ISO 15189 Quality System for
Medical Testing Laboratories
Quality Manual | Accreditation Kit
| ISO 15189 Standard |
Training | ISO Consultant |
15189 Quality Manual
If you wish to document an ISO 15189 quality
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15189 Quality Manual also meets ISO 9001:2008 requirements. It includes 25
associated procedures and 37 forms, which you customize
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documents and measurement uncertainty
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methods presented in the International Organization for Standardization
(ISO) Guide to the Expression of Uncertainty in Measurement
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ISO 15189 Standard from BSI
The ISO 15189:2012 Accreditation Kit for
only $799.00 includes the following
A pre-written quality
manual, including 25
and a work instruction template
for documenting examination/test instructions
Measurement Uncertainty training course
material and free software
implementation plan which can be modified to your needs
ISO Internal Auditor Training (unlimited number of students)
Internal Auditor Training for Small Business Kit (includes a PowerPoint presentation
and exercises and forms in MS Word format)
Safety Training Videos from Compliance and Safety
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Innovations, Inc. is an authorized affiliate of Qualisyst Ltd.
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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.
What is ISO
Medical laboratories — Requirements for quality and competence
was published by ISO in January 2003 and revised in 2007 and
It was developed by the International Organization for
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
medical laboratory to patient care. The objective of ISO
15189 is to establish
a framework for laboratory management so that the laboratory’s
on the users/customers of the laboratory services.
ISO 15189 couples a total quality
approach with documentation methodology to establish a management
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
acceptable turnaround times, how testing is to be provided in a medical
emergency, and the role of the laboratory in the education and training
are the benefits of compliance?
Marketing advantage -
Improved efficiency and
Consistent quality and
timely delivery of services
Improved performance from
personnel clearly defined
Documented system provides
Lower error rates and
Improved control during
periods of change or growth
Improved records in case of
One quality system to meet multiple customer
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