What is ISO 18385?

ISO 18385 was developed in response to the increasing sensitivity of forensic DNA profiling and the unintentional contamination of consumables used during the Forensic DNA process by the manufacturers.

The potential for DNA contamination can never be totally eliminated but this standard specifies requirements for the production of consumables and reagents used in the collection, storage and analyses of biological material for forensic purposes.

What are the benefits of ISO 18385?

• Provides the structure around which an organization can take a comprehensive risk-based view on implementing controls
• Human DNA contamination free process implementation.

Who is ISO 18385 for?

ISO 18385 can be applied in any organization which manufactures consumables and reagents including those used for evidence collection (sampling kits), such as swabs, containers, and packaging, and also products used in the analysis of DNA samples, such as tubes and other plasticware, disposable laboratory coats, gloves, and other consumables. ISO 18385:2016 applies to the production of consumables and reagents which do not require cleaning for continued use.

Why certify to ISO 18385?

• Demonstrate to your customers your commitment to DNA contamination minimization
• Enhance your reputation and differentiate from the competition
• Identify opportunities for improvement to drive process improvements
• Embed contamination minimization systems in the culture of the organization

Why certify to ISO 18385?

• Demonstrate to your customers your commitment to DNA contamination minimization
• Enhance your reputation and differentiate from the competition
• Identify opportunities for improvement to drive process improvements
• Embed contamination minimization systems in the culture of the organization

How do we demonstrate compliance to ISO 18385?

Our approach to demonstrate compliance follows a clearly defined process.

• Definition of compliance assessment scope
• Audit is performed in 2 stages:
  • Stage 1 – readiness review performed to verify that the organization is ready to progress to the next stage of the assessment.
  • Stage 2 – evaluation of implementation, including the effectiveness, of the management system of the organization
• A certificate, valid for 3 years, is issued upon satisfactory results of the stage 2 audit.
• Annual surveillance audits verify that the management system continues to fulfil the requirements of the standard and monitor the continual improvement
• Re-assessment after 3 years to confirm the continued conformance and effectiveness of the management system as a whole