Laboratory Quality

Management System
 Intended Learning Outcomes
At the end of this lecture, student should be
able to,
• Define the terms quality and quality
management system.
• Identify the importance the quality system
essentials.
• Describe the procedure of implementing
quality management system in a laboratory.

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 Quality ?
Degree to which a set of
inherent characteristics fulfils
requirements
(ISO 9000:2005, definition 3.1.1)

 1) Acceptable
 2) Accessible
 3) Affordable
 4) Appropriate

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 What is Quality?

• It is the accuracy, reliability and timeliness

of reported test results.
The laboratory results must be as accurate as
possible
All aspects of the laboratory operations must be
reliable
Reporting must be timely in order to be useful
in a clinical or public health setting.

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 Quality Management System Definition

Management system to direct and control an

organization with regard to quality
(Adapted from ISO 9000:2005, definition 3.2.3)

All aspects of the laboratory

operation need to be addressed to
assure quality; this constitutes
a quality management system.

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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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• It relates to
– General management activities
– The provision and management of resources
– The pre-examination, examination and post-
examination processes and evaluation
– Continual improvement

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 A good QMS will
• Set direction and meet customers’ expectations
• Improve process control
• Reduce wastage
• Lower costs
• Increase market share
• Facilitate training
• Involve staff
• Raise morale

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Twelve Quality System Essentials

Organization Personnel Equipment

set of
coordinated Purchasing Process Information

activities that
& Control Management
Inventory

function as
building blocks Documents Occurrence
Assessment
for &
Records
Management

quality
management Process Customer Facilities
Improvement Service &
Safety

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Organization Personnel Equipment

Purchasing Process Information

& Control Management
Inventory

Path of Workflow
Documents Occurrence
Assessment
& Management
Records

Process Customer Facilities

Improvement Service &
Safety

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 Organization

Responsibilities,
Authorities

Quality
Planning Policy & Communic
quality ation
objectives

Provision
of
resources
Quality policy: Overall intentions and direction of a
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laboratory related to quality
Example:

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• To have a functioning quality management system,
the structure and management of the laboratory
must be organized.
• So that quality policies can be established and
implemented.
• There must be a strong supporting organizational
structure, management commitment and mechanism
for implementation and monitoring of QMS.

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 Personnel
• The most important
laboratory resource is
competent, motivated staff.
• The quality management system
addresses many elements of personnel
management and the importance of
encouragement and motivation.

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 Elements of personnel management

 Job qualifications
 Job descriptions
 Orientation
 Training
 Competency assessment
 Professional development
 Continuing education
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 Equipment
• Many kinds of equipment are used in the
laboratory, and each piece of equipment must
be functioning properly
• All part of the equipment management
programme in a quality management system.

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 Equipment management includes,
 Acquisition
 Installation
 Validation
 Maintenance
 Calibration
 Troubleshooting
 Service and repair
 Records 17
 Purchasing and Inventory
• The management of reagents and supplies in the
laboratory is often a challenging task.
• This can save cost in addition to ensuring supplies
and reagents are available when needed.
• It ensures that all reagents and supplies are of good
quality, and that they are used and stored in a
manner that preserves integrity and reliability.

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Purchasing and Inventory includes,

• Vendor Qualifications
• Critical Services
• Contract Review
• Inventory Management

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 Process Control
• This is comprised of several factors that are
important in ensuring the quality of the
laboratory testing processes.
• These factors include quality control for testing,
appropriate management of the sample
including collection and handling, and method
verification and validation.

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 Information Management
• This is primarily the test reporting.
• Information (data) should manage to ensure
accuracy, confidentiality and accessibility to the
laboratory staff and to the health care providers.
• Can be managed and conveyed with either paper
systems or with computers.

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 Documents Records
creation collection
revisions and review review
control and distribution storage
retention

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 Occurrence Management
• An “occurrence” is an error or an
event that should not have
happened.
• A system is needed to detect
these problems to handle them
properly and to learn from
mistakes and take action so that
they do not happen again.

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 Laboratory Assessment

• This is a tool for examining laboratory

performance and comparing it to standards,
benchmarks or the performance of other
laboratories.
• Assessment may be internal or external.
• Laboratory quality standards are an important
part of the assessment process.

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 Process Improvement

• The primary goal in a quality

management system is continuous
improvement of the laboratory
processes.
• This must be done in a systematic
manner.
• There are a number of tools that are
useful for process improvement. Eg-:
DRIVE, DMAIC..

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 Customer Service
 customer group identification
 customer needs
 customer feedback

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 Facilities and Safety
• Many factors must be a part of the quality
management of facilities and safety. These
include:
– Security—which is the process of preventing
unwanted risks and hazards from entering the
laboratory space.
– Containment—which seeks to minimize risks and
prevent hazards from leaving the laboratory space
and causing harm to the community.

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• Safety—which includes policies and procedures to prevent
harm to workers, visitors and the community.

• Ergonomics—which addresses facility and equipment

adaptation to allow safe and healthy working conditions at
the laboratory site.

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 Implementation of a QMS
• Management responsibilities in implementing
a QMS
– Set objectives and goals of the QMS
– Appoint a Quality Manager or Quality Team to
develop and maintain the QMS
– Allocate resources required for the development,
implementation and on-going management of the
system

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– Inform all staff and seek participation from all levels
– Assess an appropriate budget based on equipment,
training, time and personnel required
– Assess method for documenting the QMS
– Set timeliness for the various tasks
– Schedule individual departments and positions for
development of policies to reflect laboratory objectives
– Develop procedures and work instructions (SOPs) with
each department

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– Report management any risks and improvement
opportunities that have been found
– Document any quality corrective action requests that
may be identified (identified risk areas that require
management attention and improvements)
– Approve and issue the QMS
– Operate the QMS for a minimum period of 3 months

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– Carry out initial audits to ensure documentation
matched processes
– Ensure that “ you do what you say you do”. If any
deficiencies are found change processes or QMS to
reflect what is actually done
– Assess the effectiveness of the QMS and implement
any changes that might be required
– Undertake management review of the QMS

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 Implementing
Quality Management
does not But it detects
guarantee errors that may
an occur and
ERROR-FREE prevents them
Laboratory from recurring

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Organizatio Personnel Equipment
n

Laboratories not
Purchasing
&
Process
Control
Information
Management implementing a
Inventory

quality management
Documents Occurrence
Assessmen
system guarantees
& Manageme
t
Records nt
UNDETECTED
ERRORS
Process Customer Facilities
Improvement Service &
Safety

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 Standards Organizations

ISO CLSI
International Organization Clinical and Laboratory
for Standardization Standards Institute
(formerly known as NCCLS)

Guidance for quality in Standards, guidelines, and

manufacturing and service best practices for quality in
industries medical laboratory testing

Broad applicability; used Detailed; applies

by many kinds of specifically to medical
organizations laboratories
Uses consensus process in Uses consensus process in
developing standards developing standards

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 CLSI Quality Documents
HS1-A2 A Quality Management System Model
for Health Care
 describes quality system model, 12 essentials
 aligns to ISO 15189 and parallels ISO 9000
 applies to all health care systems

GP26-A3 Application of Quality Management

System Model for Laboratory Services
 describes laboratory application of quality system model
 relates the path of workflow to the quality system essentials
 assists laboratory in improving processes
 relates to HS1-A2 and ISO 15189

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Summary

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THANK YOU

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