introduction to quality management systems
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Introduction to Quality Management Systems
Prof dr Elisabeth Dequeker
UZ-KULeuven, Belgium
1prof dr E Dequeker
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Agenda
• Assessing Quality in a PGD laboratory
• Quality standards and accreditation
• Quality Management Systems
2prof dr E Dequeker E Dequeker - KULeuven
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sportive, capacity of engine, design, tinted windows
reliable
pain control
Quality ?
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Preimplantation genetic diagnosis
• Genetic testing of embryos, to assist couples with
high risk of transmitting a severe genetic disease
• The result of the analysis is expected to be correct,
reliable and in time
4prof dr E Dequeker E Dequeker - KULeuven
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prof dr E Dequeker
DNA
Assessing Quality PGD laboratory
& Report
pre- / post-counselling
Interpretation
Genotype Analysis
Embryo biopsy
5E Dequeker - KULeuven
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A white mother has given birth to black twins, following a laboratory mix-up.
Juli 2002
Assessing Quality PGD laboratory
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prof dr E Dequeker
DNA PCR Analysis Report
External Quality Assessment scheme
1/ Evaluation of the practical analysis accurate genotyping
2/ Evaluation of the data interpretation (written reports)
Clinical significance of the detected mutations
Residual risk if appropriate
Recommendations for genetic counseling, prenatal diagnosis, …
Assessing Quality PGD laboratory
7E Dequeker - KULeuven
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Eur J Hum Gen 1998, 6, 165-175
Assessing Quality PGD laboratory
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prof dr E Dequeker
CF EQA schemeParticipating molecular (genetic) diagnostic laboratories
1996: n=136 2010 : n >220
Participants from 34 different countries (including US, Australia)
Dequeker et al. , Nature Reviews Genetics, 2001, 2, 717-723
Assessing Quality PGD laboratory
9E Dequeker - KULeuven
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Assessing Quality PGD laboratory
Eur J Hum Gen 2008, 16, 290-29910prof dr E Dequeker E Dequeker - KULeuven
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Agenda
• Assessing Quality in a PGD laboratory
• Quality standards and accreditation
• Quality Management Systems
11prof dr E Dequeker E Dequeker - KULeuven
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prof dr E Dequeker
ISO 9001Quality Management systems - Requirements
ISO/IEC 17025General requirements for the competence of testing and calibrationlaboratories
ISO/IEC 15189 Medical laboratories – Particular requirements for quality and competence
Quality Standards and accreditation
www.iso.org
12E Dequeker - KULeuven
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prof dr E Dequeker
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International Organization for Standardization - ISO
ISO 15189 international accreditation standard for medical laboratories
1/ Quality management system (QMS) Procedures and quality manual Document control Non-conformities, corrective and preventive actions Internal audits and management review
2/ Technical competence Continuous training of personnel Calibration and maintenance of equipment Validation procedures Internal and external quality control
www.iso.org
Quality Standards and accreditation
13E Dequeker - KULeuven
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prof dr E Dequeker
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Organisation for Economic Co-operation and Development -OECD
OECD guidelines for quality assurance in molecular genetic testing (MGT), 2007
Directrices de la OECD para la gestión de la calidad de los estudios genéticos moleculares
Quality assurance and accreditation
External Quality Assessment (EQA) schemes
Result reporting
Training for laboratory personnel
www.oecd.org
Quality Standards and accreditation
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prof dr E Dequeker
ISO
900
1
ISO
170
25
ISO
151
89
Quality Standards and accreditation
15E Dequeker - KULeuven
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prof dr E Dequeker
ISO
900
1
ISO
170
25
ISO
151
89
accreditation
certification
Quality Standards and accreditation
16E Dequeker - KULeuven
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prof dr E Dequeker
Certification
Example : Courier companyDHL deliver a package in 5 daysTNT deliver a package in 2 days
Procedure by which a third party gives writtenassurance that a product, process or service conforms to specific requirements
ISO 9000, 2000 Quality management systems – fundamentals and vocabulary
Process Management = requirements for quality management system e.g. ISO 9001
Quality Standards and accreditation
17E Dequeker - KULeuven
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prof dr E Dequeker
A procedure by which an authoritive body gives formalrecognition that a body or person is competent to carry out specific tasks
Accreditation
ISO 9000, 2000 Quality management systems – fundamentals and vocabulary
Quality Management = requirements for quality management systems + technical & analytical competence requirements
e.g.,ISO 17025 and ISO 15189
Quality Standards and accreditation
18E Dequeker - KULeuven
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Quality Standards and accreditation
E Dequeker (in press 2009) Quality Management Systems and Accreditation In: Kristofferson U,Schmidtke J, Cassiman JJ (ed) Quality Issues in Clinical Genetic Services. Springer PressHeidelberg/New York
Example : Difference between accreditation and certification
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prof dr E Dequeker
Estonia
Czech Republic
Belgium
Austria
Croatia U.K.
Finland
Italy The Netherlands
Spain Switzerland
Denmark
Portugal
Quality Standards and accreditation
20E Dequeker - KULeuven
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prof dr E Dequeker
MLA - Signatories
www.europeanwww.european--accreditation.orgaccreditation.org
Quality Standards and accreditation
21E Dequeker - KULeuven
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Quality Standards and accreditation
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Preimplantation genetic diagnosis
• Genetic testing of embryos, to assist couples with
high risk of transmitting a severe genetic disease
• The result of the analysis is expected to be correct,
reliable and in time
23prof dr E Dequeker E Dequeker - KULeuven
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Why accreditation?
• Benefit through better processes and quality of results (QM process + technical and analytical process)
• Accreditation is a good way to demonstrate competence
• Accreditation is a tool world-wide to recognize laboratories
• In some countries accreditation is mandatory or will be mandatory in the future
• More and more international pressure, attention to quality assurance and accreditation (see OECD guideline for Molecular Genetic Testing laboratories June 2007)
Quality Standards and accreditation
24prof dr E Dequeker E Dequeker - KULeuven
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Agenda
• Assessing Quality in a PGD laboratory
• Quality standards and accreditation
• Quality Management Systems
25prof dr E Dequeker E Dequeker - KULeuven
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Quality Management Systems
• Qualified personnel – continuous education
• Standard operating procedures (SOPs)
• Document control
• Equipment (maintenance and calibrated)
• Non conformities, corrective en preventive actions
• Internal audit
• Quality Manual
• Validation of tests
• Management review
26prof dr E Dequeker E Dequeker - KULeuven
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Quality System
Patient
ReportInterpretationn
TEST PROCESSESRequest
Patient
PersonnelTraining
Equipment and accommodationValidation
RESOURCES DOCUMENTS
Document controlQuality manual and policy
Standard operating proceduresLog books
Non-conformities
Internal and external auditManagement review
Preventive actions
MANAGEMENTORGANISATION
Corrective actions
CONTINUAL IMPROVEMENT AND QUALITY ASSURANCE
SuppliersContractsReferral laboratoriesAdvisory services
EXTERNAL SERVICES
External quality assessmentInternal quality controlCalibration
Batch controlReagents inventory
Quality Management Systems
by S Berwouts
27prof dr E Dequeker E Dequeker - KULeuven
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prof dr E Dequeker ISO 15189 : 200728E Dequeker - KULeuven
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Different activities in a PGD lab
Elements of ISO 15189
“Quality Management system” ISO 15189 accreditation
30prof dr E Dequeker E Dequeker - KULeuven