This document discusses Total Quality Management in medical laboratories. It covers key aspects of quality management including defining quality, the core elements of a quality management system, and the seven common tools used in quality control. It also discusses requirements for laboratory accreditation such as establishing quality indicators, documentation, and quality assurance activities like proficiency testing and calibration. The overall goal of quality management in medical laboratories is to provide accurate and reliable test results to customers through an effective quality management system.

1. Total Quality Management in
Medical Laboratories
Gift Ajay Sam
Sr. Demonstrator
TMIH, CMC

2. Quality?
• Philip B Crosby- Quality is free 1979- “The
customer is the one you need to make successful.
You have to learn what they need and give it to
them”.
• Joseph M Juran (Father of Quality Management)-
Juran's Quality Handbook -“Some products give
little or no dissatisfaction; they do what the
producer said they would do. Yet they are not
salable because some competing product has
features that provide greater customer
satisfaction”.

3. Quality?
• David Gravin- 8 dimensions to quality-
– Performance based
– Feature based
– Reliability
– Conformance
– Durability
– Serviceability
– Aesthetics
– Perceived quality

4. “THE DEGREE TO WHICH A SET OF
INHERENT CHARACTERISTICS MEET
REQUIREMENTS”.
ISO 9000; 2005

5. GET IT DONE!
Management?

6. How to get it done?
• Plan- Define course of action toward a
measurable goal.
• Organize- How and How much
• Staff- Who does what
• Lead/ Direct- Do it
• Control- system functions in line with the plan

7. PLAN + ORGANIZE + STAFF + LEAD +
CONTROL = CUSTOMER SATISFACTION
Quality Management

8. Quality Management System- Core
• Customer focus
• Top management initiation
• Involve all staff
• Process oriented approach
• System orientation
• Factual decision making
• Mutually beneficial supplier relationship

9. Key elements of Quality Management
• Documenting and Recording strategies
• Organizational structure (Organogram)
• Staff job descriptions and specific roles
• Equipment/ instruments
• Inventory management systems
• Statistical Process control

10. Quality Assurance and Quality Control
Quality Assurance Quality Control
Management strategy Error detection methodology
Everybody's business
Area specific activity
performed by authorized
staff only

11. The 7 common tools of Quality
Management
• Cause and effect diagram
• Flow charts
• Checklist
• Control chart
• Scatter diagrams
• Pareto analysis
• Histograms

12. 7 tools of QC- Cause & effect diagram
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1. Ishikawa diagram or fish bone diagram.
2. Kaoru Ishikawa 1968.

13. 7 tools of QC- Flow charts
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1. Describe a process.
2. Arrows- flow of
direction.

14. Flow chart example
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15. 7 tools of QC- Checklist
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16. 7 tools of QC- Control charts
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1. Shewhart chart, 1920.
2. Mean value in centre.
3. Upper cut off limits &
lower cut off limits on
either side of mean.
4. 68% of values b/w ±
1SD; 95% of values b/w
±2SD; 99.7% values
b/w ±3 SD.

17. 7 tools of QC- Scatter diagrams
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1. Determine the correlation b/w
events.
2. Shows if a relationship exists
b/w 2 sets of data.

18. 7 tools of QC- Pareto analysis
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1. Joseph M
Juran, 1940.
2. Vilfredo
Pareto- Italian
Economist-
80/20
principle.
3. 20% of work
generate 80%
benefit.

19. Other Advanced Quality Management
strategies
LEAN 6 SIGMA
Toyota production system Motorola corp
Philosophy Metric
5s principle (Seiri, Seiton, Seiso
Sikethu, Shitsuke)
DMAIC
Eliminate waste (Waiting, Over
production, Rejection, Motion,
Processing, Inventory,
Transport)
Variation minimization
LEAN 6 Sigma= Philosophy + Metric

20. International Standards Organization
• Merger b/w ISA (International Federation of
National Standardizing Association, New York
1926) and UNSCC (United Nations Standards
Coordinating Committee, 1944 London)
• ISO set up in 1947 by 67 technical committees
• Firstly called International Standards
Coordinating Association by Americans and
Britons.
• Later on called as ISO derived from the Greek
meaning equal.

21. The Evolution of ISO standards
1 ISO 1: Standard reference temperature for industrial length
measurement
1951
2 ISO 31 (Now ISO 80000) document based on SI, ISO has set
units and how to measure them
1955
3 ISO/ TC 104 Standard on freight containers 1968
4 ISO 9001 family of standards published 1995
5 ISO 14001 environmental management standards published 1996
6 ISO 17025 Standard for testing and calibrating laboratories 1999
7 ISO 15189 Medical laboratories requirement for quality and
competence (From ISO 9001+ISO 17025)
2003
8 ISO/IEC 27001 Management system standard on information
security
2005
9 ISO 26000 Guidance on social responsibility 2010
10 ISO 50001 energy management standard 2011
11 ISO 37001 Anti bribery management systems 2016

22. Medical Laboratory Accreditation
• A process by which an authoritative body
gives formal recognition that an organization
is competent to carry out specific tasks.
• E.g. Joint commission on accreditation of
healthcare organizations (JAHO), National
committee on quality assurance (NCQA),
NABL, CAP.
• India NABL authoritative body for testing and
calibrating laboratories.

23. Accreditation vs Certification
Certification Accreditation
A procedure by which a third
party* gives a written
assurance that a product,
process or service confirms to
specific requirements.
*Third party- A person or a body that is
recognized to be independent of the
laboratory or parent organization.
A procedure by which an
authoritative body gives
formal recognition that a body
or a person is competent to
carry out specific tasks
(ISO/IEC guide 2).
eg. ISO 9000
eg. ISO 15189; 2012, ISO
17043; 2010.
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24. Accreditation- Why?
Acceptance of test
results within &
beyond borders.
Greater control of
laboratory
process.
Customer
satisfaction. &
Brand value.
Customer can
easily find an
accredited
laboratory

25. Accreditation- How?
• NABL embraces the ISO 15189 Medical
laboratories- requirements for quality and
competence.
• Accreditation given based on laboratories
capability to perform tests and provide
reliable results.
• Assessment based on the ISO 15189; 2012
standard.

26. Requirements for accreditation
• Create a policy document (Quality Manual).
• Appoint a Quality Manager.
• Establish the Quality Management system
• Appoint a technical manager.
• Process breakdown & QI identification.
• Monitor quality indicators and undertake
appropriate CA/PA.
• Documentation.
• Audits
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27. Requirements for accreditation
• Quality manual:
– Satisfy every clause mentioned in the standard
(ISO 15189).
– Greatest document of the QMS (Level 1).
– Describes laboratory policies, organization
structure, job descriptions and personnel
interrelations.
Note:
“Every lab policies traceable to its QM”.
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28. Requirements for accreditation
• Quality Manager:
– Head of the QMS.
– Reports directly to the lab director.
– Keeps the laboratory audit fit.
– Monitors process and continuously improves
them various lab processes.
– Involved in educating and training staff.
• Education- change the way people think.
• Training- change the way personnel work.
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29. Requirements for accreditation
• Quality Management system
– Quality: The degree to which a set of inherent
characteristics fulfils requirements.
– Management: Plan, organize, staff, lead and
control.
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30. Requirements for accreditation
• Technical Manager:
– Usually a senior technical person.
– Appointed by HOD.
– Technical workload management and work
distribution among existing staff.
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31. Requirements for accreditation
• Quality indicators:
– “It measures how well an organization meets the
needs and requirements of users and the quality
of all operational processes”.
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32. Requirements for accreditation
• Establishing QI & continual improvement:
– Lab process broken down to its components and
micro components.
– Identify the common failures or errors that occur
frequently.
– Log the most common errors and the reason
behind the errors.
– Appoint a person to ensure the log is maintained
and updated regularly.
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33. Requirements for accreditation
• Establishing QI & continual improvement:
– Tabulate and identify the major causes for the
errors.
– Present the data with recommended corrective
measures.
– Implement the CA and measure the rate of
success of the corrective action.
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34. Requirements for accreditation
• Properties of QI’s:
– Measurable in terms of numbers.
– Benchmarks should be predefined.
– Results should be subjected to statistical analysis.
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35. Requirements for accreditation
Pre analytical
• Sample collection
• Routing to appropriate location
• Registration into LIS
Analytical
• QC
• Sample processing
• Result genera ration
Post
analytical
• Result validation
• Result transfer.
Lab work breakdown structure and QI identification
Sample rejection.
Sample missing
Double poke
QC failure.
Unscheduled Downtime.
Human error.
Software crash
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36. Documentation
Indicators for good documentation:
• Approved, reviewed and updated regularly.
• Concise, legible, accurate and traceable.
• Amendments & revision are identifiable.
• Current version is available at points of use.
• Follows change control procedure.
• Obsolete documents separated, identified and
retained for defined amount of time.
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37. Documents of the QMS
Quality
Manual
QSP/ SOP
Forms, checklist,
Records.
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38. Document classification in QMS
Internal documents External documents Records
Documents
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39. Document classification in QMS
• Internal documents:
– Documents/ reference material created by the
laboratory for use within the laboratory.
– It is subject to the change control procedures
created by the laboratory.
– It is approved by appropriate personal before
release for use by the laboratory personnel.
– E.g. SOP, QM, QSP.
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40. Document classification in QMS
• External documents:
– Maintained by the laboratory for reference
purposes.
– Created by a third party and is formally published
for use.
– Not subject to the change control procedure of
the laboratory.
– E.g. ISO 15189; 2012 standard, published book.
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41. Document classification in QMS
Records
• Proof/ evidence of activity.
• They have a defined retention period.
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42. Other activities
• Quality Control
– Goal to identify errors before they impact the real
test.
– Also called as repeatability testing or precision.
• Proficiency testing
– Ensure the laboratory tests are accurate.
• Calibration
– All equipment's and instruments are produce
accurate results.
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43. Conclusion
• All Quality management efforts should be
primarily directed toward provision of the best
possible service at the lowest possible price.
• “Quality is Marketing redefined”.