Validation

With respect to quality assurance and laboratory accreditation requirements, all laboratories have to generate and validate Standard Operating Procedures (SOPs), for all the methods in use. However, although validation is required for accreditation, there is little consensus on definitions or guidelines of what is acceptable or appropriate in the field of medical genetics.
Therefore, the main objective for the diagnostic validation workgroup is to establish a structure to centralize and promote the use of SOPs and guidelines and facilitate the implementation of technologies, methods and kits into diagnostic routine activities. It will be reached by coordinating the currently fragmented activities on validation of laboratory methods, technologies and kits, by editing guidelines and by organizing specific and dedicated working groups.
We also propose to create a network of expertise to harmonize approaches and reduce redundancy in the preparation of the SOPs and their validation. The aim is to draft 'generic' method SOPs for the largest possible number of different methods and technological platforms. The network will also be involved in the training of the 'Users' of the different methods and technologies, and in teaching about validation. This will be done in Best Practice Meetings and by on site training sessions.