On February 2, 2016, ISO 18385:2016 was published as the first international standard specific to the forensic manufacturing community. Since the standard was published, companies have begun to self-declare that they comply with the ISO standard. Some companies have gone a step further and reached out to Certification Bodies to provide an unbiased and independent assessment their compliance to ISO18385 through a third party audit.
Written by: Charlie Stollberg, Promega
When consumers see an ‘ISO 18385 Forensic Grade’ labeled product, it should inspire confidence that the product was produced in accordance with a minimum set of criteria common to all manufacturers.
So what are you actually getting in a Forensic Grade labeled product?
- Products manufactured under a Quality Management System with procedures and policies for batch tracing, supplier controls, nonconformances, and complaint handling to name a few.
- The ability to contact your supplier in the event of suspected contamination and confidence that the supplier maintains a database of all current employees involved in the manufacture of your product. The supplier should be willing to search their database if minimum supplier specified search criteria are met.
- Confidence that manufacturers have performed rigorous risk assessments of all aspects of the production process and taken necessary actions to minimize the introduction of human DNA into the manufacturing process through appropriate controls.
- Post-production treatment of the consumables used to collect, handle, or store biological materials potentially containing human DNA. These post-production treatment methods must be validated and show that effective DNA reduction was achieved, that product performance is not impacted, and that the treated products are safe for human contact
- Batch-released products with minimum requirements for acceptance as designated by the standard, not individual manufacturer guidelines.
- Products labeled “Forensic Grade” to clearly distinguish them.
As you can see, making a claim of ISO 18385 compliance is no small feat. The ‘Forensic Grade’ label on a product demonstrates that manufacturer has gone to great lengths and made a significant investment to meet the requirements of ISO 18385 in order to ensure the highest product quality for the forensic community.
You may also like:
ISO 18385: The Creation of a ‘Forensic Grade’ Standard
Meeting the New Forensic ISO Standard: ISO 18385
Your ISO 18385 Questions Answered
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