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Business Case for Quality: International Standards

Business Case for Quality: International Standards. Rogerio Rabelo , MD, PhD, MBA – Senior Consultant and Product Manager Fleury Diagnostics . International Standards: understanding the ISO. ISO: International Organization for Standardization

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Business Case for Quality: International Standards

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  1. Business Case for Quality:International Standards Rogerio Rabelo, MD, PhD, MBA – Senior Consultant and Product Manager Fleury Diagnostics

  2. International Standards:understanding the ISO • ISO: • International Organization for Standardization • Non-governmental organization with members from international institutes of more than a hundred countries • Central office in Geneva, Switzerland • “ The main purpose of ISO is to develop standards internationally recognized, contributing to make thedevelopment, manufacturing and supply of products and services more efficient, safer and cleaner” • Certification and Accreditation: • According to ISO, a company which is found compliant to its standards and requirements is called “certified” • In the accreditation process, the term used is ”accredited” • For ISO, the company responsible for certifying an organization, after being checked and recognized by the authority bodies, is the one called “accredited”

  3. What are the main ISO standards applicable to clinical laboratories? ISO 9001:2000 - Quality Management System – Requirements ISO 15189:2003 – Medical laboratories- particular requirements for quality and competence ISO 14001:2004 - Environmental management systems - Requirements with guidance for use * ISO standards can be generic (used for certification purposes) or specific (guidelines for orientation)

  4. USA 30294 ISO 9001 certificates – Worldwide and the USA Source: The ISO survey of ISO 9001:2000 and ISO 14001 certificates - 2003

  5. Quality Management from ISO 9001:2000 perspective • ISO 9001: 2000 • Generic standard that states the requirements for the implementation of Quality Management System • Main objectives: to increase patient satisfaction and to promote continual improvement, leading to better results in the overall performance of the company • Based on eight principles: • Customer/patient-focused organization • Leadership • Involvement of people • Process approach • Systemic approach • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationships

  6. Quality Management from ISO 9001:2000 perspective

  7. Quality Management fromISO 15189:2003 perspective • ISO 15189:2003 • It states the main points to implement a Quality Management System in a clinical laboratory, using a more specific terminology • Its objective is to allow laboratories to organize their operational procedures efficiently, meet the expectations of their clients and improve their service • It includes Requirements for: • Pre-examination procedures • Examination procedures • Post-examination procedures • Equipment • Advisory services • Reporting of results, etc.

  8. Environmental issues fromISO 14001:2004 perspective • ISO 14001:2004 • Requirements for the implementation of Environmental Management Systems • It intends to improve the environmental performance of laboratories and other organizations • Providing them with tools to implement efficient environmental management systems • Making them able to achieve financial goals in a sustainable way • It is based on: • The identification of environmental aspects and impacts of an organization, and the measures taken to control them • Prevention of pollution • Compliance to environmental legal requirements

  9. Integrated Management System (IMS) • IMS: it is defined as the management of two or more internationally recognized standards in a compatible way by integrating common management principles shared by them • ISO 9001:2000 + ISO 14001:2004 • OHSA 18000 + ISO 14001:2004 • SA8000 + OHSA 18000 + ISO14001

  10. Continual Improvement Integrated Management System (IMS) - Benefits • Better integration and more effective management of related processes and departments • Cost reduction • Process standardization/optimization • Better control of documents and records • Continual improvement • Definition of a set of indicators oriented to the overall performance of the laboratory • Assurance of quality and safety  patient needs and satisfaction • If ISO 14001:2004 is part of it: • Compliance to environmental legal requirements • Pollution prevention

  11. Business case for Quality: why did Fleury Diagnostics choose ISO? • Because ISO standards are applicable to the laboratory as a whole, including administrative and financial areas • Because we wanted to standardize the processes before applying a more specific standard • Because ISO standards have a generic approach • They can be used as the basis for more specific accreditation standards (CAP, JCAHO) • They can be used as the basis for other management tools (Lean, Six Sigma) • Because ISO can also be used as a management standard to help the organization to achieve all expected results

  12. Fleury Diagnostics Background: Knowing the Lab to understand our IMS Where are we?

  13. Fleury Diagnostics –the Laboratory

  14. Fleury Diagnostics –the history and a philosophy • Private laboratory, founded in 1926 by Dr. Fleury • Patient focus as the main foundation • Physician-owned • Technology-driven • Knowledge-based • Intellectual capital • Teamwork & matrix structure • Ethics, respect and excellence • Equal opportunity • Very strong brand name: top-of-mind for patients and physicians • Control of the full process (from blood drawing to result reporting) One-stop testing

  15. Fleury Diagnostics – High-Quality Patient Service Centers • 16 Patient Service Centers for sample collection and diagnostic procedures: • 12 in metropolitan São Paulo • 1 in Jundiaí • 1 in Campinas • 1 in Brasília • 1 in Rio de Janeiro • 2 hospital-based fast-response labs • State-of-art, centralized technical/administrative headquarter • A very busy call center • 24 hours/day, 365 days/year • 60 attending positions, 130 employees (no outsourcing at all) • 5,000 calls/day

  16. Fleury Diagnostics –Integrated Diagnostic Services • Laboratory Medicine: • Clinical Chemistry • Special Chemistry • Immunology/Serology • Microbiology • Parasitology • Hematology/Cytology • Coagulation • Anatomical Pathology • Molecular Diagnostics • Cytogenetics • Toxicology • Point-of-care testing • Diagnostic Services: • Nuclear Medicine • Imaging • Cardiology • Neurology • Endoscopy • Gynecology • Fetal Medicine • GI motility • Ear, nose and throat • Pneumology • Urology • Ophthalmology • Genetic counselling • Check-up services • Non-diagnostic Services: • Diabetes Center • Immunization Center • Travel Medicine Center • Outpatient Surgery Center

  17. Our mission Provide and develop services and medical procedures, with ethics and technical excellence, to fulfill the needs of our clients Our values • Respect, trust, honesty and ethics on all relations with internal and external clients • Permanent investment in knowledge, talent, technological and scientific innovation • Equal opportunity for everyone, based on professional and personal competence • The company goals are above personal objectives • Commitment in service excellence Fleury’s Mission and Values

  18. Fleury’s ISO Integrated Management Policy • To perform and develop, with technical excellence and ethics, customer services and medical procedures, committing itself to the continual improvement of the services provided by: • Implementation and maintenance of the Integrated Management System (IMS) • Respect to the environment and prevention of pollution by complying with the applicable legislation and by treating the waste produced

  19. The Kids ISO’s 14000 Programme Fleury’s ISO Integrated Management Policy – Objectives • This policy is guided by five objectives: • Provide efficient management tools that contribute to continual improvement • Develop customer services in an efficient and respectful way, in order to answer the needs of our clients and exceed their expectations • Perform, with technical excellence and ethics, diagnostic and therapeutic procedures • Reduce the environmental impact of the medical procedures and services by the rational usage of natural resources and complying with legal requirements • Ensure continuous improvement of our IMS by setting up goals and effectively monitoring them

  20. 1999 2001 2002 Quality Assurance: ISO9001:1994 Transition: ISO 9001:1994  ISO 9001:2000 + ISO 14001:1996 Integrated Management System: ISO 9001:2000 ISO 14001:1996 ISO Standards at Fleury Diagnostics

  21. Fleury’s ISO 9001:1994 –the beginning • ISO 9001:1994 – focus on Quality Assurance • Implementation of process and operational indicators • Useful for monitoring specific processes and departments • Difficulties to identify the connection between the ISO System and its contribution to the overall performance of the laboratory and patient satisfaction • System considered by many employees as “bureaucratic and with plenty of papers to fill out”

  22. Quality Indicators –the beginning

  23. Fleury’s ISO 9001:2000 – the transition ISO 9001:2000 - Focus on Quality Management • Transition from Quality Assurance approach to Quality Management approach • Clear distinction between management and process indicators • Better definition of different groups responsible for evaluating the performance at different levels of the laboratory • The set of indicators were a mix of process and management indicators

  24. Quality & Management Indicators – the transition

  25. Fleury’s ISO 9001:2000 + ISO 14001:1996 – our current IMS • Integrated Management System: • ISO 9001:2000 + ISO 14001:1996 • Based on the strategic planning of the laboratory • Identification of patient satisfaction-oriented process indicators • Establishment of a more concise set of management indicators • Quality indicators monitoring the technical excellence of the analytical processes, but also providing information on patient needs and health care market • Use of the Balanced Scorecard approach to monitor them, with five strategic objectives • Defined by the strategic planning

  26. Fleury Diagnostics’Integrated Management System

  27. Fleury’s Differentials and strategic planning Counseling to physicians Best services PATIENT FOCUS: Reliability Problem solving Pleasant experience Personalized service Technical excellence HIGHLY QUALIFIED HUMAN CAPITAL STATE-OF-THE-ART TECHNOLOGY

  28. Better results and performance improvement The Balanced Scorecard Approach

  29. Financial Customer Internal business processes Learning and growth Indicator 39 Linking our mission, values and strategy to action: Balanced Scorecard Macrobjectives

  30. Quality Management Indicators/BSC metrics – continual improvement challenge

  31. INDICATOR CURRENT VALUE GOAL PERIOD STATUS CUSTOMER SATISFACTION SCORE 4,87 4,68 September/2004 Fleury’s IMS indicators/BSC metrics: Patient Perspective BALANCED SCORECARD – DECEMBER/2004 ver.02 (02/25/2005)Serve our client in a personalized, humanized way, exceeding their expectations

  32. Fleury’s IMS indicators/BSC metrics:Patient satisfaction surveys The clients were requested to give a 1 to 5 score to the quality of our services: 1 = “very unsatisfied” 5 = “very satisfied”

  33. Fleury’s IMS indicators/BSC metrics: Physician’s Perspective BALANCED SCORECARD – DECEMBER/2004 ver.02 (02/25/2005)Make all our staff and medical team totally focused on our client, developing and capacitating them to provide the best care, assuring the perpetuation of our company’s culture

  34. Fleury’s IMS indicators/BSC metrics: Internal Process Perspective BALANCED SCORECARD – DECEMBER/2004 ver.02 (02/25/2005)Obtain sustained growth and value generation for Fleury business and brand CURRENT CURRENT INDICATOR INDICATOR GOAL GOAL PERIOD PERIOD STATUS STATUS VALUE VALUE Percentage of patients in which blood had Percentage of patients in which blood had to be redrawn 0,191 % < 0,2 % December/2004 to be redrawn Redraw 2004 0,3 120 0,25 100 0,2 80 % 60 0,15 Patients 40 0,1 Number of 20 0,05 0 0 Jul Jan Feb Mar Apr May Jun Aug Sep Oct Nov Dec Months redraws % Clients

  35. 2001 2002 2004 1999 Quality Assurance: ISO9001:1994 Transition: ISO 9001:1994  ISO 9001:2000 + ISO 14001:1996 Integrated Management System: ISO 9001:2000 ISO 14001:1996 Balanced Scorecard Approach Fleury’s IMS indicators/BSC metrics: From Operation to Management

  36. The future of ISO and Quality Indicators in the Lab: Fleury Diagnostics’ perspective • Promote the continual improvement of the set of indicators • Supply information to guide strategic decisions and strategic planning • Bring clear and measurable gains to the company – from market share to patient satisfaction • Contribute to the sustainability of the Healthcare System • Provide measurements to develop the best practices for patient safety • Promote sustainable development (Financial + Social + Environmental) • Integrate certification and accreditation processes and systems through ISO15189:2003 Brazil: ISO 9001 certification  ISO 15189 accreditation USA: ISO 15189 accreditation ISO 9001 certification

  37. The future of ISO and Quality Indicators: ISO’s Perspective (2005-2010) • Developing a consistent and multi-sector collection of globally relevant international standards • Ensuring the involvement of stakeholders • Raising the awareness and capacity of developing countries • Being open to partnerships for the efficient development of international standards • Promoting the use of voluntary standards as an alternative or as a support to technical regulations • Being the recognized provider of international standards and guides relating to conformity assessment • Providing efficient procedures and tools for the development of a coherent and complete range of deliverables Source: ISO Strategic Plan 2005-2010

  38. Thank you! rogerio.rabelo@fleury.com.br Tel: +55-11-5014-7637 www.fleury.com.br

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