IMPORTANCE OF NABL STANDARDS AS PER ISO: 15189 2022

What is NABL?

The National Accreditation Board for Testing and Calibration Laboratories (NABL) is an autonomous body in India that operates under the aegis of the Department of Science and Technology, Government of India. NABL primary objective is to provide accreditation to testing and calibration laboratories to ensure their competence, reliability, and quality in conducting tests, measurements, and calibrations across various fields.

NABL accreditation is a formal recognition that a laboratory has demonstrated its technical competence and proficiency to perform specific tests and measurements. It contributes to enhancing the quality of laboratory services, fostering trust in testing results, and facilitating trade and technical cooperation.

Key features of NABL include:

1. Accreditation Standards
2. Scope of Accreditation
3. Competence Assessment
4. Quality Management Systems
5. Confidence in Results
6. Global Recognition
7. Continuous Improvement
8. Technical Collaboration
9. Accreditation Programs

NABL accreditation plays a vital role in supporting industries, regulatory bodies, and consumers by ensuring the accuracy and reliability of testing and measurement results. It contributes to the growth of a quality-focused laboratory ecosystem in India and aligns with global best practices for laboratory accreditation.

What is the Vision and Mission of NABL?

The National Accreditation Board for Testing and Calibration Laboratories (NABL) has a vision and mission that guide its activities and goals. Here is the general vision and mission of NABL:

Vision: "NABL vision is to be the leading authority in the field of laboratory accreditation, promoting excellence in laboratory services."

Mission: "NABL mission is to provide government, industry associations and industry in general with a scheme for third-party assessment of the quality and technical competence of testing and calibration laboratories. The scheme provides laboratories with the opportunity to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world."

In line with its vision and mission, NABL works to ensure the quality and technical competence of testing and calibration laboratories through accreditation processes. By establishing and maintaining standards, conducting assessments, and promoting best practices, NABL aims to enhance the credibility and reliability of laboratory services across various fields. This contributes to building trust in laboratory results and fostering excellence in laboratory practices.

What are the standards of NABL?

The National Accreditation Board for Testing and Calibration Laboratories (NABL) offers accreditation programs for various types of testing and calibration laboratories. Each program has its own set of specific standards and criteria that laboratories must meet to achieve accreditation. These standards ensure that laboratories demonstrate technical competence, accuracy, and reliability in their testing and calibration activities.

Here are some of the major accreditation programs offered by NABL along with the corresponding standards:

1. ISO/IEC 17025: This is the general standard for testing and calibration laboratories. It outlines the requirements for the competence, impartiality, and consistent operation of laboratories. It covers areas such as personnel competence, equipment calibration, testing methods, quality control, and reporting of results.
2. ISO 15189: This standard is specific to medical laboratories. It covers the quality and competence requirements for medical testing laboratories, including aspects related to patient care, technical competence, and quality management.
3. ISO/IEC 17020: This standard is for inspection bodies. It defines the requirements for the competence, independence, and impartiality of inspection bodies that provide inspection services.
4. ISO/IEC 17043: This standard is for proficiency testing providers. It outlines the requirements for the competence and quality of providers of proficiency testing schemes, which are used to assess laboratory performance.
5. ISO/IEC 17034: This standard is for producers of reference materials. It covers the competence and quality requirements for the production of reference materials used in laboratories for calibration and quality control.
6. ISO/IEC 17065: This standard is for product certification bodies. It specifies the requirements for bodies that provide certification of products based on specified criteria.
7. ISO/IEC 17021-1: This standard is for bodies providing audit and certification of management systems. It outlines the requirements for organizations that provide certification services for management systems such as ISO 9001 (quality management) and ISO 14001 (environmental management).
8. ISO 22000: This standard is specific to food testing laboratories. It covers the requirements for food safety management systems in laboratories involved in food testing.

It is important to note that the standards mentioned above are internationally recognized and established by organizations such as the International Organization for Standardization (ISO) and the International Electro technical Commission (IEC). NABL accredits laboratories based on their compliance with these standards, ensuring that they adhere to the highest levels of technical competence, quality management, and accuracy in their testing and calibration activities.

Why NABL standard ISO 15189 is important?

NABL standard ISO 15189 is specifically important for medical testing laboratories because it outlines the requirements for quality and competence in medical laboratory testing. This standard plays a crucial role in ensuring accurate and reliable medical test results, patient safety, and the overall quality of healthcare services. Here are some reasons why NABL standard ISO 15189 is important:

1. It focuses on patient safety by ensuring that medical laboratories have the necessary quality management systems and technical competence to provide accurate and reliable test results. 
2. This ensures that laboratories produce accurate and reliable test results, which are crucial for making informed medical diagnoses and treatment plans.
3. The standard emphasizes the importance of having effective quality management systems in place. 
4. ISO 15189 promotes consistent and standardized processes within medical laboratories. This consistency leads to reliable and reproducible test results over time.
5. The standard ensures that tests are conducted by skilled professionals who understand the intricacies of the tests being performed.
6. ISO 15189 encourages medical laboratories to continuously assess and improve their processes. 
7. Accreditation enhances the credibility of the laboratory and its test results.
8. ISO 15189 contributes to the provision of high-quality healthcare services by ensuring that medical laboratories produce reliable data for medical decision-making.
9. ISO 15189 supports the generation of trustworthy data that contributes to advancements in medical science.
10. ISO 15189 is recognized internationally as a standard for medical laboratory quality.
11. ISO 15189 helps medical laboratories adhere to regulatory requirements for quality and safety. 

In summary, NABL standard ISO 15189 is important because it ensures that medical laboratories meet stringent quality and competence requirements, leading to accurate test results, patient safety, and effective healthcare services. It establishes a framework for laboratories to continuously improve their practices and uphold the highest standards in medical testing.

Who are those organizations that can apply for NABL Certification as per ISO: 15189 2022?

This is first question that comes to anyones mind. Organizations that can apply for NABL ISO 15189 2022 Certification are medical laboratories. This includes:

• Diagnostic laboratories
• Hospital laboratories
• Clinical research laboratories

Validity of NABH certification as per ISO: 15189 2022 

The validity of a NABL ISO 15189 2022 Certification typically lasts for three years. However, it is important to consider a few things such as the laboratory needs to undergo surveillance audits by NABL periodically to maintain its accreditation status. These audits ensure the laboratory continues to meet the requirements of the standard.

Future Aspects of NABL Accreditation as per ISO: 15189 2022

The future of NABL ISO 15189 2022 certification is likely to be shaped by advancements in medical technology and a focus on continuous improvement within laboratories. The standard might place a greater emphasis on emerging areas like next-generation sequencing, artificial intelligence, and point-of-care testing. Additionally, there could be a shift towards a more proactive approach to risk management and data security. International harmonization with other accreditation bodies and the potential for remote audits are also possibilities. 

From where someone get more deeper knowledge about NABL Standards as per ISO: 15189 ?

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What should be the learning Objective of NABL Standard course?

• Understand and implement the requirements of ISO 15189 as applied in Medical testing laboratories and Medical Imaging Facilities.
• Develop a quality system which can improve the laboratory operations to meet the needs of their customers.
• Understand and interpret the requirements of ISO 15189:2022
• Develop and implement a system as per ISO 15189:2022 for Medical Laboratory
• Plan, manage, implement and lead the internal audit of Medical Laboratory as per ISO 15189:2022
• Improve the laboratorys operation and system
• Prepare the Medical Laboratory for the NABL accreditation in a structured way