ISO 15189ISO 15189 Medical Laboratories, ISO 15189 Consultancy, ISO 15189 Accreditation, ISO 15189 Certification, ISO 15189 Training
ISO 15189:2007 specifies requirements for quality and competence particular to medical laboratories.
ISO 15189:2007 is for use by medical laboratories in developing their quality management systems and assessing their own competence, and for use by accreditation bodies in confirming or recognising the competence of medical laboratories.
Quality improvement has become a key national and international business strategy. Most Clinical labs are using quality systems as a method of assuring the consistency and conformity of products or services to a defined set of standards or customer expectations.
ISO 15189:2007:
The publication of EN ISO 15189 is an important step towards universal by medical
laboratory professionals of the need for accreditation as a means of demonstrating
to the public, to governments, regulatory bodies and other interested parties that a
laboratory possesses the competence necessary to ensure the high standards of
service which patients and clinicians should be able to take for granted.
ISO 15189:2003 is an international standard developed particularly for the medical
laboratories. Though it is based upon ISO/IEC 17025:1999 and ISO 9000:2000, it is
a standalone standard for medical laboratories with a title particularly referred to
"quality and competence”. Under the International Laboratory Accreditation
Cooperation (ILAC) Multilateral Mutual Recognition Arrangement (MLA),
accreditation of medical laboratories against ISO 15189 and ISO/IEC 17025 are
both acceptable.
The basic idea of the European Union is freedom of movement of people, products and services. This is realized through harmonization of practices, for example in the field of laboratory medicine, a patient wants to be sure that the result of a test can be trusted and is interpreted in the right way during his stay abroad.
The primary aims of both Evidence-based Health Care (EBHC) and quality management of health care services are to improve clinical effectiveness and patients' outcomes. Evidence-based laboratory medicine (EBLM) is an essential tool in the assessment of effectiveness, as high quality systematic clinical research is necessary for investigating the impact of any intervention on clinical outcome.
Implementing ISO 15189 as part of laboratory quality initiatives provides both laboratory and business benefits such as:
- Improved national and global reputation and image of the laboratory.
- Continually improving data quality and laboratory effectiveness.
- Having a basis for most other quality systems related to laboratories, such as Good Laboratory Practices.
- Mutual Recognition Agreement (MRA) amongst various countries test report is acceptable without repetition of analysis.
- Customer satisfaction is achieved through introduction of Quality Management System which is a part of ISO 15189.
- All test equipment will be calibrated and traceable to National Standards so that accuracy of results will be ascertained & maintained.
- Laboratory will be participating in Inter laboratory Comparison program so that quality level of the lab with respect to other accredited lab can be determined.
- Quality control checks will be carried out periodically by which system is always maintained.
We can help your laboratory or hospital to achieve ISO 15189 Accreditation.
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