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.
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.
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?
Why is ISO 15189:2022 Accreditation important?
Who needs ISO 15189:2022 Accreditation?
How can ISO 15189:2022 Accreditation be obtained?
Conclusion
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.