ISO 15189:2012
ISO 15189
ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization’s Technical Committee 212 (ISO/TC 212).
ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories.
This working group included the provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab’s role in the education and training of health care staff.
While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.
PURPOSE
This text is probably the most challenging on the “ISO series update” since many reviews have been published related to ISO 15189 3rd edition. Therefore, this essay is intended to discuss some specifications briefly and to debate what is happening with ISO 15189 implementation in the world. The standard document is focused on the medical laboratory, and its goals can be interpreted as the satisfaction of interested parties. Stakeholders cannot be understood as customers only, such as patients, but inclusive of any internal or external involvement with the medical laboratory, including, but not only, professionals, suppliers and accreditation agencies. “The customers’ satisfaction” can be understood as the contribution of the reported results to an accurate clinical decision. For this purpose, this international standard is based not only on a management system but also on a set of medical laboratory technical specifications. Despite the lab sustainability should be controlled, it is not mandatory. Such as common in others ISO standards, “shall” stipulates a requirement, “should” specify a recommendation, “may” instructs permission, and “can” suggests a possibility or a capability. Only the “shall” signifies that a particular specification is compulsory.
ISO 15189:2012 STRUCTURE
This standard was first published in 2003, and it was 2nd revised in 2007 and current revision is 2012. In this standard 5 clauses & Three Annexure are as follows:
Clauses
- Introduction & Scope
- References
- Terms & Condition
- Management Requirements
- Technical Requirements Clauses
Annex A-Correlation with ISO 9001:2008
Annex B-Comparison of ISO 15189:2007
ISO 15189 is applicable to following types of laboratories:
- Microbiology and Serology
- Clinical Biochemistry
- Clinical Pathology
- Cytopathology
- Nuclear medicine (in-vitro tests only)
- Haematology and Immunohaematology
- Histopathology
- Genetics
ADVANTAGES:
A. For Medical Laboratories
provides an opportunity for external perspectives on the laboratory’s practice, can prevent the unnecessary duplication of information gathering on performance often required by regulatory bodies, encourages the sharing of best practice,reduces risk, and Provides international recognition.
B. For Healthcare Regulators
provides an independent assurance of quality and safety, provides a mechanism for measuring quality improvement, supports consistency in the quality of care, encourages innovation
C. For Patients
consistency in the quality of care, up-to-date technologies and its procedures and techniques reflect current best practice, Staff providing the service is competent to undertake the tasks they perform.
