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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
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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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