Quality & ISO standard

Quality Commitment Statement

Innovate Biotech Co., Ltd. is committed to providing biobanking services and medical laboratory testing services with the highest standards of quality, accuracy, and impartiality in all operations. The Company ensures that its activities comply with international quality standards, applicable laws, regulations, and ethical principles.

The Company places strong emphasis on developing and maintaining an effective quality management system to support continuous improvement, personnel competency development, and the appropriate management of laboratory processes and biological specimens. This includes consideration of biosafety, data accuracy and integrity, specimen traceability, and information confidentiality.

Furthermore, the Company is committed to continuously monitoring, evaluating, and improving the quality of its operations in order to meet the needs and expectations of clients, researchers, and medical professionals, while supporting the advancement of research and the sustainable improvement of public healthcare.

ISO 15189

Medical Laboratories

ISO 15189 is an international standard specifying the quality and competence requirements for medical laboratories. It ensures that laboratories deliver accurate, reliable, and safe diagnostic services for patient care.

This standard emphasizes:

  • Quality management systems
  • Technical competence
  • Personnel training and development
  • Risk management throughout the testing process

Compliance with ISO 15189 ensures that laboratory results support clinical decision-making with the highest level of accuracy and efficiency.

Certificate

ISO 15190

Medical Laboratory Safety

ISO 15190 defines international requirements for safety in medical laboratories, focusing on the prevention of risks such as:

  • Biological hazards and infections
  • Chemical exposure
  • Equipment-related risks

This standard enhances workplace safety for laboratory personnel and strengthens confidence in the quality and reliability of laboratory results.

Certificate

ISO 20387

Biobanking

ISO 20387 is the international standard for biotechnology and biobank, establishing general requirements to ensure the quality, competence, and reliability of biological samples management.

It covers:

  • Collection and processing of biological samples
  • Storage and preservation
  • Data management and traceability
  • Distribution for research and medical use

This standard ensures that biological materials—such as cells, tissues, stem cells, and DNA—are handled under a robust quality system, fostering international trust and recognition.

Certificate

NEBB

Cleanroom Performance Testing

NEBB (National Environmental Balancing Bureau) certification is an internationally recognized standard that validates expertise in:

  • Testing
  • Balancing
  • Performance verification of building engineering systems

This includes:

  • HVAC systems
  • Cleanroom environments
  • Building performance assessments

NEBB certification ensures optimal system performance, stability, and safety, particularly for controlled environments such as cleanrooms, which are critical for laboratory and biobank operations.

Certificate

EQA

External Quality Assessment

External Quality Assessment (EQA) is an independent evaluation program designed to verify the accuracy and reliability of laboratory testing results.

Laboratories receive standardized samples from external organizations, analyze them as routine specimens, and submit results for comparison against reference values or peer laboratories.

Innovate Biotech Co., Ltd. actively participates in international EQA programs, including:

  1. Leucocyte Immunophenotyping (Immune Monitoring Program) – UK NEQAS
  2. Cell Viability Testing – ISBER, Integrated Biobank of Luxembourg (IBBL)

Participation in EQA programs demonstrates our commitment to maintaining high analytical performance and international benchmarking standards.

Certificate

Ethic Approval

Human Research Protection

Innovate Biotech Co., Ltd. has obtained ethical approval from the
Institute for the Development of Human Research Protections (IHRP), under the Health Systems Research Institute (HSRI), Thailand.

This organization is responsible for promoting and regulating ethical standards in human research, ensuring:

  • Protection of participants’ rights
  • Safety and well-being
  • Compliance with international ethical guidelines

Our company has been officially approved to conduct the research project:

“Comprehensive Human Cell Biobank Study”
Approval Date: March 25, 2025

This approval reflects our strong commitment to ethical integrity, transparency, and responsible scientific research.

Certificate