ORGANIZATION Flashcards
used to indicate the management and the supporting organizational structure of the laboratory
ORGANIZATION
laboratory leaders must be fully committed to implementation of the system
LEADERSHIP
should be clearly defined, and this should be reflected by a functional organization chart with clear assignment of responsibility.
ORGANIZATIONAL STRUCTURE
skills for planning are needed and planning should address a time frame
PLANNING PROCESS
requires that a number of issues must be addressed by a management staff.
IMPLEMENTATION
essential to the primary goal of a quality system, which is continuous improvement.
MONITORING
means by which the policies are established and communicated to the staff and the users of the laboratory.
QUALITY MANUAL
responsible for developing policies, assigning authority and responsibility to the appropriate persons,
LABORATORY DIRECTOR
assist in developing policies, planning and implementing the quality management system.
QUALITY MANAGERS
responsible for understanding the organizational structure of the laboratory,
LABORATORY STAFF
the route of a sample through the laboratory, from collection to reporting of a result.
PATH OF WORKFLOW
the person most directly responsible for ensuring that the quality policies and procedures are carried out.
QUALITY MANAGER
Quality manager
ISO 15189
what should be done
OBJECTIVES AND TASK
who will get the job done, who will be responsible
RESPONSIBILITIES
when will each task be worked on, when will be completed
TIMELINE
additional staff, training needs, facilities, equipment, reagents and supplies , quality control materials
BUDGET AND RESOURCE NEEDS
essential for monitoring progress in implementation
BENCHMARKS
a document which fully describes the quality management system of an organization.
QUALITY MANUAL
The manual should contain the following:
• ALL QUALITY POLICIES OF THE LABORATORY
• A REFERENCE TO ALL PROCESSES AND PROCEDURES
• A TABLE OF CONTENT
characteristic of organizational systems
- HOLISTIC AND SYNERGISTIC WITH CLEARLY DEFINED BOUNDARIES
- PURPOSELY ACTIVITY AND A PRIMARY TASK
- HIERARCHY OF SYSTEMS
- OPERATES AS AN OPEN SYSTEM
- SEEK A STATE OF STABILITY AND EQUILIBRIUM
- SELF-REGULATING
needed resources are acquired and replaced.
INPUT
resources received through the input channels must be converted into the products and services offered by the organization.
TRANSFORMATION
products and services produced by the organization are delivered to its customers.
OUTPUT
related activities are grouped together to expedite the production process
DEPARTMENTALIZATION
the decision-making process is brought as close to those who are actually performing the work as possible.
DECENTRALIZATION
each individual must have only one boss.
UNITY OF COMMAND
supervision should be a linear system providing a direct vertical link from the board of directors to the lowest-level worker.
SCALAR PRINCIPLE
the manager and staff are able to do their jobs without having to check with a supervisor about every detail.
EXCEPTION PRINCIPLE
PRINCIPLES OF ORGANIZATIONAL STRUCTURE AND AUTHORITY
DEPARTMENTALIZATION
DECENTRALIZATION
UNITY OF COMMAND
SCALAR PRINCIPLE
SPAN OF CONTROL
EXCEPTION PRINCIPLE
