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How to implement QMS in a Fertility Centre
1. Sandro C. Esteves
ANDROFERT, BRAZIL
L6: How to implement
QMS in a fertility center
IVF Preceptorship Hamburg, 4-5 July 2014
QMS in the Fertility Centre
ISO 9001:2008
2. Learning objectives
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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 9001:2008
at Androfert and how to adapt what we did
to your own center
3. o It varies from person to
person, and it’s
influenced by feelings
o Despite being a relative
concept, it cannot be
established in a vacuum
o Always relative to a set
of requirements
Quality is
subjective…
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4. Quality is how well the output of
our processes comply with a set
of pre-defined requirements
Process = Any activity or set of activities that
uses resources to transform raw material,
supplies and labor (inputs) into products or
services (outputs)
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5. A set of coordinated activities to
direct and control an
organization to continuously
improve the effectiveness and
efficiency of its performance
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7. QMS - ISO 9001:2008
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
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8. ISO 9001:2008 - 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
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9. Key points (1)
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
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10. How to
implement
QMS in a
fertility
center
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11. 1. Create your mission statement
Define who your clients areWHO
Define what services you provideWHAT
Define your methods, philosophy,
objectives, etc.
HOW
Our mission is to help couples with conception
difficulties become parents, especially when the
difficulty is partially or totally related to men, through
counseling, diagnosis and treatment, offering
personalized professional service of excellence, and
using all available technologic resources
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12. 2. Define your QM focus
Brief, simple and direct statements that
define 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 you monitor your quality objectives
(tools to check if your objectives, and
therefore your policies are being achieved)
Quality
Indicators
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14. 3. Describe your processes and
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
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16. 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
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17. 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
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18. 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
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19. Document Control
Quality Manual
– Describe document control system
– Documents must be reviewed and
authorized
– Audit & update quality documents
annually
– SOP for retention and storage of records
– SOP for control of archive documentation
Technical Manual
– Master list of documents and retention
times
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21. Clinical Needs
Determine
tests/procedures
Write SOP
Does it provide
information for
clinical decision?
What does the
doctor need to
know?
Designing SOPs
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22. Designing a SOP - Example
How can I avoid
unnecessary
surgical sperm
retrieval in men
with NOA?
Semen analysis
at day of sperm
retrieval
Presence of
sperm for ICSI
What does the
doctor need to
know?
Determine test
Lab SOP with
post-analytical
info for clinical
decision
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23. How can I avoid
unnecessary
surgical sperm
retrieval in men
with NOA?
Semen analysis
at sperm retrieval
day
Presence of
sperm for ICSI
Does SOP provide solution for
panic/alert values?
Panic value: No
sperm
What to do next?
eg.: Centrifugation
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25. Key points (2)
1. Explain why the organization exists
2. Create quality policies to generate quality
objectives; they serve as a general
framework for action
3. Define all processes needed to meet a
desired outcome
Design workable SOPs
Implement, control (verify conformity) and
improve (update) SOPs
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26. 4. Training
personnel
Getting to know each
other
each sector presents who
they are, what and how they
work
Interdepartmental
observations
provides a realistic view
daily work activities
Internalizing ethical and
moral values
understand their individual
roles and importance within
the organization
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28. 4. Training personnel (cont.)
Initial and recurrent training clearly outlined
SOPs are key elements
Staff performance periodically evaluated
Feedback given
Continual training
program established
cover both new
training as well as
reviewing concepts
and procedures, to
guarantee
internalization
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29. Personnel & Training
Summary
• Job descriptions
• Personnel policies
• Induction training
• Professional qualifications
• Competency testing
• Responsibilities clearly defined
• Training/ retraining
• Informed of ethical issues/moral values
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30. Infrastructure
Entire system of facilities, equipment, and
services that a fertility center needs in
order to function
Buildings
Workspaces
Equipment
hardware & software
Support services
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31. 5. Register quality actions
Actions taken to improve the
service provided
Improvement
Actions
Actions taken to avoid a potential
non-conformity before it actually
happen
Preventive
Actions
Actions taken after detecting a non-
conformity to correct it
Corrective
Actions
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32. ANDROFERT
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Non-conformities
Every deviation
from what is
established.
Identify
inconsistencies,
weaknesses,
and
improvement
opportunities
33. Implement a
culture of reporting
NC, preventive
action,
improvement
opportunity
Electronic-based
records
Data collection more
uniform
5. Registering (cont.)
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34. 6. Auditing
Verify conformity
Main
Objective
Processes, Procedures,
Documents and Records
Types
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36. 7. Information
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.
Mainobjectives
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38. 8. 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
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40. 8. Continuous improvement (cont.)
Fabiola Bento, MBA
Quality Manager, ANDROFERT
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
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41. Key points (3)
How we implemented
1. Taught the ISO standard to the whole team
2. Engaged the management team so that their
work reflected the new concept and was used
as an example for the rest of the team
3. Identified the processes and procedures
involved in the realization of our service
4. Standardized all procedures necessary to
offer the service we provided, writing SOPs
and training our team
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42. 5. Created ways to control (internal auditing) and
guarantee SOPs were being followed without
variations
6. Defined and monitored key performance
indicators to improve the quality of services
provided
7. Formally documented the implemented
system
8. We were surveyed and ISO certified
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Key points (3)
How we implemented
43. “The real voyage of discovery
consists not in seeking new
landscapes, but in having new
eyes.”
Marcel Proust
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Editor's Notes
Quality indicators are measurable. They are used to quantify and evaluate the organization’s success. They also measure how much progress you’ve made relative to the objectives you wish to achieve.
They are critical to make improvements and support decision making.
