Controls and Requirements of ISO 15189 Certification: A Step-by-Step Guide on How to Get Accredited

ISO 15189 has been adopted internationally with a view to enabling medical laboratories to realize the highest degree of quality and competence. The standard given by ISO 15189, no doubt, left much time and space for improvement immensely in ensuring accuracy, reliability, and safety relating to laboratory testing. However, ISO 15189 required a huge range of directives and requirements. In a few words, this can inherently be said to pertain with good QMS at a lab level.
This guide describes major controls and requirements of [ISO 15189 certification](https://www.isocertificationinnepal.com/2023/07/iso-151892022-for-medical-laboratories.html) and describes how following a set of guidelines could give a boost to your credibility and operational efficiency in medical laboratory operations.
![ISO 15189 (1).png](https://qiita-image-store.s3.ap-northeast-1.amazonaws.com/0/3969954/6b70ec25-e38b-bf08-615b-1ee1e7da98cd.png)

1. Create a Robust QMS
ISO 15189 is based on a well-organized [Quality Management System](https://www.isocertificationinnepal.com/2023/06/iso-90012015-quality-management-system.html). QMS guarantees that all the operations are optimally performed in a laboratory, including considerations about accuracy, safety, and efficiency. The key components include:

a. SOPs: Document all practices concerning every activity of the laboratory that comprises handling the samples to the reporting of the results in writing. 
b. Process Control: There has to be monitoring and review of the processes of the laboratory relating to maintaining consistency.
c. Corrective Actions: Avail mechanisms that concern dealing with the non-conformities, and give chances of improvement to the operations. 

2. Personnel Competency Standards
ISO 15189 requires that, in addition to the laboratory services being competent and working effectively, it is the responsibility of the laboratory to ensure that all personnel concerned are competent and suitably trained for the function undertaken. A few of the key requirements as far as personnel are concerned would include:

a. Qualifications and Training: There must be appropriate education and experience within their discipline. The personnel shall always be within competency maintenance training.

b. Performance Monitoring: The competence of staff has to be regularly verified and on a regular basis if the ISO standard is to be maintained.

3. Equipment Calibration and Maintenance
According to the ISO 15189, all equipment within the laboratory must be maintained and calibrated so that diagnostic results are reliable. This shall include:

a. Routine Calibration: The frequent calibration of equipment against known standards.
b. Maintenance Records: Records are to be kept regarding maintenance so the equipment is working properly.
c. Preventive Maintenance: Scheduled checks with the intent of minimizing chances of failure and maintaining the accuracy of the equipment.

4. Sample Handling and Traceability
Sample handling shall be carried out in a manner to ensure valid test results. ISO 15189 covers the following:

a. Sample collection and Transportation: well-documented process on safe collection, storage, and transportation at all times.
b. Traceability: establishing processes allowing sample traceability through all test processes.
c. Quality Control: Controls to be carried out at regular intervals to prevent deterioration and contamination of samples

5. To introduce Risk Management Processes
The ISO 15189 states that the laboratory shall identify, evaluate, and act upon mitigation against all risks that can affect the laboratories' operations and the patient's safety. This shall include:

a. Risk Analysis: To periodically analyze processes, equipment, and personnel to find their potential risks.
- Identification of safety procedures and proper establishment of such procedures which minimize hazards to workers
b. Contingency Plans: Emergency preparedness regarding contingency plans against malfunctioned machinery and even natural calamities

6. Compliance to the Regulations
ISO 15189 certification signifies that the laboratories have full compliance with nationally and internationally accepted regulations, the requirements to comply with the regulations include :

a. Legal Compliance: The various processes followed in the laboratory should be according to the pre-set legal standards both locally and internationally.
Accurate documentation and reporting will also prove regulatory compliance.

b. Internal audits and inspections: The requirements of maintenance on a continuous basis may be checked and ensured through periodic internal audits and inspections within an organization.

7. Emphasis on continuous improvement
ISO 15189 is not something that one achieves. It's commitment to excellence. Laboratories must:

a. Set Quality Objectives: Clearly defined and measurable objectives indicating guidelines to be adopted by the operation of the laboratory for improvement in performance.
b. Internal Audit: The QMS shall be subjected regularly to internal audits whether or not it is adequate, effective, maintained, and improved.
c. People - Training and Development: To update human resources competently to cope with advanced knowledge and techniques.

Why ISO 15189 Accreditation Matters to Medical Laboratories
The controls and requirements of ISO 15189 will achieve the following critical milestones for the medical laboratories:

a. Improved Quality and More Accurate Results: Improved quality of diagnosis, accuracy.

b. Guaranteed Standards of Care and Safety to the Patient: Assurance in standards of care and safety to the patient at the level that is required.

c. International Recognition: Recognition and credibility within the global healthcare market.

d. Operational Efficiency: Enhance operational efficiency in laboratory functions by minimizing errors and efficiently using available resources.

Conclusion
No medical laboratory intending to be among the best in diagnostic services would wish to miss this ISO 15189 certification. There are clear-cut controls and requirements to follow, and only a very robust QMS shall pave the way for the advancement of operations, hence offering patient safety with worldwide credibility.

Get started with the ISO 15189 accreditation procedure now, and let your laboratory be an example for this sector in terms of quality and competency.