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ISO 15189 Standard from BSI
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The ISO
15189:2012 Accreditation Kit for
only $950.00 includes the following
products:
A
pre-written quality
manual, including 27
associated
procedures,
38 forms/checklists,
and a work instruction template
for documenting examination/test instructions
Measurement
Uncertainty training course
material
VQC
Advisor computer-based
training/advisory program
Suggested
implementation plan which can be modified to your needs
Computer-Based
ISO Internal Auditor Training (unlimited
number of students)
ISO
Internal Auditor Training for Small Business Kit (includes a PowerPoint presentation
and exercises and forms in MS Word format)
Order Accreditation
Kit
VQC Advisor is
a computer-based training/advisory program
that provides you with an overview of key ISO management system
requirements and then advises on the best way to customize your
documentation to satisfy those requirements.
ISO Consultant
What is ISO
15189?
ISO
15189
Medical laboratories — Requirements for quality and competence
was published by ISO in January 2003 and revised in 2007, 2012 and
2022.
It was developed by the International Organization for
Standardization's
Technical Committee 212 (ISO/TC 212). The standard
is based on ISO/IEC 17025 and ISO
9001, but it takes into consideration the
specific requirements of the medical environment and the importance of
the
medical laboratory to patient care. The objective of ISO
15189 is to establish
a framework for laboratory management so that the laboratory’s
focus is
on the users/customers of the laboratory services.
ISO 15189 couples a total quality
management
approach with documentation methodology to establish a management
system that
focuses on the elimination of errors with continual
improvement in all
activities. Some elements of the management system include requirements
for collection of patient samples, the interpretation of test
results,
acceptable turnaround times, how testing is to be provided in a medical
emergency, and the role of the laboratory in the education and training
of its
staff.
What
are the benefits of compliance?
-
Marketing advantage -
increased business
-
Improved efficiency and
profitability
-
Increased customer
satisfaction
-
Consistent quality and
timely delivery of services
-
Improved control
of processes
-
Improved performance from
suppliers
-
Responsibilities of
personnel clearly defined
-
Documented system provides
useful reference
-
Lower error rates and
operating costs
-
Improved control during
periods of change or growth
-
Improved records in case of
litigation
-
One quality
system to meet multiple customer
quality requirements
Order Quality
Manual
Software
Training
