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What are the benefits of QMS for a fertility centre and how do we measure them
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
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
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)
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
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
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
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
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
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)
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