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Yogesh Pawar
CTO
TechnoSysCon
Shree Nathji Heights,
Plot No.- 72,
Behind Chikhli Telephone Exchange,
C.D.C. Purnanagar, Chinchwad, Pune. PIN - 411019
Telefax - +91 20 2749 0009,
Mobile - 09423005866
info@technosyscon.com,
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ISO 15189:2003 Consultants In Pune India
ISO 15189:2003 -
Medical laboratories: particular requirements
for quality and competence
Published in 2003,
and quickly became a widely accepted standard
to be used for accreditation of clinical laboratory
competence. Its main objective is to allow laboratories
to organize their operational procedures efficiently,
meet the expectations of their clients and improve
their service.
The ISO 15189 standard is an important template
for assessing the competence of medical laboratories
in their technical capacity and the effective
quality management of a professional service and
its staff - with or without the aim of accreditation.
ISO 15189 by itself is not a generic (certification)
standard, but a specific one, which means that
it is a guideline for orientation, with a more
technical approach. It is also very useful for
understanding how the requirements of the generic
certification standard ISO 9001:2000 – Quality
Management - can be applied to clinical laboratory
activities. The ISO 15189 standard can be understood
as a practical complement to the generic requirements
described in the ISO 9001. Even with a technical
approach, ISO 15189, like ISO 9001:2000, presents
requirements more related to quality management
than to operational procedures.
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Keep in mind that the standard does not replace
national regulations related to health services,
but the possible adoption of ISO 15189 by accreditation
agencies in the near future – CAP, COLA
and JCAHO in the United States, and other national
agencies in several other countries all over the
World – will make it the basic standard
guiding and harmonizing the accreditation process
of clinical laboratories.
The ISO 15189 standard is divided in two major
parts:
• Management requirements: generic requirements
related to quality management systems
• Technical requirements: specific requirements
related to activities carried out by clinical
laboratories
| Comparioson |
| ISO
15189:2003 |
ISO 9001:2000 |
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4 Quality management system |
| 4.1.5; 4.2, Quality management
system |
4.1 General requirements |
| 4.3 Document control; 5.1.2;
and 5.4, Pre-examination procedures |
4.2 Documentation requirements |
| 4.2.4 |
4.2.2 Quality manual |
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5 Management responsibility |
| 4.1.2,4.1.5 items a) and
h), 4.2.1 and 4.2.3 |
5.1 Management commitment |
| 4.1.2, 5.2.3 and 5.4.2 |
5.2 Customer focus |
| 4.1.5 and 4.2.3 |
5.3 Quality policy |
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6 Resource management |
| 4.1.5 a) |
6.1 Provision of resources |
| 4.1.5 g) and 5.1, Personnel |
6.2.1 General |
| 5.1.2, 5.1.6, 5.1.10 and
5.1.12 |
6.2.2 Competency, awareness
and training |
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7 Product realization |
| 4.10.1; 5.2, Accommodation
and environmental conditions; 5.3, Laboratory
equipment; and 5.8, Reporting of results |
7.1 Planning of product realization |
| 4.4.Review of contracts |
7.2.1 Determination of requirements
related to the product |
| 5.4.5; 5.6, Assuring the
quality of examination procedures |
7.5.3 Identification and
traceability |
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8 Measurement, analysis
and improvement |
| 4.9, Identification and control
of nonconformities |
8.1 General |
| 4.8, Resolution of complaints |
8.2.1 Customer satisfaction |
| 4.12, Continual improvement |
8.5.1 Continual improvement |
Knowing the technical
requirements of ISO 15189:2003
5. Technical Requirements
5.1 Technical Requirements
5.2 Accommodation and environmental conditions
5.3 Laboratory Equipment
5.4 Pre-examination procedures
5.5 Examination procedures
5.6 Assuring quality of examination procedures
5.7 Post-examination procedures
5.8 Reporting of results
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