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ORGANIZATIONAL REQUIREMENTS

FOR A QUALITY MANAGEMENT


SYSTEM

Defenition

The term organization in the context of quality


management model is used to indicate the management
and the supporting organizational sturcture of the
laboratory
Management at all levels must fully support
and activety participate in the quality system
activities

The principal element Support should be visible of staff so that there


for a successfull quality is and understanding of the importance of the
management system is
managerial commitment effort

Without the engagement of management,


including the decision – making level of the
organization, it will not be possible to put in
the place the policies and the resources
needed to support a laboratory quality
management
Key Organizational
Components

Leadership

Organizational structure

Planning process

Implementation

Monitoring
MANAGEMENT ROLE

1. Providing 4. providing
vision encouragement.

A good leader will exercise


responsible authority. Important
roles for a leader include:

3. motivating
2. giving a direction staff
for goal-setting
ORGANIZATIONAL
STRUCTURE

Element of Stucture

The path of work flow is the


route of a sample through the An accurate and complete
laboratory, from colection to organizational chart in
reporting a result necessary

Resource allocation must be


A quality management
sufficient to ensure that
system must have a
personal and infrastructure
qualiality manager
needs are met
ISO 15189 states that a laboratory must have a quality
manager. The quality manager is the person most directly
reponsible for ensuring that the quality policies and
procedures are carried out
monitoring all aspects of the quality
system

ensuring staff are following quality


policies and procedures

regularly reviewing all records; for


example, quality control and external
quality assessment that are part of the Some typical
quality system responsibilities of the
quality manager wiil
include:
organizing internal audits and
coordinating external audits

investigasing any deficiencies


identified in the audits process
monitoring

informing management on all aspects


of the quality system
ORGANIZATIONAL FUNGTIONS:
PLANNING

What the
What quality resouercess
practices are will be
already in use available?
the laboratory?

Approacches
to planning

What is the level


of knowledge of
current staff?
ORGANIZATIONAL FUNCTIONS:
IMPLEMENTATION

Beginning Implementation

Commit from the beginning to complete the project


and achieve the etablished objectives

Prepare to implement in stages

Determine resource resource requirements early in


the process, and secure the nesessary resources
before starting tasks

Engage all staff by communicating effectively


THE LABORATORY QUALITY
MANUAL

The quality manual is a


document which fully
describes the quality
management system of an
organization

ISO 15185 requires that


laboratories have a quality
manual, altough style and
structure are not specified
The manual should contain
the following:

1. All quality policies of the


laboratory

2. A reference to all processes and


procedures

3. A table of contens
THANKS FOR YOUR
ATTENTION!!!