The document discusses ISO 9001:2008 and quality management systems. It explains that ISO 9001:2008 promotes a process approach and systems approach when developing, implementing, and improving quality management systems. An effective quality management system is achieved through identifying, managing, and improving interrelated processes and ensuring their interaction meets organizational objectives.

1. ISO 9001:2008 PROCESS APPROACH QUALITY MANAGEMENT SYSTEM

2. PHILOSOPHY OF THE SYSTEM No one wants to make a mistake. Everyone wants to do a good job. All problems are traceable to system issues. System is an outcome of a policy. A Good Policy leads to a Good System. A bad system implies outdated Policy. A Policy creates a good environment. Corrective Measures and Improvement should be System related. Customer Satisfaction only through meeting expectations. Everyone in the organization should be involved. The best way is through a System. Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

3. COMMON SYSTEM PROBLEMS No system No communication Not suitable Not effective Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

4. CORRECT UNDERSTANDING OF A GOOD SYSTEM Organisation has certain objectives to be achieved This should be achieved not by individual excellence, but through an effective integrated system Achieving the organisational objectives will be the same as getting the desired benefits from the system Any system should be defined through an input, process and output model. Continued… Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

5. CORRECT UNDERSTANDING OF A GOOD SYSTEM System is an environment which deploys the policy. The effectiveness of the system is the outcome of the effective deployment of the policy. The effective implementation of the system is based on the effective deployment of the system represented by policies and procedures into the organisation in the form of responsibilities and authorities. Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

6. EXAMPLES OF GOOD SYSTEMS Inspection System Corrective Action System Management Review System Training System Document Control System Quality Records System Recruitment System Measurement Analysis System Auditing System Etc. Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

7. WHAT IS ISO? International Organization for Standardization Worldwide federation of national standards; Bodies from some 130 countries Non-governmental organization, Established in 1947 Shouldn’t acronym be IOS ? ISO derived from Greek isos meaning “equal” Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

8. The new ISO 9000:2008 standards promote the adoption of PROCESS APPROACH and SYSTEMS APPROACH when developing, implementing and improving a Quality Management System (QMS). ISO 9001:2008 – PROCESS APPROACH Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

9. MODEL OF PROCESS BASED QMS Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre INPUT OUTPUT PROCESS MANAGEMENT PROCESS RESOURCE MANAGEMENT C U S T O M E R P D C A MEASUREMENT & ANALYSIS, IMPROVEMENT MANAGEMENT RESPONSIBILILTY R E Q. M E N T S I N T. P A R T I E S I N T. P A R T I E S

10. Process Approach: a desired result is achieved more efficiently when activities and related resources are managed as a process. System approach to management : identifying, understanding and managing of interrelated processes as a system of for a given objective contributes to the effectiveness and efficiency of the organization Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

11. ISO 9001:2008 REQUIRES.. An organization to.. Identify Implement Manage Continually improve the effectiveness of the processes necessary for Quality Management System and; Manage the interaction of these processes to achieve organization’s objective Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

12. WHAT IS A PROCESS? “ Set of interrelated or interacting activities which transform inputs into outputs” Outputs from one process are typically inputs to other processes. The overall aim is to add value by planning and controlling processes. Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

13. PRODUCT “ The result of a Process” Generic product categories : Hardware Processed Materials Software Services Combinations of the above 4 categories Tangible Intangible Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

14. WHAT IS A PROCESS? Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre Input (Includes Resources) Output PRODUCT OR SERVICE Procedure (“Specified way to carry out an activity or a process”) Monitoring and Measurement Opportunities } Effectiveness of Process Efficiency of Process

15. Dec 4, 2010 THE PROCESS APPROACH IMPLEMENTATION OF QMS Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

16. PROCESS IDENTIFIED BY ISO Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

17. PROCESS - INPUTS & OUTPUTS Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

18. Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

19. PROCESSES IMPORTANT IN YOUR ORGANIZATION HR Infrastructure Patient care Nursing, Diagnosis and Reporting Laboratory and Research Imaging and OT Purchase Financial Processes Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

20. DOCUMENTATION OF PROCESSES There is no "catalogue", or list of processes that must be documented. Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

21. DOCUMENTATION OF PROCESSES Possible methods that can be used to document processes are; Graphical representation Written instruction Checklists Flowcharts. Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

22. Organizations are Complex Systems Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre Human/ Cultural Structural Strategic Managerial Technological Organizational Systems Inputs: Human, Financial, Technological, Material, Resources Outputs: Products, Services Input-output flow of materials, energy, information

23. Organizations Resist Change Organizations undergoing process transition activities tend to focus on the technology rather than on the problems they are attempting to resolve Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre Human/ Cultural Structural Strategic Managerial Technological Social

24. Individual Paradigm Action Behavior Attitude Thinking Values Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

25. Organizational Paradigm Performance Processes Plans Principles Philosophy Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

26. IMPLEMENTATION QMS

27. Team-Work Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

28. REVISE Cross check all system documentation & revise as required. Improve Simplify Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

29. AUDIT Facilitates continuous improvement Conducted as frequently as necessary to ensure the integrity of the quality system Is not a policing action Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

30. CERTIFICATION Conducted by an independent third party An initial full audit of the Quality System followed up by yearly surveillance visits Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

31. BENEFITS QMS

32. INTERNAL BENEFITS Increased operational efficiency Opportunity to critically examine how employees do their work and interact between functions Systemic breakdowns are recognized and addressed Reduce errors associated with ”hand-offs” Development of “Best practice” hospital-wide processes, with reference to supporting documentation Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

33. INTERNAL BENEFITS Greater employee awareness about quality Cost savings from less scrap and rework Enhanced communication among employees Improve employees’ understanding of roles and responsibilities within the healthcare quality management system Alignment of Hospital-wide, Departments, Individual objectives Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

34. EXTERNAL BENEFITS Maximize customer satisfaction Improve public trust that the organization is concerned for patient safety and quality of care Competitive edge Increased credibility Perceived higher quality Fulfilling supplier requirements for registration Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

35. BASIC APPROACH OF QMS To develop, refine, review and update working practices - what is done? - why is it done? - where is the requirement met? - who is responsible? - how is it done? Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

36. DOCUMENTATION QMS

37. OBJECTIVES to develop a simplified format that will be in tune with the working practices; for the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities . Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

38. SCHEME OF DOCUMENTING THE MANAGEMENT SYSTEM Dec 4, 2010 Evidence of actions Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre Goals & objectives What\When\Who How

39. KEY QUALITY MANAGEMENT PRINCIPLES The eight Key Principles of ISO 9001:2008 are – Customer Focus Leadership Involvement of People Process Approach System Approach to Management Continual Improvement Factual Approach to Decision - Making. Mutually Beneficial Supplier Relationship Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre

40. Feedback Dec 4, 2010 Sai Shree Orthopaedic Super-Speciality & Joint Replacement Centre