Clinica di Oncoematologia PediatricaAzienda Ospedaliera–University of Padova-Italy

Padova Cord Blood Bank&

Stem Cell Processing Laboratory

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�Need for a Quality System

ISO 9000

Why ISO 9000 Certification?

�Obligation for the Network of Italian Cord Blood Banks

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The ISO 9000 family of standards represents an international consensus on good quality management practices.

It consists of standards and guidelines relating to quality management systems and related supporting standards.

It provides a set of standardized requirements for a quality management system regardless of what the user organization does.

What is ISO 9001 Quality System ?

ISO 9000

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ISO 9001:2008 is the current version of the Standard

ISO 9000

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To achieve ISO Certification an independent quality system Certification Body has to be engaged.

ISO 9000

ISO 9001 Certification

It is determined by evaluation of the written information (Quality Manual) provided by the applicant and by on-site inspection.

Certified organizations are inspected at regular intervals:

Every 3 year Certification Renewal Each year Surveillance Audit

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Certification is based only on standards that have requirements for quality system.

All requirements of ISO 9000 International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

ISO / FACT

Certification vs Accreditation

Certification

Accreditation Accreditation is based on standards that have, beside requirements for quality system, also requirements for quality management and technical competence.

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CONSULTANT QUALITY GROUP

ManagementReview

Monitoring and Measurement

Documentation

Responsibilities

Processes

ISO 9000

PDCBB QMS Implementation

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should meet customer requirements and strive to exceed customer expectations

leaders establish unity of purpose and direction of the organization

people of all levels are the essenceof an organization

should be a permanent objectiveof the organization

a desired result is achieved more efficiently when

activities and related resourcesare managed as a process

ISO 9000

Customer focus

Leadership

Involvement of people

Process approach

Quality Management Principles

Continual improvement

9PROCESSES INTERACTIONS Padova Cord Blood Bank

ISO 9000 Process Approach

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POLICIES

WORK INSTRUCTIONS

SOPs

FORMS, WORKSHEETS, CHECKLISTS

QM

Document Development

Document Hierarchy

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PDCBB ISO 9000 Documentation

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Plan:Define, Prepare, Document

Do:Implement the process

Check:Measure & Compare

Act:Evaluate

and correct

Quality Assurance System

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� Customer satisfaction

� Internal audits

� Processes

� Product

� Analysis of data

� Improvement

Monitoring and Measurement

QM Assessment

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� At least one indicator per process should be determined

� Ideally all phases of the path of workflow should be regularly monitored, but this can be impractical

� They measure the degree to which any process deviates from its goal

� Performance on selected indicators is to be reported periodically

Indicators of Quality

QM Assessment

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� Personnel training / performance

� Environmental monitoring results

� Corrective actions status

� Preventive actions status

� Nonconformities number

� Sterility test results

� Cell Recovery results

� …and more

Indicators: some examples

QM Assessment

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• Transplant Centres• Donor Registries

Customer Satisfaction

Who are our customers?

PATIENTS!

QM Assessment

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PDCBB Survey Result

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20

0

0

#CB units

59 %Excellent

41 %Good

0 %Fair

0 %Poor

%Score

Customer Satisfaction

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• Top management reviews the organization’s QMS at planned intervals to ensure suitability, adequacy and effectiveness.

QM Review

Management Review

• Review shall include assessing opportunities for improvement and the need for changes to QMS including the quality policy and quality objectives.

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• Results of audits

• Customer feedback

• Process performance and product conformity

• Status of preventive and corrective actions

• Follow-up actions from previous management review

• Changes that could affect the QMS

• Recommendations for improvement

QM Review

Review input

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• Improvement of the effectiveness of QMS and its processes

• Improvement of product related to customer requirements

• Resource needs

QM Review

Review output

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� Improving personnel education

� Obtaining public and private funds

� Purchasing and/or replacing equipment

� Establishing a new path of workflow in the lab

� Introducing regular environmental monitoring

How we try to achieve it:

Continual Improvement

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Quality Level

Time

Quality control(Internal /External audits)

Contin

ual im

provem

ent

• PLAN• DO• CHECK• ACT

Quality Assurance System

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Organizational chart:

ISO/FACT

What has been changed for FACT JACIE Accreditation?

ISO 9000 does not define personnel requirements as FACT-JACIE standards.

Who can be “Director” for ISO 9000 could not be Director” for FACT-JACIE standards.

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Development of new procedures for:

ISO/FACT

What else?

• Work Environment • Qualification and Validation• Labeling• Disaster plan

Addition to SOP format of:

• Acceptable end-points and expected results • Reference section

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� ISO 9000 showed to be an excellent Quality System for a stem cell processing laboratory.

� Process approach allows an ongoing control of the linked activities.

� Annual surveillance audit helps to maintain and improve quality.

� For FACT-JACIE and FACT NetCord Accreditations little modifications are required.

� Continual improvement becomes mandatory.

Conclusions

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