What is ISO 18385?

ISO 18385 is an international standard that sets standards for quality control in the handling of forensic samples and the manufacture of products.Its official name is ‘International Standard for the manufacture, testing, storage, packaging and transport of DNA samples for forensic applications to minimise the risk of contamination’.The standard provides specific procedures and guidelines to minimise the risk of contamination of forensic samples and products.

Objectives of ISO 18385.

  1. Minimising pollution risks:.
  • It aims to minimize the risk of samples and products for forensic applications producing erroneous results due to DNA contamination. This includes quality control at all stages from the manufacturing process to end use.
  1. Increased reliability:.
  • Ensuring the reliability and consistency of DNA analysis increases the reliability of evidence in the field of forensic science. It thereby plays an important role in legal proceedings and criminal investigations.
  1. International standards provided by:.
  • By providing internationally harmonized standards, it enables forensic institutions and laboratories to work to the same standards. This improves the comparison and reproducibility of results between different countries and institutions.

Main contents.

The ISO 18385 standard covers the following topics

  1. Management of the manufacturing environment:.
  • Ensure that the product manufacturing environment is properly controlled to minimize the risk of DNA contamination. This includes the use of clean rooms and the wearing of appropriate protective equipment.
  1. Sample handling:.
  • Provide guidelines on sample handling and establish appropriate procedures to reduce the risk of contamination.
  1. Storage and transport:.
  • Establish standards for how samples and products are stored and transported to ensure that they can be moved safely without contamination.
  1. Quality Management.
  • Regular quality control and testing ensures that products and samples meet standards.

Importance of ISO 18385.

ISO 18385 is crucial to ensure the handling of DNA samples and the quality of products in the forensic field. Specifically:

  • Improving the reliability of forensic laboratories and institutions:.
  • Compliance with standards increases the credibility of laboratories and institutions and improves their credibility as evidence in court.
  • International cooperation and standardization:.
  • Uniform standards facilitate cooperation between different countries and agencies and contribute to international case resolution.
  • Technological advances and diffusion:.
  • The development and diffusion of standards-based technologies will increase the technical standards of the forensic field as a whole.

Reference information

Further information on ISO 18385 can be found at the following link

ISO 18385 is a key standard for minimizing the risk of contamination of DNA samples in the forensic field, and compliance with it is fundamental to the credibility of legal proceedings and criminal investigations.

Supervisor of the article


Dr. Hiroshi Oka

Director of CAP Laboratory

Graduated from Keio University, Faculty of Medicine

Doctor of Medicine

Medical Doctor