This document discusses the benefits of implementing a Quality Management System (QMS) for a fertility center. It explains that a QMS helps ensure consistency, meet customer needs, and increase efficiency. Benefits are measured through audits, tracking quality actions, and key performance indicators. Tools like Pareto diagrams, control charts, and the PDCA method are used to analyze data. The presentation then discusses Androfert fertility center's experience implementing ISO 9001 certification in 2006. This helped Androfert improve quality of services, comply with regulations, boost its reputation, increase market share and profitability over time. The QMS created a well-organized workflow and focus on continuous improvement.

1. www.excemed.org
IMPROVING THE PATIENT’S LIFE
THROUGH
MEDICAL EDUCATION
What are the benefits of QMS for a fertility centre and how
do we measure them
S. Esteves
Brazil
23-24 January 2015 - Hamburg, Germany

2. Learning objectives
At the completion of this presentation,
participants should be able to:
• Understand how an organization could
benefit from establishing an effective QMS
• Learn how to measure quality as per QMS
perspective
• Learn what we achieved at Androfert after
having implemented ISO 9001

3. http://www.androfert.com.br/review

4. Know your customers and define the processes to
meet their expectations
Define goals and objectives, so that processes and
procedures help you achieve them
Offer resources and infrastructure to fulfill
objectives
Systematically correct and prevent non-conformities
Measure your performance and your customers’
satisfaction periodically
Make changes, adjustments, and improvements
based on measured results and not on assumptions
Essentials of a successful QMS

5. ISO 9001: Conceptual Model

6. Customers are not only our patients…
• Doctors who use our services
• Our employees
• Suppliers
• People in our community
• Regulatory authorities

7. Adoption of QMS is a strategic decision of a
fertility center
Influenced by:
 Regulatory directives
 Concerns about quality of services
Effectiveness & efficiency
Safety
Customer requirements/satisfaction

8. Worldwide tendency is IVF guidelines
including QMS become mandatory
Australia Code of practice for assisted
reproductive technology units,
Reproductive Technology Accreditation
Committee (RTAC)
Brazil RDC 33 and 23, National Agency of
Sanitary Surveillance (ANVISA)
European
Union
EU directive 2004/23/EG, 2006/17/EG,
2006/86/EG
South Africa National Health Act 61/2003; Human
Tissue Act
USA CLIA for Andrology laboratories; FDA
for cryobiology

9. What regulatory bodies ask for
Document control system
Personnel training
Periodic audits
Procedures for detection, registration,
correction and prevention of errors and non-
conformities
Compliance with biosafety regulations
System to evaluate and control materials and
equipment

10. Concerns about quality of services
Dancet et al.
Hum Reprod 2013
0% 50% 100%
Doctors &
embryologists
Nurses
Patients
Safety
Effectiveness
Patient-
centeredness
How stakeholders value the top 3 quality
dimensions of infertility care

11. QM focuses on customer requirements
and satisfaction
Lack of psychological support and
poor quality of service ~60%
treatment discontinuation
22 studies sampling 21,453
patients from 8 countries

12. A QMS will ensure that two important
requirements are met…
1. Customer’s requirements
Confidence in the ability of the center to
deliver the desired service consistently
meeting their needs and expectations
2. Fertility center’s requirements
Both internally and externally, and at an
optimum cost with the efficient use of the
available resources (materials, human,
technology and information)

13. A powerful “wedge”

14. Key points (1)
The benefits are…
1. Enables fertility center to provide consistency
in terms of methods, materials, equipment,
etc.
Safety and effectiveness
2. Ensures that services conform with customers'
needs and requirements
Customer-centeredness
3. Allows an increase in efficiency
Profitability

15. QMS benefits can only be achieved if
evidence is provided

16. How to get information
Internal and external audits
Registration of quality actions
Non-conformities, preventive
actions, improvement actions,
complaints
Satisfaction surveys/questionnaires
QC and QA reports
Key performance indicators
MainTools

17. 17

18. How to measure & analyze
Pareto diagram
Diagram of cause and effect
Control chart
Histogram
Flowchart
Quality
Tools
PDCA
Balanced score card (BSC)
Six sigma
Quality
Methods

19. Pareto Diagram
Prioritize problems to be solved

20. Diagram of cause and effect
Prioritize factors that may cause undesired effect

21. Control chart
Monitor the stability or instability of a process

22. 0
2
4
6
8
10
12
Q1
2010
Q2
2010
Q3
2010
Q4
2010
Q1
2011
Q2
2011
Q3
2011
Q4
2011
Q1
2012
Q2
2012
Q3
2012
Q4
2012
Number of non-conformities
Histogram
Distribute data and shows how a given
process varies

23. Histogram

24. Flow chart
Visualize a process and identify improvement
opportunities

25. How to measure & analyze
Pareto diagram
Diagram of cause and effect
Control chart
Histogram
Flowchart
Quality
Tools
PDCA
Balanced score card (BSC)
Six sigma
Quality
Methods

26. PDCA
Method to monitor, correct and
improve a process

27. Category Metric Target Status
Customer
satisfaction
Repeat customer % IVF drop-out <50% 50%
Service % IVF cycles
w/complaints
<5% 2%
Financial
No. IVF cycles % Annual growth >5% 8%
No. tests Andrology lab % Annual growth +/- 10% 8%
Payment rate
sperm/embryo bank
% clients in debt
<35% 40%
Employee
satisfaction
Turnover 2-yr. period <5% 9%
Absenteeism Days year/employee 4 2
Quality
ISO recertification approval
Non-conformities No. year reduction -10%
Balanced Score Card
Provide a hierarchized view of the organization’s
performance management system

28. 6 Sigma
Provides a general map that helps to reduce
variability

29. Key points (2)
Measurement is carried out by…
Getting information
Audits, registration of quality actions, data
collection of (key performance indicators)
Applying quality tools
Pareto diagram, diagram of cause/effect,
histogram, flow chart
Integrating quality tools with quality methods
PDCA, BSC & 6 Sigma

30. 1996 – Androfert
Foundation
2000 – IVF Program
started
2006 – Started QMS implementation
2010 – ISO Certification
2013 – Recertification
What we achieved…

31. Main reasons we implemented QMS
Core reasons
Concerns about quality of services
Regulatory directive
Beyond the core
Image and reputation
Customer satisfaction
Market share (customer
retention/acquisition)
Profitability

32. Core Reasons Achieved
•Quality of services
Certified and recertified with
“zero” non-conformities during
external auditing
First in Brazil to obtain ISO
9001 certification
•Full compliance with
regulatory authorities

33. QualityofLaboratories

34. Image and Reputation
Recognized as “Model”
fertility center by
national government
agency
• Germinative cell and
tissue division; ANVISA
• Training center for
ANVISA inspectors
(Brazilian Germinative
Tissue Directive)

35. 0
5
10
15
20
25
Total number of doctors associated
to the IVF program
Market share
ISO 9001

36. 0
2
4
6
8
10
12
14
16
18
20
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Percentgrowthperyear
Year
IVF Program
Profitability

37. And more…
Set direction & met customers’
expectations
Improved process control & reduced
wastage
Created a proper documentation system
Facilitated training
Involved staff & raised morale
Improved communication & feed-back with
all team members

38. Key points (3)
What we achieved was …
 A very well-organized workflow
 Excellence in service provided
 Focus on customers needs/satisfaction
 Increased operational efficiency and
profitability
 Continuous improvement