ISO 15189 Certification in Nepal for Medical laboratory

ISO 15189:2022 – Medical Laboratories Requirements for Quality and Competence

15189:2022 – Medical Laboratories Requirements for Quality and Competence is a standard that was established to ensure the quality and reliability of medical laboratory services. 

ISO 15189:2022 Accreditation

It defines the requirements for medical laboratories to deliver high-quality results and ensure that the medical laboratory services are competent, safe, and reliable.

The Importance of ISO 15189

ISO 15189 is an important standard as it sets the minimum requirements for quality management in medical laboratories. It also provides a framework for the development and implementation of quality management systems in medical laboratories. The standard covers a wide range of laboratory services and functions, including pre-analytical, analytical, and post-analytical processes.

ISO 15189 Benefits

The ISO 15189 standard defines the requirements for medical laboratories to ensure the quality and competence of their analytical processes.

The process of obtaining ISO 15189 certification involves the following steps:

  • Preparation: The organization must identify the scope of its laboratory activities and implement a quality management system to meet the requirements of ISO 15189.
  • Assessment: An assessment by a third-party auditor is conducted to evaluate the organization's quality management system and ensure that it meets the requirements of the standard.

Certification: If the assessment is successful, the organization is awarded ISO 15189 certification.

Surveillance: Regular surveillance audits are conducted to ensure that the organization continues to meet the requirements of the standard.

Re-certification: The organization must undergo re-certification every three years to maintain its ISO 15189 certification.

Process of 15189 Certification

What is the difference between ISO 15189 and 17025?

  • ISO 15189 and ISO/IEC 17025 are two international standards for laboratory quality and competence.
  • ISO 15189 is specific to medical laboratories and focuses on the quality and competence of laboratory services in relation to patient diagnosis and treatment.
  • ISO/IEC 17025 is a more general standard that applies to all types of laboratories, including medical, and sets requirements for the competence, impartiality, and consistent operation of laboratories.

In summary, ISO 15189 is focused on medical laboratories and their impact on patient care, while ISO/IEC 17025 is broader and applies to all types of laboratories.

Controls and Requirements of ISO 15189 Certification

ISO 15189 is a standard that sets the requirements for quality and competence of medical laboratory services. It includes several clauses, which are sections that provide specific information or requirements on a particular topic. The main clauses of ISO 15189 are:

  • Scope: Outlines the purpose and applicability of the standard.
  • Normative references: Lists the other documents and standards that are necessary to understand and comply with the requirements of ISO 15189.
  • Terms and definitions: Defines key terms used in the standard.
  • General requirements: Establishes the general principles and requirements for the management of a medical laboratory, including quality management, personnel, and equipment.
  • Quality management system: Describes the requirements for a quality management system in a medical laboratory, including documentation, control of records, internal audits, and continuous improvement.
  • Pre-examination processes: Outlines the requirements for the preparation and planning of a medical examination, including sample collection, sample transportation, and sample reception.
  • Examination processes: Describes the requirements for the performance and reporting of a medical examination, including measurement and analysis, quality control, and proficiency testing.
  • Post-examination processes: Specifies the requirements for the management of results and information after a medical examination, including report generation, result communication, and result archiving.
  • Management of traceability of results: Outlines the requirements for tracking and tracing results, including identification and labeling of samples, and documentation of results.
  • Complaints and corrective action: Describes the procedures for handling and resolving complaints and implementing corrective actions.
  • Reference values: Provides guidelines for the determination and use of reference values in medical examination results.

Is ISO 15189 Mandatory in Nepal?

Yes, it is mandatory for A-grade medical laboratories in Nepal to undergo ISO 15189 implementation according to the recent guidelines for operating A-grade medical laboratories in Nepal.

What is ISO 15189:2022 Accreditation?

ISO 15189:2022 Accreditation is a standard that ensures the quality and competence of medical laboratory services. It sets the minimum requirements for quality management systems in medical laboratories, covering various processes such as pre-analytical, analytical, and post-analytical processes.

Why is ISO 15189:2022 Accreditation important?

ISO 15189:2022 Accreditation is important as it helps improve the quality of laboratory services, enhances patient safety, and increases confidence in laboratory results. It provides a framework for effective management of laboratory processes, ensuring accurate and reliable testing for medical practitioners and patients.

Who needs ISO 15189:2022 Accreditation?

ISO 15189:2022 Accreditation is intended for medical laboratories and organizations that provide medical laboratory services. It is applicable to both public and private healthcare sectors and ensures the delivery of high-quality and reliable laboratory services.

How can ISO 15189:2022 Accreditation be obtained?

ISO 15189:2022 Accreditation can be obtained by implementing a quality management system based on ISO 9001:2015, meeting the key requirements of ISO 15189, and undergoing a certification process conducted by recognized accreditation bodies. These bodies assess the laboratory's compliance with the standard and issue the accreditation certificate.


ISO 15189 is an important standard that helps medical laboratories deliver high-quality, reliable, and competent services. By meeting the requirements of the standard, medical laboratories can ensure that their services are safe, effective, and of high quality, which helps to build trust in laboratory results and improve patient safety.

Frequently Asked Questions:

1. What is laboratory accreditation? Laboratory accreditation is a formal process in which an independent third-party organization evaluates and certifies a laboratory's competence, technical capabilities, and compliance with international standards. It ensures that the laboratory meets the necessary requirements to produce accurate and reliable results, enhancing its credibility and trustworthiness.

2. How do you respond to an accident in the laboratory? In case of an accident in the laboratory, our team follows strict protocols for immediate response and safety. This includes notifying the supervisor, ensuring affected individuals receive medical attention if necessary, securing the area, and conducting an investigation to identify the cause and prevent future incidents.

3. What is a reference laboratory? A reference laboratory is a specialized facility recognized for its exceptional expertise and proficiency in performing specific diagnostic tests or analyses. These laboratories are sought after for their accuracy and precision, often serving as a standard for comparison and calibration for other laboratories.

4. Why is the laboratory important? Laboratories play a crucial role in various fields, including healthcare, research, industry, and environmental monitoring. They facilitate accurate and reliable testing, research, and analysis, enabling informed decision-making, diagnosis, and quality control.

5. Does Nepal have well-equipped laboratories for trade? Yes, Nepal has several well-equipped and accredited laboratories catering to trade, including testing and certification for products, food safety, textiles, and more. ISO Certification in Nepal Pvt. Ltd. ensures that laboratories meet international standards for trade-related services.

6. What are possible accidents in laboratories? Possible accidents in laboratories include chemical spills, fires, electrical mishaps, equipment malfunctions, and injuries related to handling sharp objects or hazardous materials. Proper safety measures and protocols are essential to minimize the risks.

7. What is efficiency in laboratory practice in Nepal? Efficiency in laboratory practice in Nepal refers to the ability to deliver accurate and timely results while optimizing resources, reducing wastage, and maintaining compliance with quality standards. ISO Certification in Nepal Pvt. Ltd. promotes efficient laboratory management practices.

8. Why is calibration important in the scientific laboratory? Calibration is vital in the scientific laboratory to ensure the accuracy and reliability of measuring instruments and equipment. Regular calibration guarantees that test results are precise and traceable to recognized standards, enhancing the quality of the laboratory's services.

9. Can lab tests be inaccurate? While laboratories strive for accuracy, various factors can lead to inaccuracies in lab tests, such as human error, equipment malfunction, or improper sample handling. Implementing quality control measures and adhering to accreditation standards minimize such risks.

10. How are reference labs established? Reference laboratories earn their status through years of consistent excellence, participation in proficiency testing, publication of research, and recognition from peers and regulatory bodies. They become centers of expertise in their respective fields.

11. How to destroy a positive sample in pathology labs? Positive samples in pathology labs must be disposed of according to specific guidelines and regulations to prevent any potential risks. The destruction process typically involves using approved methods such as incineration or chemical treatment.

12. How to increase lab business in Kathmandu? To increase lab business in Kathmandu, ISO Certification in Nepal Pvt. Ltd. recommends focusing on providing high-quality services, obtaining relevant accreditations, marketing strategies, expanding service offerings, maintaining customer satisfaction, and building strong partnerships within the healthcare and trade industries.

13.what are the components needed in a pathology management system? A pathology management system typically includes essential components such as a patient database, test scheduling and tracking, electronic health records (EHR), laboratory information system (LIS), billing and payment processing, quality control tools, inventory management, and reporting features.

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