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.

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.

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.

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

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.

Sample handling:.

Provide guidelines on sample handling and establish appropriate procedures to reduce the risk of contamination.

Storage and transport:.

Establish standards for how samples and products are stored and transported to ensure that they can be moved safely without contamination.

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 official website

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.

医師監修監修日：2024年8月7日

岡博史（おかひろし）

医師・医学博士／ヒロクリニック統括院長

YouTubeチャンネルなどを通じて、遺伝子やNIPT（新型出生前診断）についてわかりやすく発信しています。

略歴

1996年慶應義塾大学医学部卒業
2004年慶應義塾大学医学博士号取得
2005年慶應義塾大学皮膚科学教室助手
2008年ヒロ皮フ形成クリニック開業
2009年医療法人社団福美会理事長
2015年医療法人社団福美会理事

資格・所属

CAPラボディレクター
日本皮膚科学会皮膚科専門医
日本医師会産業医
東京衛生検査所指導監督医

発信・関連リンク

この記事は、ヒロクリニックNIPPTの編集・監修体制にもとづき、資格を持つ医師が内容を確認しています。

医師監修監修日：2024年8月7日

堤修一（つつみしゅういち）

医師・医学博士／ヒロクリニック博多駅前院院長

略歴

1993年東京大学医学部医学科卒業
2016〜2019年東京大学先端科学技術研究センター准教授

発信・関連リンク

プロフィール詳細

この記事は、ヒロクリニックNIPPTの編集・監修体制にもとづき、資格を持つ医師が内容を確認しています。

参考文献

International Organization for Standardization. ISO 18385:2016: Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes — Requirements. Geneva: ISO; 2016.