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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.
ISO 15189

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

ISO 15189:2003 ISO 9001:2000
  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
  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
  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
  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
  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