How to implement QMS in a Fertility Centre

Sandro C. Esteves

ANDROFERT, BRAZIL

L6: How to implement QMS in a fertility

center

IVF Preceptorship Hamburg, 4-5 July 2014QMS in the Fertility Centre

ISO 9001:2008

Learning objectives

ANDROFERTandrofert.com.br

ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTIONS ESTEVES, 22014 JULY

ANDROFERT

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

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 issubjective…



ANDROFERT

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)



ANDROFERT

A set of coordinated activities to direct and control an organization to continuously improve the effectiveness and efficiency of its performance



ANDROFERT

Activitiescontinuously improve

performance



ANDROFERT

QMS - ISO 9001:2008Determine 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 improveme

nt



ANDROFERT

ISO 9001:2008 - QMSDetermine 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 improveme

nt

Express

es the org

anizatio

nal

stru

cture

, polic

ies,

proce

dures,

proce

sses a

nd

reso

urces n

eeded to

implement q

uality

management



ANDROFERT

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



ANDROFERT

How to implement QMS in a fertility center



ANDROFERT

1. Create your mission statement

Define who your clients areWHODefine what services you provide

WHAT

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



ANDROFERT

2. Define your QM focusBrief, 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 Objective

s

How you monitor your quality objectives (tools to check if your objectives, and therefore your policies are being achieved)

Quality Indicator

s



ANDROFERT



ANDROFERT

QM

Focu

s

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) P

rocess

Sequence of steps to execute a task

Important for standardization and replication

Pro

ced

ure



ANDROFERT



ANDROFERT

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



ANDROFERT

Top 5 reasons why Fertility Centers need SOPs

1. Repetitive highly-complex critically important tasks

2. Variation must be controlled3. More than one person could

perform the same task4. Safety risks are present5. Quality control needs to be

ensured



ANDROFERT

Lab SOP key pointsI. 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



ANDROFERT

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

documentationTechnical Manual

– Master list of documents and retention times



ANDROFERT

Tech

nic

al M

an

ual



ANDROFERT

Clinical NeedsDetermine

tests/procedures

Write SOP

Does it provide information for

clinical decision?

What does the doctor need

to know?

Designing SOPs



ANDROFERT

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



ANDROFERT

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



ANDROFERT

Clinical decision based on Lab SOP

information

Key points (2)

1. Explain why the organization exists2. 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 SOPsImplement, control (verify

conformity) and improve (update) SOPs



ANDROFERT

4. Training personnelGetting 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



ANDROFERT



ANDROFERT

QM training

4. Training personnel (cont.)

4. Training personnel (cont.)

Initial and recurrent training clearly outlined

SOPs are key elementsStaff performance periodically evaluated

Feedback given

Continual training program established

cover both new training as well as reviewing concepts and procedures, to guarantee internalization



ANDROFERT

Personnel & TrainingSummary

• Job descriptions• Personnel policies• Induction training• Professional qualifications• Competency testing• Responsibilities clearly defined• Training/ retraining• Informed of ethical issues/moral

values



ANDROFERT

Infrastructure

Entire system of facilities, equipment, and services that a fertility center needs in order to function

BuildingsWorkspacesEquipment hardware & software

Support services



ANDROFERT

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



ANDROFERT



ANDROFERT

Non

-con

form

itie

sEvery deviation from what is established.

Identify inconsistencies, weaknesses, and improvement opportunities

Implement a culture of reporting

NC, preventive action, improvement opportunity

Electronic-based records

Data collection more uniform

5. Registering (cont.)



ANDROFERT

6. Auditing

Verify conformity

Main

O

bje

cti

ve

Processes, Procedures, Documents and Records

Typ

es



ANDROFERT



ANDROFERT

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.

Main

ob

jecti

ves



ANDROFERT



ANDROFERT

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



ANDROFERT



ANDROFERT

8. Continuous improvement (cont.)

Fabiola Bento, MBAQuality Manager, ANDROFERT

Quality managerEstablish unity of purpose and direction of the internal environment

Create an environment where people are fully involved in achieving the organization’s objectives



ANDROFERT

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



ANDROFERT

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



ANDROFERT

Key points (3) How we implemented

“The real voyage of discovery consists not in seeking new landscapes, but in having new eyes.”

Marcel Proust


ANDROLOGY AND HUMAN REPRODUCTION CLINIC - REFERRAL CENTER FOR MALE REPRODUCTIONS ESTEVES, 432014 MARCH

ANDROFERT

Health & Medicine

How to implement QMS in a Fertility Centre