1.
<ul><li>PROJECT QUALITY MANAGEMENT </li></ul><ul><li>BY </li></ul><ul><li>Asim Shahzad </li></ul><ul><li>E-mail Address : asimshahzad78 @hotmail.com </li></ul>

2.
CONTENTS OF PRESENTATION <ul><li>WHAT IS ISO </li></ul><ul><li>WHAT IS ISO 9000 </li></ul><ul><li>PROJECT REQUIREMENTS OF ISO 9000 </li></ul><ul><li>WHAT IS QUALITY </li></ul><ul><li>STANDARD DEFINITION OF QUALITY </li></ul><ul><li>WHO IS YOUR CUSTOMER </li></ul><ul><li>5Ms THEORY </li></ul><ul><li>PROJECT STANDARD CLAUSES </li></ul><ul><li>QUESTIONS AND ANSWERS </li></ul>

3.
WHAT IS ISO <ul><li>ISO STANDS FOR “INTERNATIONAL </li></ul><ul><li>ORGANIZATION FOR STANDARDIZATION” </li></ul><ul><li>ISO IS A GREEK WORD WHICH MEANS </li></ul><ul><li>EQUAL, SIMILAR </li></ul>

4.
<ul><li>WHAT IS ISO STANDARD </li></ul><ul><li>ISO IS THE SPECIALIZED INTERNATIONAL </li></ul><ul><li>AGENCY FOR STANDARDIZATION </li></ul><ul><li>COMPRISING “ NATIONAL STANDARD </li></ul><ul><li>BODIES ” FROM 155 COUNTRIES </li></ul><ul><li>INCLUDING PAKISTAN AND IS SITUATED </li></ul><ul><li>AT GENEVA, SWITZERLAND. </li></ul>

5.
WHAT IS ISO 9000 <ul><li>IT IS AN INTERNATIONALLY RECOGNIZED </li></ul><ul><li>SERIES OF STANDARDS FOR THE </li></ul><ul><li>IMPLEMENTION OF QUALITY MANAGEMENT SYSTEM for example :- </li></ul><ul><li>ISO 8000 SOCIAL ACCOUNTABILITY </li></ul><ul><li>ISO 9000 QUALITY MANAGEMENT SYSTEM </li></ul><ul><li>ISO 10000 QUALITY SYSTEM AUDITING </li></ul><ul><li>ISO 14000 ENVIRONMENT MANAGEMENT SYSTEM, etc. etc . </li></ul>

6.
<ul><li>PROJECT REQUIREMENTS OF ISO 9000 </li></ul><ul><li>WRITE WHATEVER YOU DO </li></ul><ul><li>DO WHATEVER YOU WRITE </li></ul><ul><li>BE ABLE TO PROVE IT </li></ul>

7.
PROJECT QUALITY MANAGEMENT <ul><li>EQUIPMENT </li></ul>PEOPLE ENVIRONMENT PROCESSES MATERIAL FIVE ELEMENTS REQUIRING CONTROL BY A DOCUMENTED PROJECT QUALITY MANAGEMENT SYSTEM.

8.
PROJECT QUALITY MANAGEMENT SYSTEM <ul><li>MUST BE LED BY TOP MANAGEMENT OR CHIEF EXECTIVE OFFICER </li></ul><ul><li>FORM PROJECT TEAM (DEPARTMENTAL HEADS) </li></ul><ul><li>APPOINT A PROJECT COORDINATOR OR MANAGEMENT REPRESENATIVE </li></ul><ul><li>DOCUMENT MANUAL, PROCEDURES, WORK INSTRUCTIONS OF DEPT. </li></ul><ul><li>INTERPRET ISO9000 REQUIRMENTS INTO EACH DEPARTMENT </li></ul><ul><li>CONDUCT INTERNAL AUDITS IN DEPARTMENTS </li></ul><ul><li>INITIATE CORRECTIVE AND PREVENTIVE ACTIONS </li></ul><ul><li>IMPLEMENT OF THE PROJECT QUALITY MANAGEMENT SYSTEM </li></ul><ul><li>CERTIFICATION AUDIT BY THE CERTIFICATION BODY </li></ul>

10.
WHAT IS QUALITY <ul><li>i CUSTOMER REQUIREMENTS </li></ul><ul><li>ii CUSTOMER NEEDS </li></ul><ul><li>iii CUSTOMER EXPECTATIONS </li></ul><ul><li>iv FITNESS FOR USE OR PURPOSE </li></ul>

11.
STANDARD DEFINITION OF QUALITY <ul><li>QUALITY IS THE “ TOTALITY OF </li></ul><ul><li>FEATURES AND CHARACTERISTICS OF </li></ul><ul><li>A PRODUCT OR SERVICE THAT BEARS </li></ul><ul><li>ON ITS ABILITY TO SATISFY STATED </li></ul><ul><li>OR IMPLIED NEEDS ”. </li></ul>

12.
DIMENSIONS OF QUALITY <ul><li>Is it suitable for the intended job? Performance </li></ul><ul><li>Are the needs correctly translated? Design </li></ul><ul><li>Is it made as per design? Conformance </li></ul><ul><li>How frequently will it fail? Reliability </li></ul><ul><li>How long will it last? Durability </li></ul><ul><li>How easy will it be to repair it? Serviceability </li></ul><ul><li>What does it look like? Aesthetics </li></ul><ul><li>What else can it do? Features </li></ul><ul><li>Does the company/product has </li></ul><ul><li>reputation? Perceived Quality </li></ul>

13.
<ul><li>QUALITY PROBLEMS DUE TO </li></ul><ul><li>“ Management is 94 percent responsible for quality related issues in any organization” </li></ul><ul><li> Dr. Deming </li></ul><ul><li>(Father of TQM) </li></ul>

14.
QUALITY GURUS SAY <ul><li>QUALITY IS NEVER AN ACCIDENT, IT </li></ul><ul><li>IS ALWAYS THE RESULT OF HIGH </li></ul><ul><li>INTENTION, SINCERE EFFORTS, </li></ul><ul><li>INTELLIGENT DIRECTIONS AND </li></ul><ul><li>SKILLFUL EXECUTION. </li></ul>

15.
ISO 9001, QUALITY SYSTEMS <ul><li>MODEL FOR QUALITY ASSURANCE IN </li></ul><ul><li>USE WHEN CONFORMANCE TO </li></ul><ul><li>SPECIFIED REQUIREMENTS IS TO BE </li></ul><ul><li>ASSURED BY THE ORGANIZATION </li></ul><ul><li>DURING DESIGNING, DEVELOPMENT, </li></ul><ul><li>PRODUCTION, INSTALLATION AND </li></ul><ul><li>SERVICING. </li></ul>

16.
ISO 9002, QUALITY SYSTEMS <ul><li>MODEL FOR QUALITY ASSURANCE IN </li></ul><ul><li>USE WHEN CONFORMANCE TO </li></ul><ul><li>SPECIFIED REQUIREMENTS IS TO BE </li></ul><ul><li>ASSURED BY THE ORGANIZATION </li></ul><ul><li>DURING PRODUCTION, INSTALLATION </li></ul><ul><li>AND SERVICING. </li></ul>

17.
ISO 9003, QUALITY SYSTEMS <ul><li>MODEL FOR QUALITY ASSURANCE IN </li></ul><ul><li>USE WHEN CONFORMANCE TO </li></ul><ul><li>SPECIFIED REQUIREMENTS IS TO BE </li></ul><ul><li>ASSURED BY THE SUPPLIER AT FINAL </li></ul><ul><li>INSPECTION AND TEST. </li></ul>

18.
<ul><li>QUALITY ASSURANCE MODELS </li></ul><ul><li>ISO 9001 </li></ul><ul><li>1. DESIGN & DEVELOPMENT </li></ul><ul><li>2. PRODUCTION </li></ul><ul><li>3. INSTALLATION </li></ul><ul><li>4. SERVICING </li></ul><ul><li>ISO 9002 </li></ul><ul><li>1. PRODUCTION </li></ul><ul><li>2. INSTALLATION </li></ul><ul><li>3. SERVICING </li></ul><ul><li>ISO 9003 </li></ul><ul><li>1. FINAL INSPECTION AND TEST </li></ul>

19.
QMS AT HOSPITAL <ul><li>TO GENERALIZE THE IMPLEMENTATION OF </li></ul><ul><li>PROJECT QUALITY MANAGEMENT EXAMPLE OF A HOSPITAL IS CONSIDERED </li></ul><ul><li>IN THE TODAY’S PRESENTATION. </li></ul>

21.
THE PATIENT

22.
<ul><li>TYPES OF PATIENTS </li></ul><ul><li>* INDOOR </li></ul><ul><li>* OUT DOOR </li></ul><ul><li>* OUTSIDE THE HOSPITAL </li></ul><ul><li>* PARENTS OF SICK CHILDREN </li></ul>

23.
<ul><li>EXPECTATIONS OF CUSTOMERS </li></ul><ul><li>IMMEDIATE ATTENTION & CARE </li></ul><ul><li>LOVE AND AFFECTION </li></ul><ul><li>HIGH QUALITY TREATMENT </li></ul>

24.
<ul><li>EXPECTATIONS OF CUSOMERS CONTINUE… </li></ul><ul><li>EARLY APPOINTMENT FOR CONSULTATION / ADMISSION </li></ul><ul><li>MINIMUM WAITING TIME FOR TESTS & REPORTING e.g. X-RAY, LABS, ETC. </li></ul><ul><li>QUALITY CONSULTATION SERVICES </li></ul><ul><li>PROMPT INFORMATION SERVICES </li></ul>

25.
<ul><li>QUALITY SERVICES FOR PATIENTS </li></ul><ul><li>IT SHOULD BE BASED ON :- </li></ul><ul><li>INTERNATIONAL STANDARDS e.g. WHO </li></ul><ul><li>QUALIFIED AND EXPERIENCED STAFF </li></ul><ul><li>QUALITY CONTROLLED LABS TESTS </li></ul><ul><li>AVAILABILITY OF QUALITY MEDICINES </li></ul><ul><li>PROMPT HOSPITALIZATION SERVICES </li></ul><ul><li>PROMPT EMERGENCY SERVICES </li></ul>

26.
<ul><li>HOSPITAL TO PROVIDE </li></ul><ul><li>PROJECT QUALITY MANAGEMENT SERVICES TO ALL THE PATIENTS </li></ul>

27.
<ul><li>SATISFACTION OF PATIENTS BASED ON 5Ms THEORY </li></ul><ul><li>MENPOWER </li></ul><ul><li>MATERIALS </li></ul><ul><li>MACHINES </li></ul><ul><li>METHODS </li></ul><ul><li>MEASUREMENTS </li></ul>

28.
MENPOWER <ul><li>RECRUITMENT ON MERIT BASIS </li></ul><ul><li>QUALIFIED AND EXPERIENCED </li></ul><ul><li>JOB DESCRIPTION FOR EMPLOYEES </li></ul>

29.
MATERIALS <ul><li>ALL MATERIALS USED IN THE HOSPITAL </li></ul><ul><li>SHOULD HAVE STANDARD </li></ul><ul><li>SPECIFICATIONS AND APPROVAL FROM </li></ul><ul><li>THE COMPETENT AUTHORITY </li></ul>

30.
MACHINES <ul><li>ALL ELECTRO-MEDICAL EQUIPMENTS </li></ul><ul><li>SHOULD BE QUALIFIED AND APPROVED BY </li></ul><ul><li>THE COMPETENT AUTHORITY, FOR EXAMPLE :- </li></ul><ul><ul><li>RESPIRATOR </li></ul></ul><ul><ul><li>ANESTHESIA EQUIPMENT </li></ul></ul><ul><ul><li>ECG MACHINES </li></ul></ul><ul><ul><li>DIALYSIS MACHINE </li></ul></ul><ul><ul><li>DISPOSABLE EQUIPMENT </li></ul></ul><ul><ul><li>OFFICE EQUIPMENT etc. etc </li></ul></ul>

31.
METHODS <ul><li>ALL PROCEDURES / INSTRUCTIONS </li></ul><ul><li>SHOULD BE QUALIFIED AND APPROVED </li></ul><ul><li>BY THE COMPETENT AUTHORITY LIKE </li></ul><ul><li>OPERATION THEATRE </li></ul><ul><li>MEDICAL STORE </li></ul><ul><li>ADMISSION/DISCHARGE OF PATIENT </li></ul><ul><li>PURCHASING </li></ul><ul><li>HIRING OF HOSPITAL STAFF </li></ul><ul><li>CALIBERATION OF EQUIPMENT </li></ul><ul><li>LABORATORY TESTS </li></ul>

32.
MEASUREMENTS <ul><li>ALL INSTRUMENTS AND EQUIPMENTS MUST </li></ul><ul><li>BE INSPECTED AND CALIBRATED BY THE </li></ul><ul><li>NATIONAL STANDARD LABORATORY e.g. </li></ul><ul><li>FLOW METERS </li></ul><ul><li>PRESSURE GAUGES </li></ul><ul><li>TEMPERATURE GAUGES </li></ul><ul><li>LABORATORY EQUIPMENTS ETC. </li></ul>

33.
PROJECT QUALITY MANAGEMENT SYSTEM FOR ISO 9000 <ul><li>BASED UPON 5Ms THEORY, ISO9000 QUALITY MANAGEMENT SYSTEM PROVIDES A STRUCTURE THAT CAN BE USED BY HOSPITAL AT ALL LEVELS AND IN ALL FUNCTIONS TO ACCOMPLISH ITS TASKS IN A COMPARATIVELY BETTER AND COST EFFECTIVE MANNER. </li></ul>

34.
CLAUSES OF ISO 9000 4.1 MANAGEMENT RESPONSIBILITY 4.2 QUALITY SYSTEM 4.3 CONTRACT REVIEW 4.4. DESIGN CONTROL 4.5 DOCUMENT AND DATA CONTROL 4.6 PURCHASING 4.7 CUSTOMER SUPPLIED PRODUCT 4.8 PRODUCT IDENTIFICATION AND TRACEABILITY 4.9 PROCESS CONTROL 4.10 INSPECTION AND TESTING 4.11 CONTROL OF INSPECTION AND MEASURING EQUIPMENT 4.12 INSPECTION AND TEST STATUS 4.13 CONTROL OF NON- CONFORMING PRODUCT 4.14 CORRECTIVE AND PREVENTIVE ACTION 4.15 HANDLING, STORAGE, PACKAGING AND RESERVATION 4.16 CONTROL OF QUALITY RECORD 4.17 INTERNAL QUALITY AUDITS 4.18 TRAINING 4.19 SERVICING 4.20 STATISTICAL TECHNIQUES

35.
4.1 MANAGEMENT RESPONSIBILITY

36.
QUALITY POLICY

37.
4.2 QUALITY MANAGEMENT THE HOSPITAL SHALL ESTABLISH, DOCUMENT AND MAINTAIN ITS QUALITY SYSTEM AND ENSURE THAT ALL SERVICES CONFORM TO SPECIFIED REQUIREMENTS.

38.
PROJECT QUALITY MANAGEMENT Standard ISO 9000 Quality Manual Policy Statement Level 1 Commitment, Organization, Responsibilities Procedures Company Practice & Level 2 Interfaces Work Instructions Written Instructions Level 3 to control Tasks Forms Quality Records Level 4 Sales Design Purchasing Manufacturer Accounts Personnel After Sales

39.
QUALITY MANUAL <ul><li>QUALITY POLICY </li></ul><ul><li>OBJECTIVES </li></ul><ul><li>OVERVIEW </li></ul><ul><li>ORGANIZATION </li></ul><ul><li>RESPONSIBILITIES </li></ul><ul><li>REQUIREMENTS </li></ul><ul><li>POLICY/REFERENCE </li></ul>

40.
QUALITY SYSTEM PROCEDURES <ul><li>A SET OF PROCEDURES WHICH DETAIL HOW THE REQUIREMENTS OF THE QUALITY MANUAL ARE TO BE IMPLEMENTED. </li></ul><ul><li>DETAILED PROCEDURES WHICH DEFINE HOW THE PROCESSES ARE TO BE PERFORMED AND CONTROLLED. </li></ul><ul><li>SPECIFYING WHO IS RESPONSIBLE FOR DOING WHAT? </li></ul>

41.
WORK INSTRUCTIONS <ul><li>DETAILED INSTRUCTIONS FOR THE PERFORMANCE OF SPECIFIC TASKS. </li></ul><ul><li>ON THE SHOP FLOOR, LAB, etc </li></ul><ul><ul><li>MATERIALS </li></ul></ul><ul><ul><li>PROCESSES </li></ul></ul>

42.
4.3 CONTRACT REVIEW <ul><li>THE HOSPITAL SHALL REVIEW THE REQUIRMENTS OF THE REPORTING PATIENT (CUSTOMER) AND ENSURE THAT :- </li></ul><ul><ul><li>PATIENT REQUIREMENTS AND SPECIFICATIONS ARE DEFINED. </li></ul></ul><ul><ul><li>ASCERTAIN THAT THE HOSPITAL </li></ul></ul><ul><li>CAN MEET THESE SPECIFICATIONS </li></ul>

43.
4.4 DESIGN CONTROL THE HOSPITAL SHALL ESTABISH AND MAINTAIN DOCUMENTED PROCEDURES TO CONTROLL AND VERIFY THE MOST SUITABLE SERVICES FOR THE PATIENT IN ORDER TO ENSURE THAT THE SPECIFIED REQUIRMENTS ARE FULFIELD.

44.
4.5 DOCUMENT AND DATA CONTROL <ul><li>THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES TO CONTROL ALL DOCUMENTS AND DATA GENERATED IN THE HOSPITAL. </li></ul><ul><li>DATA INCLUDES DATA SHEETS, LAB TESTS AND PATIENT RECORDS ETC. ETC. </li></ul>

45.
4.6 PURCHASING THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES TO ENSURE THAT PURCHASED ITEMS CONFORMS TO SPECIFIED REQUIRMENTS. FOR EXAMPLES :- LIKE MEDICINES, SURGICAL INSTRUMENTS, HOSPITAL FURNITURES, FOOD ITEMS, LABORATORY EQUIPMENTS, ETC.

46.
4.7 CONTROL OF CUSTOMER SUPPLIED PRODUCT <ul><ul><li>THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES FOR THE CONTROLL OF VERIFICATION, STORAGE AND MAINTENANCE OF CUSTOMER SUPPLIED PRODUCTS. </li></ul></ul><ul><ul><li>FOR EXAMPLE LAB SAMPLES, PATIENT’S OLD RECORDS ETC. </li></ul></ul>

47.
4.8 PRODUCT IDENTIFICATION AND TRACEABILITY WHERE APPROPRIATE, THE HOSPITAL SHALL ESTABLISH AND MAINTAIN THE DOCUMENTED PROCEDURES FOR IDENTIFYING PATIENT, MATERIAL AND SERVICES BY SUITABLE MEANS.

48.
4.9 PROCESS CONTROL THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES TO IDENTIFY AND PLAN THE TREATMENT AND OTHER SERVICING PROCESSES TO ENSURE THAT THE SAME ARE CARRIED OUT UNDER CONTROLLED CONDITIONS.

49.
4.10 INSPECTION AND TESTING THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES FOR INSPECTION AND TESTING ACTIVITIES IN ORDER TO VERIFY THAT THE SPECIFIED REQUIRMENTS FOR PATIENTS AND ALSO FOR ALL INCOMING MATERIALS ARE MET.

50.
4.11 CONTROL OF INPSECTION, MEASURING & TEST EQUIPMENT ALL INSTRUMENTS AND EQUIPMENTS USED IN THE HOSPITAL SHOULD BE INSPECTED AND CALIBERATED ACCORDING TO THE DOCUMENTED PROCEDURES APPROVED BY THE COMPETENT AUTHORITY. NON CALIBERATED INSTRUMENTS SHOULD NOT BE USED

51.
4.12 INSPECTION AND TEST STATUS THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES FOR ALL INCOMING MATERIALS AND PATIENT’S TEST SAMPLES TO ENSURE THAT THEIR TEST STATUS (CONFORMANCE OR NON-CONFERMANCE) IS PROPERLY IDENTIFIED BY SUITABLE MEANS.

52.
4.13 CONTROL OF NON-CONFORMING PRODUCTS THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURE TO ENSURE THAT ALL INCOMING MATERIALS LIKE MEDICINES, SURGICAL INSTRUMENTS, LABORATORY EQUIPMENT, HOSPITAL FURNITURE ETC THAT DO NOT CONFORM TO SPECIFIED REQUIREMENTS ARE PREVENTED FROM UN-INTENDED USE OR INSTALLATION.

53.
4.14 CORRECTIVE AND PREVENTIVE ACTION THE HOSPITAL SHALL ESTABLISH AND MAINTAIN DOCUMENTED PROCEDURES FOR IMPLEMENTING CORRECTIVE AND PREVENTIVE ACTION TO ELIMINATE THE CAUSES OF ACTUAL OR POTENTIAL NON- CONFORMITIES.

54.
4.15 HANDLING, STORAGE, PACKING, PRESERVATION AND DELIVERY THE ORGANIZATION SHALL PROVIDE ADEQUATE HANDLING, STORAGE, PRESERVATION, PACKAGING, AND DELIVERY OF YOUR PRODUCT TO ENSURE THAT IT MEETS SPECIFIED REQUIREMENT .

55.
4.16 CONTROL OF QUALITY RECORDS <ul><li>THE ORGANIZATION SHALL ESTABLISH </li></ul><ul><li>AND MAINTAIN DOCUMENTED </li></ul><ul><li>PROCEDURES FOR IDENTIFICATION, </li></ul><ul><li>COLLECTION, INDEXING, ACCESS, </li></ul><ul><li>FILLING, STORAGE, MAINTENANCE AND </li></ul><ul><li>DISPOSITION OF QUALITY RECORDS. </li></ul>

56.
4.17 INTERNAL QUALITY AUDITS <ul><li>THE INTERNAL QUALITY AUDIT SHALL </li></ul><ul><li>IMPROVE THE EFFECTIVE IMPLEMEN- </li></ul><ul><li>TAION OF ALL THE PROCEDURES AND </li></ul><ul><li>QUALITY SYSTEMS. THIS ACTIVITY WILL </li></ul><ul><li>HELP TO IDENTIFY AND IMPROVE THE </li></ul><ul><li>NON-CONFORMANCES AND ITS </li></ul><ul><li>EFFECTIVENESS FOR THE QUALITY </li></ul><ul><li>SYSTEM. </li></ul>

57.
PURPOSE OF AUDITS <ul><li>TO DETERMINE IF THE QUALITY SYSTEM IS OPERATING AND IS EFFECTIVE </li></ul><ul><li>TO DETERMINE THE DEGREE OF COMPLIANCE TO THE SPECIFIED STANDARD. </li></ul><ul><li>TO DETERMINE THE DEGREE OF COMPLIANCE TO THE REGULATORY REQUIREMENTS (HEALTH AND SAFETY/ ENVIRONMENTAL ETC). </li></ul><ul><li>TO ENABLE CERTIFICATION OF THE SYSTEM. </li></ul><ul><li>WHEN THE QUALITY OF THE PRODUCT OR SERVICE IS SUSPECT </li></ul><ul><li>TO DETERMINE IF IMPROVEMENTS CAN BE MADE. </li></ul>

58.
AUDITING <ul><li>AUDITING IS A FACT FINDING TASK </li></ul><ul><li>NOT A POLICING OPERATION. </li></ul><ul><li>QUALITY CONTROL IS A POLICING </li></ul><ul><li>OPERATION </li></ul>

59.
AUDIT DEFINITIONS <ul><li>LEAD AUDITOR </li></ul><ul><li>A PERSON APPOINTED TO MANAGE THE AUDIT. </li></ul><ul><li>THE AUDITOR: </li></ul><ul><li>A PERSON QUALIFIED TO PERFORM QUALITY AUDITS. </li></ul><ul><li>AUDITEE </li></ul><ul><li>ORGANIZATION (OR PERSON) BEING AUDITED </li></ul>

60.
CHECKLISTS <ul><li>USED BY THE ASSESSOR AS AN AIDE MEMOIRE. </li></ul><ul><li>ENSURE THAT ALL ELEMENTS OF A SPECIFICATION ARE ADDRESSED. </li></ul><ul><li>ARE COMPILED FROM THE RESULTS OF A DETAILED STUDY OF THE PROCEDURE/SPECIFICATION. </li></ul><ul><li>ENSURE THAT ALL RELEVANT REQUIREMENTS CONTAINED IN THE SPECIFICATION ARE COVERED. </li></ul>

61.
4.18 TRAINING <ul><li>THE HOSPITAL SHALL IDENTIFY </li></ul><ul><li>TRAINING NEEDS OF OFFICERS AND </li></ul><ul><li>PARAMEDIC’S STAFF PERFORMING </li></ul><ul><li>THOSE ACTIVITIES WHICH AFFECT </li></ul><ul><li>QUALITY. </li></ul><ul><li>PERSONNEL PERFORMING ASSIGNED </li></ul><ul><li>DUTIES SHALL BE QUALIFIED ON THE </li></ul><ul><li>BASIS OF SPECIFIED EDUCATION, </li></ul><ul><li>TRAINING, EXPERIENCE AS REQUIRED. </li></ul>

62.
<ul><li>THE HOSPITAL SHALL ESTABLISH </li></ul><ul><li>AND MAINTAIN DOCUMENTED </li></ul><ul><li>PROCEDURES FOR PATIENT’S VISIT </li></ul><ul><li>FOR THE FOLLOW-UP CONSULTATION </li></ul><ul><li>AND TREATMENT AS PER APPROVED </li></ul><ul><li>POLICY BY THE COMPETENT </li></ul><ul><li>AUTHOURITY. </li></ul>4.19 SERVICING

63.
4.20 STATISTICAL TECHNIQUES THE ORGANIZATION SHALL IDENTIFY THE NEED FOR STATISTICAL TECHNIQUES REQUIRED FOR ESTABLISHING, CONTROLLING AND VERIFYING PROCESS CAPABILITY AND PRODUCT CHARACTRISTICS.

64.
SIX MYTHS ABOUT ISO 9000 MYTH-1: ONCE YOU HAVE GOT ISO 9000, YOU CAN ONLY BUY FROM OTHER ISO 9000 COMPANIES. MYTH -2: ISO 9000 IS ONLY FOR BIG COMPANIES. MYTH-3: IT PRODUCES LOTS OF PAPER WORK. MYTH-4: IT REQURES LOTS OF EXTRA STAFF. MYTH-5: IT IS ONLY FOR MANUFACTURERS. MYTH-6: ISO 9000 WOULD FORCE US TO ADOPT A SPECIFIC LEVEL OF QUALITY PERHAPS LOWER THAN WE ALREADY HAVE.

65.
KEY BENEFITS OF ISO 9000 1. ORGANIZATION WIDE QUALITY MANAEMENT SYSTEM. 2. LESS REWORK, REDUCED MATERIAL AND LESS WASTAGE OF RESOURCES. 3. GREATER PRODUCTIVITY AND COST REDUCTION 4. UP-GRADING BUSINESS TO THE WORLD CLASS LEVEL 5. WORLDWIDE RECOGNITION 6. IMPROVEMENT IN COMPANY WIDE PERFORMANCE 7. ACHIEVEMENT / MAINTENANCE OF PRODUCT/SERVICE QUALITY 8. BETTER CONSISTENCY IN PRODUCTION WORK 9. OPPORTUNITY TO COMPETE WITH LARGER ORGANIZATION

66.
ACCREDITATION SCHEME <ul><li>Department of Trade & Industry Example shown for UK </li></ul><ul><li> DTI Registration </li></ul><ul><li>United Kingdom Accreditation Service </li></ul><ul><li>UKAS </li></ul>Accredit Certification Bodies Calibration & Test Houses Certify Companies/Organizations