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.

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

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

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

8. Activities
continuously improve
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