How to implement QMS in a fertility centre
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Sandro Esteves presented on how to implement a Quality Management System (QMS) based on ISO 9001 in a fertility center. He discussed 9 key steps: 1) appointing a quality manager, 2) establishing the mission, policies and objectives, 3) identifying processes and standardizing procedures, 4) registering quality actions, 5) auditing to ensure compliance, 6) monitoring performance, 7) continual improvement activities, 8) formally documenting the system, and 9) undergoing certification. The presentation provided details on how Esteves' clinic, ANDROFERT, successfully implemented these steps to achieve ISO 9001 certification and continuously improve their quality of care.
How to implement QMS in a fertility centre
- 1. www.excemed.org IMPROVING THE PATIENT’S LIFE THROUGH MEDICAL EDUCATION How to implement QMS in a fertility centre S. Esteves Brazil Hamburg, 23-24 January - 2015
- 2. Sandro Esteves ANDROFERT - Andrology & Human Reproduction Clinic Campinas, Sao Paulo, Brazil ANDROFERT androfert.com.br ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTION S ESTEVES, 2 2015 January ANDROFERT
- 3. Learning objectives At the completion of this presentation, participants should be able to: • Understand what QMS stand for • Understand the basic concepts of ISO 9001 as a model for QMS to fertility centers • Learn how we implemented ISO 9001 at Androfert and how to adapt what we did
- 5. It varies from person to person, and it’s influenced by feelings Despite being a relative concept, it cannot be established in a vacuum Always relative to a set of requirements Quality is subjective…
- 6. Process = Any activity or set of activities that uses resources to transform raw material, supplies and labor (inputs) into products or services (outputs) Quality is how well the output of our processes comply with a set of pre-defined requirements
- 7. A set of coordinated activities to direct and control an organization to continuously improve the effectiveness and efficiency of its performance
- 9. QMS - ISO 9001 Determine needs and expectations of customers and others (legislation, professional societies, etc.) Mission Establish a quality policy, quality objectives, and quality indicators for the organization QM focus Determine processes/procedures to achieve the quality objectives; Identify and provide necessary resources Process Determine means to prevent nonconformities (NC) (variation) and eliminate their causes; Register quality actions; Verify compliance (auditing) NC; Registering; Auditing Establish and apply methods to measure effectiveness/efficiency of each process Monitoring Establish and implement a process that involves all personnel for continual improvement Continual improvement Say what you do and what your requirements are Show how you do Show how you ensure you follow what you say you do Show what you do to improve what you do
- 10. ISO 9001- QMS Determine needs and expectations of customers and others (legislation, professional societies, etc.) Mission Establish a quality policy, quality objectives, and quality indicators for the organization QM focus Determine processes/procedures to achieve the quality objectives; Identify and provide necessary resources Process Determine means to prevent nonconformities (NC) (variation) and eliminate their causes; Register quality actions; Verify compliance NC; Registering; Auditing Establish and apply methods to measure effectiveness/efficiency of each process Monitoring Establish and implement a process that involves all personnel for continual improvement Continual improvement
- 11. Quality is relative to a set of requirements how well the output of our processes comply with pre-defined requirements QMS: coordinated activities to direct and control an organization to continuously improve the effectiveness and efficiency of its performance expresses organizational structure, policies, procedures, processes and resources needed to implement quality management Key points (1)
- 12. How to implement QMS in a fertility center ANDROFERT, Campinas - BRAZIL
- 13. Fabiola Bento, MBE Quality Manager, ANDROFERT Appoint a Quality Manager Establish unity of purpose and direction of the internal environment Create an environment where people are fully involved in achieving the organization’s objectives How we implemented: Step 1
- 14. Step 2 Learned and taught the ISO standard to the whole team Engaged the management team so that their work reflected the new concept and was used as an example for the rest of the team How we implemented: Step 1 Quality Manager Defined the reason we existed Defined our quality requirements
- 15. Step 2: Mission Statement Defined who our clients were WHO Defined what services we provided WHAT Defined our methods, philosophy, objectives, etc. HOW Our mission is to offer counseling, diagnostic and treatment services to men with fertility problems, and offer our associate doctors the necessary infrastructure and laboratorial services to perform assisted reproductive treatments
- 16. Step 2: Quality Management Focus Brief, simple and direct statements that defined top management’s commitment to quality (general quality orientation and basic intentions) Quality Policy
- 17. QM Focus
- 18. Step 2: Quality Management Focus Brief, simple and direct statements that defined top management’s commitment to quality (general quality orientation and basic intentions) Quality Policy Goals of each quality policy (they have to be measurable) Quality Objectives How to monitor quality objectives (tools to check if objectives, and therefore policies are being achieved) Quality Indicators
- 19. QM Focus
- 20. Identified the processes and procedures involved in the realization of our service Standardized all procedures necessary to offer the service we provided, writing SOPs and training our team How we implemented: Step 3
- 22. Processes vs. procedures Any activity or set of activities that uses resources to transform raw material, supplies and labor (inputs) into products or services (outputs) Process Sequence of steps to execute a task Important for standardization and replication Procedure
- 23. Standard Operating Procedure (SOP) sequence of steps that have been standardized to execute a task, which is used every time a given task is done, to ensure it is done the same way each time Detailed instructions to achieve uniformity on the performance of a specific procedure Usually written and hierarchical, but also expressed as flowcharts or drawings
- 24. Lab SOP key points I. General information: • Name of test or procedure • Principles (goals and general information) II. Pre-analytic information: • Patient instruction for test/procedure preparation • Specimen collection instructions • Specimen labeling, transport, referral • Specimen acceptability (including rejection criteria) III. Analytic information: • Equipment, materials and reagents • Conditions required (e.g. laminar flow cabinet) • Instrument calibration and verification • Quality control (negative/positive control if required) • Step-by-step procedure description • Assay/procedure performance limitations • Troubleshooting IV. Post-analytic information: • Calculations (if required) • Normal ranges (reference intervals or expected results) • Policy for handling alert or panic values • Report • References
- 25. Top 5 reasons why fertility centers need SOPs 1. Repetitive highly-complex critically important tasks 2. Variation must be controlled 3. More than one person could perform the same task 4. Safety risks are present 5. Quality control needs to be ensured
- 26. Personnel & Training • Job descriptions • Professional qualifications • Responsibilities clearly defined • Personnel policies –Ethical issues and moral values • Induction training and retraining • Competency assessment
- 27. Training personnel 1.Getting to know each other Each sector presents who they are, what and how they work 2.Interdepartmental observations Provide a realistic view daily work activities 3.Internalizing ethical and moral values Understand their individual roles and importance within the organization
- 28. Training personnel in QMS (cont.)
- 29. Training personnel (cont.) Initial & recurrent training clearly outlined SOPs are key elements Staff performance periodically evaluated Feedback given Continual training program established cover both new training and reviewing concepts and procedures, to guarantee internalization
- 30. Assessment whether infrastructure is adequate Entire system of facilities, equipment, and services that a fertility center needs in order to function Buildings Workspaces Equipment hardware & software Support services
- 31. Key points (2) 1. Explained why the organization exists 2. Created quality policies to generate quality objectives; they serve as a general framework for action 3. Defined all processes and procedures needed to meet a desired outcome Personnel training Infrastructure How we implemented: Steps 1-3
- 32. QMS - ISO 9001 Determine needs and expectations of customers and others (legislation, professional societies, etc.) Mission Establish a quality policy, quality objectives, and quality indicators for the organization QM focus Determine processes/procedures to achieve the quality objectives; Identify and provide necessary resources Process Determine means to prevent nonconformities (NC) (variation) and eliminate their causes; Register quality actions; Verify compliance (auditing) NC; Registering; Auditing Establish and apply methods to measure effectiveness/efficiency of each process Monitoring Establish and implement a process that involves all personnel for continual improvement Continual improvement Show how you ensure you follow what you say you do
- 33. Step 4: Register quality actions Actions taken to improve the service provided Improvement Actions Actions taken to correct a non-conformity after detecting it Corrective Actions Actions taken to avoid a potential non- conformity before it actually happen Preventive Actions
- 34. 4. Registering: Non-conformities Every deviation from what is established Identify inconsistencies, weaknesses & improvement opportunities
- 35. Implement a culture of reporting NC, preventive action, improvement opportunity Electronic-based records Data collection more uniform 4. Registering (cont.)
- 36. Step 5: Auditing Verify conformity Main Objective Processes, Procedures, Documents and Records Types
- 38. Step 6: Monitoring Quantify and evaluate the organization’s success Measure how much progress you’ve made relative to the objectives you wish to achieve Critical to make improvements and support decision making Main objectives
- 40. Step 7: Continual Improvement Set of recurring activities carried out to enhance the ability to meet requirements • Audits (internal & external) • Self-assessments • Management reviews • Implement corrective and preventive actions • Improvement group
- 42. Key points (3) How we implemented 1. Appointed a Quality Manager Learned and taught the ISO standard to team Engaged the management team 2. Created mission statement defined quality policies and quality objectives Defined what we do and which requirements we have 3. Identified the processes and procedures involved in the realization of our service Standardized all procedures needed to offer the service we provided, writing SOPs and training team
- 43. Key points (3) How we implemented 4. Created a culture of registering quality actions Non-conformities, corrective/preventive/improvement 5. Created ways to control (internal auditing) and guarantee SOPs were being followed without variations 6. Monitored key performance indicators 7. Incorporated activities to improve quality of services provided 8. Formally documented the implemented system
- 44. SOPs Laboratories description Personnel, job descriptions, responsibilities Training program Safety instructions General rules Mission Policies, objectives & indicators Document control system Reviews, auditing, retention How to register and control non-conformities, corrective & preventive actions Auditing system Improvement system Technical manual Clinical and laboratory SOP manual Quality manual Formal QMS documentation
- 45. Key points (3) How we implemented 4. Created a culture of registering quality actions Non-conformities, corrective/preventive/improvement 5. Created ways to control (internal auditing) and guarantee SOPs were being followed without variations 6. Monitored key performance indicators 7. Incorporated activities to improve quality of services provided 8. Formally documented the implemented system 9. We were surveyed and ISO certified
- 46. How to implement QMS in a fertility center
- 47. “The real voyage of discovery consists not in seeking new landscapes, but in having new eyes.” Marcel Proust
- 48. www.excemed.org IMPROVING THE PATIENT’S LIFE THROUGH MEDICAL EDUCATION IVF Preceptorship Hamburg Hamburg, 4-5 July - 2014