management System, for periodically reporting to the management on the performance of the system and for promoting awareness of customer requirements through out the organisation. 4. The CONTROLLED copies are covered by change control and are stamped in red on all pages. The controlled copies are distributed to In charge of the concern department. It is the responsibility of CONTROLLED copy holder of this Manual to maintain and incorporate all revision on receipt and keep it up to date.

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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 2.1 TITLE: Application

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APPLICATION
The following requirements of the ISO 9001-2000 neither affect the organizations ability nor absolve it from its responsibility, to provide product that meets customer and applicable regulatory requirements. The exclusions are limited, depending on type of product, customer requirements and applicable regulatory requirements. 1 . Design and Development - Design and Development (7.3), Validation of Processes (7.5.2) not applicable Statutory And regulatory standard, Design activity is excluded in scope of this manual. Definitions as given in ISO 9001-2000. Following supply chain is used

Supplier

Organisation

Customer

The term organisation replaces previously used term supplier (1994 version), Sub contractor is replaced by term supplier, to match vocabulary used in general Process an activity using resources and managed to convert inputs into outputs is considered as a process. Product results of a process; is also means Service.

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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 2.2 TITLE: Abbreviation

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Abbreviation used in Manual SR.NO. ABBREVATION 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 21 22 23 PUR STR Product HPTL Customer MTN DEP MKT REV G.R.R. VNKH QMS CMD HOD NCS CAPA DEV COMM P.O. MR IS QMS Purchase Store

DESCRIPTION

Service (Treatment) Hospital Patient & ward Maintenance Despatch Marketing Revision Good Receipt Register VINAYAK HOSPITAL. Quality Management System Managing Director Head of the department Non Conforming Services Corrective Action Preventive Action Development Commercial Purchase order Management Representative International Standard Quality Management System
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CMD 05/08/07

VINAYAK HOSPITAL.

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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 3.0 TITLE: Quality Policy and Objectives

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QUALITY POLICY

WE VINAYAK HOSPITAL. ARE COMMITTED TO RENDER ADVANCED QUALITY HEALTH CARE TO THE PATIENTS AT AFFORDABLE COST AND TO DEVELOP A SYSTEM WHERE WE COULD UPDATE COUNTINUALLY IMPROVE OUR TECHNOLOGY, INFRA-STRACTURE, AND HUMAN RESOURCES WITH TIME AND COMPLYING WITH APPLICABLE REGULATORY REQUIREMENTS.

CMD Place :NOIDA Dated:05/08/07

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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:-3.0 TITLE: Quality Policy and Objectives

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QUALITY OBJECTIVES

We at VINAYAK HOSPITAL. Shall A) By understanding customers needs and even exceeding their delight.

B) To be the customers choice by providing the best & exceeding in the health care services. C) By maintaining /servicing our machinery and equipment as per calibration/ maintenance schedule. D) To make continues Improvement through Management by Objectives, training and up-gradation programs. E) By monitoring housekeeping, and hygiene as per schedule.

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QUALITY MANAGEMENT SYSTEM PURPOSE. The purpose of this chapter is to provide an overview of the Hospitals Quality Management System and the principles upon which it is built. [ISO 9001:2000] and operated. SCOPE This section applies to the whole of the Hospitals documentation establishment, implementation, maintenance and continual improvement of the quality management system, as well as the preparation of quality plans for all Services manufactured by the company. RESPONSIBILITY The responsibility for implementation review approval and improvement lies with the Management Representative. He is also responsible for periodically reporting to the Management about the performance of the Quality Management System and the need for improvement if any. He shall also ensure the promotion of awareness of customer requirements throughout the organisation. QUALITY MANAGEMENT SYSTEM General Requirements. The company has developed and implemented a documented Quality Management System to meet the requirements of ISO 9001:2000 standards. The Quality Management System, is implemented by : Processes are identified throughout the organisation including those for management activities, resources, Service realisation and measurement needed for the QMS (Refer Process flow Diagram Annex-III) The sequence and interaction of these processes are determined. The criteria and methods required to ensure the effective operation and control of these processes are suitably determined (ref; Quality Plans) Availability / Requirement resources and information necessary to support the operation and monitoring of these processes is decided by reviewing there work instructions. Measuring, monitoring and analysing these processes.

2.0

3.0

4.1

a)

b) c) d) e)

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f) g) h)

Implementing actions necessary to achieve planned results and continual improvement of these processes. The company plans & manages these processes in accordance with QMS. The Quality Management system also has a provision for controlling any process/s which is/are out source.

4.2.1

Documentation Requirements- General

The Organisation chart and responsibility and authority of the main personnel is defined and documented.(Refer Annexure- IV)

a) b) c) d) e)

The Quality Policy & Quality Objectives provide the basis for QMS ( As stated in chapter 3 ). The Quality Manual which is made, maintained and improvised to deal with all the scope of the QMS, exclusions with justifications The Quality Management System together with the documented procedures as required in ISO 9001-2000 are the main framework of the system. Documented operating procedures as required by the Organisation, such as Quality Plans, Work Instructions etc, Quality records as required by standard ISO 9001-2000 (4.2.4),for effective operation and control of activities/processes The procedures describing the logical sequence of activities with necessary control and responsibility, are established, documented, implemented and maintained. ( Refer Annexure V )

4.2.2

Quality Manual
The Quality Manual,(this Manual) which is established and maintained, details the scope of the QMS, exclusions with justifications & documented procedures or reference to them. It also describes the interaction between the processes of QMS .

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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:-4.0 TITLE: 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 (VNKH/QP/01) is established to cover the following; To approve all documents for adequacy prior to issue. To review, update and re-approve documents. To identify the current revision status of documents. To ensure that relevant version of documents are available at the points of use. To ensure legibility, identifiably & retrievable of the documents. To identify the documents of external origin & control their distribution. To prevent unintended use of obsolete documents and suitably Identify them, if they are retained for any purpose.

4.2.4

Control of Quality Records

A documented procedure, VNKH/QP/01 is established, for the Identification, storage, retrieval, protection, retention-period and disposition of all Quality Records. 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.

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QUALITY MANAGEMENT SYSTEM MANUAL Annexure-I TITLE: Responsibility and Authorities

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CMD
Formulates all decisions and implements them Manages the fund flow for effective functioning of all units Gives the Quality Policy and Objectives of the company. Lay down task and targets for all. Identifying training needs and preparation of training calendar. To create work environment by educating and motivating the employees. To provide infrastructure for implementing quality management system. Interacts with the customer for all matters relating to Service and services. Responsible for Administration, office efficiency & effectiveness Responsible for the effective operations in compliance with corporate policies and objectives. Chairs Management review meetings. Ensure safety requirement are being followed and safety equipment are in order

Training of persons
Control the financial situation of the company. Arrange for supplier Payment In time Procurement of materials conforming to required specification against indent - raised. Arrange for dispatches as per customers schedule and preparation of necessary records required To monitor despatches for supplier for off-loaded work. To monitor all matters related with finance. .

Management Representative
Establishment, Implementation, Documentation and Maintenance of the Quality systems. Planning & Conducting Internal audits. Attend to all customer complaints Identify the training needs of all and carryout training of people . Provide service and technical support to all customers (If required) Evaluating performance of Quality systems & corrective action and preventive action Preparation of agenda for Management Review Meeting. Preparation of Management Review Meeting Schedule. Organising Management Review Meetings and corrective action Preparation of reports for consideration by the meeting. Action on the recommendations of Management Review Meetings. Co-ordination with Certifying body.

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QUALITY MANAGEMENT SYSTEM MANUAL Annexure-I TITLE: Responsibility and Authorities

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Head of Marketing
Preparation and Forwarding of Quotation for enquiries received. Follow up and finalisation of Orders. Co-ordination with customer and staff in the organisation Co-ordination for planning Of Trial / first lot Service. Follow up with customer For results of Trial. Establishing new areas of Service hospital as and when the need arises. Incorporating new Services in to the System and release of all relevant Information / documents to the Concerned dept. Co-ordination and follow with customer for getting the feed back on supplied Service. Taking corrective and preventive action on customer complaints for entire customer satisfaction.

Head of Purchase
Procurement of materials conforming to required specification against indent - raised. Development assessment approval of supplier Review & verification of purchase records Arrange for supplier Payment In time Take appropriate action on suppliers in case of not fulfilling the specified Requirements in the contract. Inform / Discuss Supplier quality rating to the concern and Intimate Q.A for poor quality rating of supplier.

Preparation and verification of GRR Control & monitor of handling / storage Preservation / receipt / issue of materials. Arrange for dispatches as per customers schedule and preparation of necessary records required Issue of materials and collection of bought out off-loaded and raw materials as per requirements To monitor despatches for supplier for off-loaded work.

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QUALITY MANAGEMENT SYSTEM MANUAL Annexure-I TITLE: Responsibility and Authorities Finance

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7.

Incharge

Updating the records of training of all personnel within the organisation in their respective file. Monitoring on Purchase activities. Monitoring on Sales Activities Monitoring on payment of Customer, Supplier. And Bank Transactions. Monitoring on Sales A/c s and Purchase A/cs activities. Monitoring on other commercial activities. Monitoring on Excise formalities and Excise records.

8.

Incharge Stores
Preparation and verification of GRR. Control & monitor of handling / storage Preservation / receipt / Issue of materials. Arrange for dispatches as per customers schedule and preparation of necessary records required. Issue of materials and collection of bought out off-loaded and raw materials as per requirements. To monitor despatches for supplier for off-loaded work. Incharge Commercial Updating the records of training of all personnel within the organisation in their respective file. Monitoring on Purchase activities. Monitoring on Sales Activities Monitoring on payment of Customer, Supplier. And Bank Transactions. Monitoring on Sales A/c s and Purchase A/cs activities. Monitoring on other commercial activities.

Monitoring on Excise formalities and Excise records.

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QUALITY MANAGEMENT SYSTEM MANUAL Annexure- II TITLE: Organisation Chart ORGANISATION CHART CMD

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Director

Chairman of Dept.

Medical Director

GM (ADMN)

G.M. Finance

G.M. Mktg.

DMS

Sr. Mgr.

Sr. Mgr.Fin.

Sr. Mgr. Mkt

NS

Mgr. (Personnel)

A/O

Mgr. Mkt.

DNS

Admin. Mgr.

Mgr.(Fin.)

Mktg. Exe.

ANS

Bio- Medical Engineer H.K. (I)

A/C

Staff Nurses

Transport Incharge

Security Incharge

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QUALITY MANAGEMENT SYSTEM REV MANUAL ANNEXURE- III Sequence & Interactions of Process

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Q.M.S.

AWARNESS TRAINING FOR QUALITY MANAGEMENT SYSTEM

Quality Ploicy / Quality Objectives / Apex Manual / Procedures & Work Instructions to meet requirement

Internal Quality Audit

Continual Improvement

Management Review Meeting

Corrective Action And Preventive Actions

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QUALITY MANAGEMENT SYSTEM MANUAL ANNEXURE- III Sequence & Interactions of Process REISTRATION

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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 5.0 TITLE:-Management Responsibility

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5.1

Management Commitment:
Top managements commitment to the development, implementation and improvement of the Quality Management System is evidenced by:

a b c d e 5.2

Its Communication to all concerned in the organisation, the importance of meeting customer requirements of the Service as well as statutory and regulatory as applicable. Statement / establishing of the Quality Policy Ensuring establishment of Quality Objectives Conducting management review meetings. Ensuring the availability of necessary resources, man power, for all activities.

Customer Focus : ( Refer 7.2.1 and 8.2.1)

Top management of the organisation ensures that customer requirements are determined and are fulfilled with the aim of enhancing Customer satisfaction.

5.3

Quality Policy
The Quality Policy Statement (Section 3.0) defines the Organisations quality policy. Employees are fully briefed about this policy on joining the Organisation and during planned training. All employees are responsible to implement the Quality Policy of the Organisation. The Quality Policy is displayed at prominent places within the Organisation and is controlled.

a b c d e f

Top management, while defining Quality Policy, considers the following; It is appropriate to the purpose of the Organisation. It reflects commitment to meet the requirements, and continually improve the effectiveness of Quality Management System. It has a framework for defining and reviewing of Quality Objectives. It is communicated and understood by all concerned in the Organisation. It is regularly reviewed for continuing suitability.

5.4
5.4.1

Planning

Quality Objectives (7.1a planning of Service realisation)

Management ensures, establishing Quality Objectives at relevant functions and levels within the Organization. These objectives are measurable, and consistent with the quality policy, commitment to continual improvement and also for meeting the requirements of the Services. These objectives are constantly reviewed (5.6.1)

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5.4.2

Quality Management System Planning

The Quality Management System is Planned to meet the requirement of ISO 9001:2000 and also the Quality Objectives defined by the Organisation. The Documented Quality Management System is the result of planning and is in line with the Quality Objective that the Management set. The requirement which the system meant to meet are (4.1 ) :Determination of the process needed for the system and application throughout the organisation. Determination of the sequence and interaction of these processes. Determination of the criteria and method to ensure the effectiveness of the operation and control of the processes. Making available the requisite resources Human as well as physical to support the operation & monitoring of the processes. Monitoring, Measuring and analysing the processes. Initiating actions to achieve planned results and also for continual improvement of the processes. The Management further ensures that the integrity of the QMS is maintained wherever any changes to the system are planned and implemented.

a b c d e f

5.5 5.5.1

Responsibility, Authority & Communication Responsibility and Authority:

Functions, responsibility and authority (Refer Annexure-I) are defined and communicated, to all concerned for effective quality management. 5.5.2 a b c

Management Representative:.
The CMD has appointed Dr. A.K.Chaudhary, the head of Hospital as a Management Representative who is responsible and authorised for following; To establish, implement and maintain the processes of Quality Management System. To report to top management on the performance of the Quality Management System and also on any need for Improvement. To promote awareness of Customer requirements, throughout the Organisation and to liaison with external agencies on matters relating to Quality Management System, as deemed necessary. Internal Communication; Appropriate communication processes regarding Quality Management System & its effectiveness, are established, within the Organisation. Management ensures such communication regarding effectiveness of Quality Management System. APPROVED BY SIGNATURE DESIGNATION DATE CMD 05/08/07 ISSUED BY MR 05/08/07

5.5.3

VINAYAK HOSPITAL.
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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 5.0 TITLE:-Management Responsibility

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5.6 5.6.1

Management Review General

Top Management reviews the implementation of Quality Management System, at planned intervals to ensure its continuing suitability, adequacy and effectiveness. The review covers, evaluation of the need for changes, to this system, Organisations Quality Policy and Quality objectives. For this purpose a Management Committee consisting of CMD, M R, Head Hospital, Head Purchase ,Head, Head Marketing is appointed. Records from management review are maintained.

5.6.2

Review Inputs:
The Review inputs for the management review include the current performance and opportunities for improvements on the following: Follow up Action from previous management reviews. Audit report findings. Customer feedback Process conformance and Service conformity Status of corrective action and preventive action. Review of Quality Management System such as issues related to Quality Policy and Objectives., Technological Up-gradation, Training needs, Resource profiles etc. Suitability and effectiveness of Quality Management System Recommendation for improvement. Resources required

5.6.3
a b c

Review outputs:
The Review outputs from the Management Reviews, include actions relating to: Required Improvement of the effectiveness of the Quality Management System and its processes. Required Improvement of Service related to the customer requirements. Resources requirements/needs. The minute of the Management Review meetings are recorded and extracts circulated to concerned dept. in charge for action by the MR.

APPROVED BY SIGNATURE DESIGNATION CMD

ISSUED BY MR

DATE

05/08/07

05/08/07

VINAYAK HOSPITAL.
DOC.NO:VNKH/QMSM/01 ISO-9001:2000 PAGE :-1 of 1

QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 6.0 TITLE:- Resource Management

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6.0 6.1

Resource Management: Provision of resources:

The Resources required are determined and provided in a timely manner. to implement, maintain and improve the Quality Management System and continually improve its effectiveness and to enhance Customer satisfaction by meeting the customer requirements The Resources covers equipment and accessories, trained personnel, monitoring and measuring equipment.

6.2 6.2.1

Human Resources: General

The Management ensures that personnel who are assigned, responsibilities, under the Quality Management functions, are competent and are suitably qualified on the basis of education, training, skill and experience,

6.2.2

Competence, Awareness and Training

The organisation takes action to; Lay down competence requisites for personnel performing activities affecting Services Quality. Provide suitable training to satisfy these needs. Evaluate the effectiveness of the training provided. Ensure that its employees are aware of the relevance and importance of their activities and their contribution to achieve quality objectives. Maintain appropriate personnel records of education, skills /experience, training (4.2.4)

6.3
a b c

Infrastructure
The organisation also determines, provides and maintains the requisite infrastructure of facilities for achieving conformity of Service including Buildings, Workspace and associated Utilities. Process equipments, hardware and software. Supporting services such as transport or communication.

6.4

Work Environment
The organisation further identifies and manages, the human and physical factors of the work environment necessary to achieve conformity to Service requirements. APPROVED BY SIGNATURE DESIGNATION CMD ISSUED BY MR

DATE

05/08/07

05/08/07

VINAYAK HOSPITAL.
DOC.NO:VNKH/QMSM/01 ISO-9001:2000 PAGE :-1 of 4

QUALITY MANAGEMENT SYSTEM MANUAL SECTION:-7.0 TITLE:-Service Realisation

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7.0
7.1

Service Realisation Planning Of Service Realisation:

The planning for Service realisation are those sequence of processes and sub-processes required for achieving the Service quality. The organisation prepares Quality Plans that describe, how the processes of quality management system are applied in planning the processes for realisation of Service. The organisation determines the following, as appropriate: Quality objectives/Quality plans for the Service The need to establish processes and documentation and to provide resources specific to the Service Verification, validation, monitoring, inspection and test activities, specific to the Service and the criteria for acceptance. The records evidencing the realisation of the processes and conformance of the resulting Service, fulfill requirements. The Organisation determines Service realisation processes & acceptance criteria, through Quality Plans, of QMS for specific Service.

a) b) c) d)

7.2 7.2.1 a b c d

Customer Related Processes Determination of requirement related to the Service

The Organisation determines the customer requirements, which includes the following; Service requirements including availability, delivery and support as specified by the customer. Service requirements necessary for intended or specified use, if not specified by the customer. Statutory requirement and regulatory requirements of Service as applicable. Additional requirements as decided by the Organisation related to the Service.

7.2.2

Review of Requirements related to Service

The Organisation reviews, the identified customer requirements related to Service , together with additional requirements as determined (7.2.1 ) This review is conducted prior to the commitment to supply a Service to the customer ( e.g. submission of tender, acceptance of a contract or order), to ensure following:

a b c d e

Service requirements are defined. Where the customer does not provide any documented statement of requirements, the customer requirements are confirmed before acceptance. Contract or order requirements differing from that previously expressed are resolved. The organisation has the ability to meet the defined requirements. The results of the review and subsequent follow-up actions are recorded. (4.2.4) It is ensured that, wherever Service requirements are changed, the relevant documents are amended and the concerned persons are made aware of the changed requirements. APPROVED BY SIGNATURE ISSUED BY

DESIGNATION DATE

CMD 05/08/07

MR 05/08/07

VINAYAK HOSPITAL.
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7.2.3

Customer Communication
The Organisation identifies and implements, effective arrangements for communicating with the customer relating to following; Service information; Enquiries, contracts or order handling, including amendments. Customer feedback including Customer complaints.

a b c

7.4 7.4.1

Purchasing Purchasing Process:

The organisation controls its purchasing processes to ensure that purchased Products conform to specified purchase requirements. The type and extent of control applied to the suppliers and purchases Product depends upon the effect on subsequent Product realisation processes or the final Product . The organisation evaluates and selects suppliers based on their ability to supply Product in accordance with Organisations requirement. Criteria for selection evaluation and periodical reevaluation of suppliers are established. The results of evaluations and necessary follow up actions are recorded and maintained. (4.2.4)

7.4.2

Purchasing Information:
Purchasing documents contains information describing the Service to be purchased including, as appropriate, the following: Requirement for approval of Product, procedures, processes, and equipment. Requirement for Qualification of personnel Quality management system requirements The organisation ensures the adequacy of specified purchase requirements contained in the purchasing documents, prior to their communication to the supplier.

a b c

7.4.3

Verification of Purchased Product:

The organisation establishes and implements, inspection and other activities necessary for verification of the purchased Product a vis the specified purchase requirements. Where it is proposed either by the organisation or its customer, to perform verification activities at the suppliers premises, the intended verification arrangements and method of Product release, are clearly specified in the purchasing information. APPROVED BY ISSUED BY SIGNATURE

DESIGNATION DATE

CMD 05/08/07

MR 05/08/07

VINAYAK HOSPITAL.
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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:-7.0 TITLE:-Service Realisation

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7.5 7.5.1
a b c d e f

Service Provision: Control of Services :

The Organisation plans and controls all Services operations under controlled conditions including as applicable: Making available, information that describes the characteristics of the Service. Availability of work instructions, as necessary. Using and maintaining suitable Hospital and machinery. Availability and use of the monitoring and measuring devices Implementing of monitoring and measurement. The implementation of release, delivery and post-delivery activities.

7.5.2

Validation of processes for Services :

The organisation validates any processes for Services and service provisions where the resulting output cannot be verified by subsequent monitoring measurement. This includes any 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. The organisation defines and makes all arrangements for validation of the processes which include the following as applicable: Defined criteria for approval and review of processes Approval of equipment and qualification of personnel Use of defined methodology and procedures Requirements of records (4.2.4) Revalidation

a b c d e

7.5.3

Identification and Traceability:

The organisation identifies, where appropriate, the Patient by suitable means throughout Service realisation The organisation does identify the status of the Service with respect to monitoring and measurement requirements. The organisation does control and record the unique identification of the Patient, where Traceability is a requirement (4.2.4)

APPROVED BY SIGNATURE DESIGNATION CMD

ISSUED BY MR

DATE

05/08/07

05/08/07

VINAYAK HOSPITAL.
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7.5.4

Customer Property:
The organisation does exercise care with the customer property while it is under its control or being used by it. The organisation does identify, verify, protect and safeguard customer property provided for use or incorporation into the Service. Incidence of any loss, damage or unsuitability, of customer property is recorded and reported to the customer. Where applicable intellectual property are included as customer property.

7.5.5

Preservation of Product:
The organisation does preserve the conformity of the Product, including constituent parts, with the customer requirements during internal processing and delivery to the intended destination. This covers identification, handling, packaging, storage and protection.

7.6 a b c d e

Control of monitoring and measuring devices:

The organisation determines the monitoring and measurements to be carried out and the devices required for the purpose, to assure conformity of the Service to specified and determined requirements (7.2.1). The organisation puts in place appropriate processes to ensure that monitoring and measurement are carried out in a manner consistent with monitoring & measurement requirements. Where necessary, ensure valid results measuring equipments are: Verified at specified intervals and calibrated and adjusted prior to use, against traceable international or national measurement standards. Where no such standards exist, the basis used for calibration or verification is recorded. Adjusted or readjusted as necessary Identified to enable to determine the calibration status. Safe guarded from adjustments that would invalidate the calibrations/measurements results. Protected from damage and deterioration during handling, maintenance and storage. The organisation ensures that the result of calibration is recorded besides assessing and recording. The validity of previous results are assessed and recorded if the equipment is subsequently found to be out of calibration and taking corrective action on equipment and any Service affected. Records of results of calibration and verifications are maintained (4.2.4). Computer Software used if any, for measuring and monitoring of specified requirement. The ability of computer software to satisfy the intended applications is confirmed prior to use and reconfirmed as necessary.

APPROVED BY SIGNATURE DESIGNATION DATE CMD 05/08/07

ISSUED BY MR 05/08/07

VINAYAK HOSPITAL.
DOC.NO:VNKH/QMSM/01 ISO-9001:2000 PAGE :- 1 of 3

QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 8.0 TITLE :- Measurement, Analysis and Improvement

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8.0 8.1

Measurement, Analysis and Improvement: General:

The organisation does define, plan and implement the monitoring, measurement, analysis and improvement processes needed: To demonstrate conformity of the Service To ensure conformity of Quality Management System To continually improve the effectiveness of quality management system. This includes the determination of the applicable methods including statistical techniques and the extent of their use.

8.2

Monitoring and Measurement:

The organisation does monitor information relating to customer satisfaction and dissatisfaction as one of the measurements of performance of the quality management system. The organisation also monitors information relating to customer perception for fulfilment of customer requirement. The methodologies for obtaining and using this information are determined.

8.2.1 Customer Satisfaction:

8.2.2 Internal Audit:

The organisation conducts periodic planned internal audits to determine whether the quality management system Conforms to planned arrangement (7.1) of the requirements of the International Standard and to the Quality Management System established by the organisation and is effectively implemented and maintained. The organisation plans the audit program taking into consideration, the status and importance of the processes and areas to be audited, as well as the results of the previous audits. The audit criteria, scope, frequency and methods are defined. Selection of auditors and conduct the audits to bring about objectivity and impartiality of the audit process. Auditors do not audit their own work. A documented procedure specifying the responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (4.2.4) are defined in documented procedure VNKH/QP/17. Management takes timely corrective actions on deficiencies found and eliminate nonconformities and their causes detected, during the audit without undue delay. Follow up activities includes the verification of the implementation of corrective actions, and reporting of verification results.

APPROVED BY SIGNATURE DESIGNATION DATE CMD 05/08/07

ISSUED BY MR 05/08/07

VINAYAK HOSPITAL.
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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 8.0 TITLE :- Measurement, Analysis and Improvement

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8.2.3

Monitoring and Measurement of Processes:

The Organisation applies suitable methods for monitoring & where applicable measurement of QMS processes. These methods to demonstrate their ability to achieve planned results. When planned results are not achieved, appropriate correction & corrective action are taken to ensure conformity of the Service.

8.2.4

Monitoring and Measurement of Service:

The Organisation monitors and measures the characteristic of the Service, to verify that requirements for the Service are fulfilled. This is carried out at appropriate of the Service realisation process according to planned arrangement (7.1). Evidence of conformity with the acceptance criteria is documented. Records do indicate the person(s) authorising for release of Service (4.2.4) Service release does not proceed until all the planned arrangement have been satisfactorily completed, unless otherwise approved by the relevant authority and where applicable by the customer

8.3

Control of Non-Conforming Service :

The Organisation ensures that Service which does not confirm to the requirements is identified and controlled to prevent unintended use or delivery. The control and related responsibilities and authorities for dealing with non-conformance Service are defined in a documented procedure VNKH/QP/18. The organisation deals with nonconforming Services in one or more of the following ways: By taking action, to eliminate the detected non-conformity during Services and inspection. Records of nature of non-conformities and subsequent action taken, including concessions obtained, are maintained (4.2.4) Non-Conforming Service is corrected; it is re-verified after correction to demonstrate conformity to the requirements. When non-conformity is detected, after delivery or use has started the Organisation takes action appropriate to the effects, or potential effects of the non-conformity. It is often required that the proposed rectification of the non-conforming Service is reported for concession to the customer.

a b c d

8.4
a

Analysis of data:
The Organisation collects and analyses appropriate data to determine the suitability and effectiveness of the Quality Management System and to evaluate 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. APPROVED BY SIGNATURE DESIGNATION DATE CMD 05/08/07 ISSUED BY MR 05/08/07

VINAYAK HOSPITAL.
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QUALITY MANAGEMENT SYSTEM MANUAL SECTION:- 8.0 TITLE :- Measurement, Analysis and Improvement

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b c d

The Organisation analyses this data, to provide information on: Customer satisfaction (8.2.1) Conformance to Service requirements (7.2.1) Characteristics and trends of processes and Services including opportunities for preventive action. Suppliers

8.5 8.5.1

Improvement Continual Improvement:

The organisation 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 organisation takes actions to eliminate the cause of non-conformity in order to prevent recurrence. Corrective actions are appropriate to the effect of non-conformities encountered. The documented procedure VNKH/QP/19 for corrective action defines requirements for: Reviewing Non-conformities (including customer complaints) Determining the causes of non-conformities. Evaluating the need for actions to ensure that non-conformities do not recur. Determining and implementing the action needed Recording results of action taken (4.2.4) and Reviewing of Corrective action taken.

8.5.3

Preventive Action:
The organisation determines action to eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive action taken are appropriate to the effect of the potential problems. The documented procedure VNKH/QP/19 for preventive action defines requirements for : Determining potential non-conformities and their causes Evaluating the need for action, to prevent occurrence of non-conformities Determining and implementing preventive action needed. Recording results of action taken (4.2.4) Reviewing of preventive action taken.

a b c d e

APPROVED BY SIGNATURE DESIGNATION DATE CMD 05/08/07

ISSUED BY MR 05/08/07

VINAYAK HOSPITAL.
DOC.NO:VNKH/QMSM/01 ISO-9001:2000 PAGE :-1 of 1 Sr.No. 1 2 3 4 5 6 7 8 09 10 11 12 13 14 15 16 17 18

QUALITY MANAGEMENT SYSTEM MANUAL Annexure-IV TITLE: List Of Procedures

Procedure No.
VNKH/QP/01 VNKH/QP/02 VNKH/QP/03 VNKH/QP/04 VNKH/QPR VNKH/QP/05 VNKH/QP/06 VNKH/QP/07 VNKH/QP/08 VNKH/QP/09 VNKH/QP/10 VNKH/QP/11 VNKH/QP/12 VNKH/QP/13 VNKH/QP/14 VNKH/QP/15 VNKH/QP/16 VNKH/QP/17 VNKH/QP/18

REV DATE ISSUE DATE

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Rev
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Date
05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07 05/10/07

Documentation Requirement Human Resources Customer Related Processes Purchasing Hospital Services Operation theatre Surgeries Patient handling Pathology Radiology Dietary Equipment maintenance Laundry Front office Housekeeping Control of Monitoring & Measuring Devices. Monitoring And Measurement Control of Non Conforming Service Continual Improvement

APPROVED BY SIGNATURE DESIGNATION DATE CMD 05/08/07

ISSUED BY MR 05/08/07

VINAYAK HOSPITAL.
DOC.NO:VNKH/QMSM/01 ISO-9001:2000 PAGE :-1 of 1 Sr.No.

QUALITY MANAGEMENT SYSTEM MANUAL Annexure-V TITLE: List Of Work Instructions

No.

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Work Instructions

Rev.

Date

APPROVED BY SIGNATURE DESIGNATION DATE CMD 05/08/07

ISSUED BY MR 05/08/07

VINAYAK HOSPITAL.

DOC.NO:VNKH/QMSM /01 ISO-9001:2000 PAGE :-1 of 1 Sr.No.

QUALITY MANAGEMENTSYSTEM MANUAL Annexure-V I TITLE: List Of Records

Records No.

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Rev.

Date

APPROVED BY SIGNATURE DESIGNATION DATE CMD 05/08/07

ISSUED BY MR 05/08/07