roject Quality Management,

21. THE PATIENT

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

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.

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.

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 .

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