In an increasingly globalized and technologically advanced world, the role of testing laboratories in ensuring the quality and safety of products, services, and research outcomes cannot be overstated. These laboratories conduct essential tests, analyses, and research, impacting public health, product quality, and environmental protection. Thus, laboratories serve as the backbone of quality control, product development, and compliance with international standards across various industries, including pharmaceuticals, food and beverages, environmental testing, and manufacturing. To operate legally and maintain credibility, private laboratories in Thailand must adhere to specific regulations set forth by the government.
Accreditation of Laboratory
Laboratory accreditation is a formal recognition that a laboratory is competent to perform specific tests, measurements, and calibrations. This recognition is based on international standards, such as ISO/IEC 17025, which specify the general requirements for the competence of testing and calibration laboratories. Accreditation ensures that a laboratory’s processes, equipment, and personnel meet rigorous quality standards, thereby guaranteeing the reliability and accuracy of its results. Benefits of laboratory accreditation are:
Enhanced Credibility and Trust:
Accreditation serves as a mark of quality and competence, which significantly enhances the credibility and trustworthiness of a private laboratory. When a laboratory is accredited, it signals to clients, regulatory bodies, and other stakeholders that the laboratory adheres to international standards and consistently produces reliable and accurate results. This increased credibility is particularly important in sectors where precision and reliability are critical, such as healthcare, environmental testing, and food safety. An accredited laboratory can reassure its clients that its findings are valid and its procedures are robust, fostering greater trust and confidence in its services.
Improved Quality and Consistency:
One of the primary benefits of accreditation is the establishment and maintenance of high-quality standards. Accredited laboratories are required to implement stringent quality management systems that encompass all aspects of their operations, from sample handling to data analysis. This leads to improved consistency in test results and measurements, as well as the overall reliability of the laboratory’s output. Continuous monitoring and regular audits ensure that the laboratory’s processes remain compliant with evolving standards, thereby sustaining high levels of performance and reducing the likelihood of errors or discrepancies.
Competitive Advantage:
In a competitive market, accreditation can serve as a significant differentiator. Private laboratories that hold accreditation can leverage this status to attract more clients, secure contracts, and expand their market share. Many industries and clients prioritize working with accredited laboratories to ensure compliance with regulatory requirements and to mitigate risks associated with inaccurate testing. By obtaining accreditation, a laboratory not only enhances its reputation but also gains a competitive edge over non-accredited counterparts, opening up new business opportunities and potential for growth.
Access to Global Markets:
Accreditation facilitates access to global markets by aligning a laboratory’s practices with international standards. In an interconnected world, many industries operate across borders and require testing services that meet universally accepted benchmarks. Accredited laboratories are often recognized by international bodies and regulatory agencies, making it easier for them to participate in global supply chains and collaborate with international partners. This recognition can lead to increased business opportunities abroad and the ability to serve multinational clients who require consistent and reliable testing services across different regions.
Enhanced Internal Processes:
The process of achieving and maintaining accreditation encourages laboratories to adopt best practices in management, documentation, and operational procedures. This often leads to more efficient and streamlined internal processes, which can improve overall productivity and reduce costs. By adhering to a robust quality management system, laboratories can identify areas for improvement, implement corrective actions, and foster a culture of continuous improvement. This not only enhances the quality of the laboratory’s output but also contributes to a more effective and cohesive organizational structure.
Registry Requirements
In Thailand, private environmental laboratories must register with either the Department of Industrial Works (DIW) or the Department of Science Service (DSS) to ensure they meet the applicable standards for operation.
- Department of Industrial Works (DIW) Registration:
- The DIW oversees laboratories involved in industrial activities, ensuring that they comply with environmental and safety standards.
- Laboratories must demonstrate their technical competence, quality management systems, and adherence to relevant regulations.
- The registration process includes submitting detailed documentation, undergoing inspections, and meeting specific technical criteria.
- Department of Science Service (DSS) Registration:
- The DSS focuses on scientific research and development, overseeing laboratories involved in various scientific disciplines.
- Registration with the DSS requires laboratories to showcase their capabilities in conducting accurate and reliable scientific research.
- The DSS also mandates compliance with national and international standards, regular audits, and continuous improvement in laboratory practices.
Regulatory Framework on Labraory
Thailand has established a comprehensive regulatory framework to govern the accreditation and operation of private laboratories. This framework is designed to ensure that laboratories maintain high standards of quality, safety, and environmental responsibility. There are 3 key regulations: Factory Act B.E. 2535 (1992), which governs the establishment and operation of factories, including laboratories within industrial premises. Industrial Product Standards Act B.E. 2511 (1968), which ensures that laboratories involved in industrial product testing adhere to national standards, and Hazardous Substances Act B.E. 2535 (1992), which regulates laboratories handling hazardous substances to ensure safety and environmental protection. Laboratories in Thailand are encouraged to comply with international standards such as ISO/IEC 17025, which specifies requirements for the competence of testing and calibration laboratories. Compliance with these standards helps Thai laboratories gain international recognition and facilitates participation in global markets. To maintain the integrity of the regulatory framework, the DIW and DSS have established robust mechanisms for compliance and enforcement.
Earlier this year, DIW has published the Department of Industrial Works Announcement on Private Analytical Laboratory B.E. 2566 (2023) in the government gazette. This announcement has replaced Department of Industrial Works Rule on Registration of Private Analytical Laboratory published in B.E. 2560 (2017) due to that many recent regulations published by DIW have updated requirements on private analytical laboratory.
Structure of this regulation is summarized as follows.
Definitions
The first section of the announcement provides definitions terms such as “private analytical laboratory”, “pollutions” and “supervisor”.
Qualification of Laboratory
The second section of the announcement specifies rules on the qualification of private analytical laboratories, for example, analytical laboratories that operate under the Factory Act must be registered with DIW. There are 7 requirements for such registration. To be registered with DIW, a laboratory must:
- Be an entity with the objective to hire or provide services related to inspection, sampling, and analysis of waste or pollutants.
- Have supervisor with qualified degree and experience to supervise the operations of the analysis. Such personal must have undergone training in quality control of analytical testing and general requirements for the competence of testing and calibration laboratories according to TIS 17025 (ISO/IEC 17025) or hold a professional license in controlled science and technology, specializing in environmental impact analysis, science, and pollution control, as a expert in monitoring environmental measurements, or have certification of personnel competence according to ISO/IEC 17024 standards in environmental quality control analysis and must work exclusively at the registered analytical laboratory.
- Have personnel with qualified degree and experience.
- Must have procedures for measurement, sample collection, and analyses, including quality control of the analysis in compliance with relevant laws and regulations.
- Must have appropriate safety management measures in the laboratory, such as personal protective equipment, ventilation systems, fume hoods, emergency showers, eye wash stations, and fire suppression systems.
- Must have chemical management and storage that facilitates the safe handling and analysis of chemicals.
- Must evaluate the competency and performance of personnel to ensure that personnel have the capability to conduct laboratory operations consistently and effectively. Personnel competency is crucial for maintaining the balance and reliability of operations.
Method and Equipment
The third section of this announcement specifies method and equipment of tests and other procedures as specified in existing effluent standards: for example, analysis of effluent water must use equipment and method as specified by Standard Methods for the Examination of Water and Wastewater by American Public Health Association, American Water Works Association and Water Environment Federation, and analysis of air discharged must use equipment and method as specified by United States Environmental Protection Agency.
Laboratory Registration
The fourth section of this announcement specifies methods for registration of analysis laboratory and extension thereof. In summary, registration of an analysis laboratory is performed upon an application to DIW. During the registration process, site visit and inspection will be done. The registration is valid for 4 years. Extension of registration can be done 60 days prior to actual expiration. In case of changes in personnel involved, notification to Department of Industrial Works is required.
Laboratory Responsibilities
The fifth section of this announcement specifies duty and responsibility of registered analysis laboratory. This regulation requires that analysis and reporting must be done by qualified and registered personnel. Analysis laboratories are allowed to distribute their analysis reports only for parameters that are registered with DIW. Quality control must be done, and all related documents must be kept for at least 4 years. Subcontracting is only allowed for cases in which task is outsourced from another registered laboratory.
Administrative Measures
The sixth section of this announcement specifies administrative measures that DIW will do when register laboratory does not comply with this regulation. Such measures include preparing written warning, issuing orders to correct or improve within certain timeframe, and suspending or revoking registration.
While the current regulatory framework for private laboratory accreditation and registration in Thailand is robust, there are areas that can be improved to further enhance the efficiency and effectiveness of these processes.
Consistency Across Agencies:
There is a need for greater consistency in the registration and accreditation processes between the DIW and DSS. Differences in requirements and procedures can lead to confusion and inefficiencies.
Transparency in Processes:
Some laboratories have reported a lack of transparency in the accreditation process, including unclear guidelines and inconsistent application of standards. More transparent processes would help laboratories better understand and meet requirements.
Technological Advancements:
The rapid pace of technological advancements in laboratory practices and equipment necessitates regular updates to regulatory standards. Current regulations may not fully address emerging technologies and new methodologies.