2/23/2021 1 1 Introduction Laboratory Quality Management System 2 Standards Organizations ISO International Organization for Standardization Guidance for quality in manufacturing and service industries Broad applicability; used by many kinds of organizations Uses consensus process in developing standards Introduction Laboratory Quality Management System Introduction Laboratory Quality Management System 3 CONFORMITY ASSESSMENT STRUCTURE End Users - Consumers - Industry - Professionals Laboratories, Testing & Calibration CB’s Management Systems Cert. CB’s Inspection & Product Cert. PCB’s Personnel Certification Accreditation Bodies ISO/IEC IAF/ILAC, Regional Accred. IPC, IQNET 2 3 1 ISO/IEC 17025, ISO 15189 ISO/IEC 17020 ISO/IEC 17065 ISOIEC 17021 ISO/IEC 17024 ISO 17011 3
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2/23/2021
1
1Introduction Laboratory Quality Management System
2
Standards OrganizationsISO
International Organization for Standardization
Guidance for quality in manufacturing and service
industries
Broad applicability; used by many kinds of
organizationsUses consensus process in
developing standards
Introduction Laboratory Quality Management System
Introduction Laboratory Quality Management System 3
CONFORMITY ASSESSMENT STRUCTURE
End Users - Consumers - Industry - Professionals
Laboratories,Testing &
Calibration
CB’s Management Systems Cert.
CB’s Inspection & Product
Cert.
PCB’s Personnel
Certification
Accreditation Bodies
ISO/IECIAF/ILAC,
Regional Accred.
IPC,IQNET
2
3
1
ISO/IEC 17025, ISO 15189
ISO/IEC 17020ISO/IEC 17065
ISOIEC 17021 ISO/IEC 17024
ISO 17011
3
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Organization Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Occurrence Management Assessment
Process Improvement
Customer Service
Facilities &
Safety
The Quality Management System
Introduction Laboratory Quality Management System
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What is Quality?
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Achieving a 99% level of quality
means
accepting a 1% error rate1%
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In France a 1% error ratewould mean everyday
14 minutes without water or electricity 50,000 parcels lost by postal services 22 newborns falling from
midwives’ hands 600,000 lunches contaminated
by bacteria 3 bad landings at Orly Paris airport
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Result: 1% failure
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Essential to all aspects of industry are laboratory results that are
accurate,
reliable, and
timely
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Laboratory errors cost in
time
personneleffort
client outcomes
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How do we achieve excellent performance in the laboratory?
Organization Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Occurrence Management
Assessment
Process Improvement
Customer Service
Facilities &
Safety
Introduction Laboratory Quality Management System
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Quality Management System Definition
Coordinated activities to direct and control an organization with regard to quality.
All aspects of the laboratory operation need to be addressed to assure
quality; this constitutes a quality management system.
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Complexity of a Laboratory System
•Data & Laboratory Management•Safety•Customer Service
Client PrepSample Collection
Sample Receipt and Accessioning
Sample TransportQuality Control
Testing
Record Keeping
Reporting
Personnel CompetencyTest Evaluations
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Path of WorkflowTHE CUSTOMER Test selection Sample Collection
Sample Transport
Laboratory Analysis Examination Phase
Report CreationReport Transport
Preexamination Phase
Result Interpretation Postexamination Phase
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WHY is the Path of Workflow essential to consider in laboratories?
The entire process of managing a sample must be considered: the beginning: sample collection
the end: reporting and saving of results
all processes in between.
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Laboratory tests are influenced by laboratory environment knowledgeable staff competent staff reagents and equipment quality control communications process management occurrence management record keeping
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Twelve Quality System Essentials
set of coordinated
activities that function as
building blocks for
quality management
Organization Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Occurrence Management
Assessment
Process Improvement
Customer Service
Facilities &
Safety
Introduction Laboratory Quality Management System
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Organization Personnel Equipment
Purchasing &
Inventory
Process Control
Information Management
Documents&
Records
Occurrence Management
Assessment
Process Improvement
Customer Service
Facilities &
Safety
Path of Workflow
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Organization
Responsibilities, Authorities
CommunicationProvision of
resources
Quality Policy
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Personnelhuman resources job qualifications job descriptionsorientationtrainingcompetency assessmentprofessional development continuing education
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Equipmentacquisition installationvalidationmaintenance calibration troubleshooting service and repair records
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Purchasing and Inventory
vendor qualifications
supplies and reagents
critical services
contract review
inventory management
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Process Control
quality control
sample management
method validation
method verification
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Information Management
confidentiality
requisitions
logs and records
reports
computerized laboratory information systems (LIS)
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Documents Recordscreation collection
revisions and review reviewcontrol and distribution storage
retention
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Occurrence Management
complaintsmistakes and problemsdocumentationroot cause analysisimmediate actionscorrective actionspreventive actions
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Laboratory AssessmentExternal
Proficiency testing (EQA)
Inspections
Accreditations
InternalInternal
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Process Improvementopportunities for improvement (OFIs)
stakeholder feedback
problem resolution
risk assessment
preventive actions
corrective actions
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Customer Service
customer group identification
customer needs
customer feedback
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Facilities and Safetysafe working environment
transport management
security
containment
waste management
laboratory safety
ergonomics
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ImplementingQuality Management
does notguarantee
anERROR-FREE
Laboratory
But it detects errors that may occur and prevents them from recurring