Adopts ISO18385:2016, which specifies requirements for the production of products used in the collection, storage and analysis of biological material for forensic DNA purposes, but not those consumables and reagents used in post-amplification analysis.
Table of contents
Header
About this publication
Preface
Introduction
1 Scope
2 Terms and definitions
3 Abbreviated terms
4 Types of products
4.1 General
4.2 Products that come into direct contact with biological stains or material potentially containing human DNA
4.3 Chemicals, reagents, solvents, and some disposables involved in the analysis of human DNA
4.4 Protective barrier products that are used during the collection and analysis of biological material
5 Quality management systems
5.1 General
5.2 Documents and records
5.3 Authorization
5.4 Subcontracting of work and purchase of components
5.5 Control of nonconforming product
5.6 Corrective and preventive action
5.7 Staff contamination detection provision
6 Human DNA contamination risk management
6.1 General
6.2 Risk assessment
6.3 Risk mitigation
6.4 Risk control measures
6.4.1 Equipment
6.4.2 Personnel
6.4.3 Cleaning and maintenance
7 Environmental human DNA monitoring
8 Requirements for products subject to post-production treatment
9 Requirements for products not subject to post-production treatment
9.1 Product testing
9.2 Batch records
10 Product packaging, labelling, and documentation
