What is the difference between accreditated and not accreditated CRM?
Biosisto produces certified microbiological reference materials. The certified materials have a subdivision into four types of material.
The difference between the types of certified material is reflected in the strain’s metrological traceability, the property value’s determination, and whether it is part of the flex-scope of accreditation by the Dutch Accreditation Council.
| Requirement | RM type - | CRM type 1 | CRM type 2 | CRM-type 3 |
|---|---|---|---|---|
| ProductName prefix | RM - | CRM - | CRM - | CRM - |
| Assessment and monitoring of homogeneity and stability | X | X | X | X |
| Metrological traceability of strain (1) | Optional | X | X | X |
| Assignment of the uncertainties of the property values (2) | Optional | X | X | X |
| Property value | RM type - | CRM type 1 | CRM type 2 | CRM type 3 |
|---|---|---|---|---|
| Characterization and assignment of property values | X | X | X | X |
| Property value is determined with the homogeneity assessment | X | X | - | - |
| Property value is determined by an internal test performed with multiple analysts, different batches and media suppliers | - | - | X | - |
| Property value is determined by a network of 5 accredited, external, laboratories | - | - | - | X |
| Metrological traceability of Property value | - | - | - | X |
| Accreditation ISO 17034 | RM type - | CRM type 1 | CRM type 2 | CRM type 3 |
|---|---|---|---|---|
| Accredited by Dutch Accreditation Council (3) | - | - | X | X |
1 The strain is traceable to a recognized WFCC culture bank
2 The uncertainties of the property values are available two years after product introduction
3 RVA P001 Reference Mat – A logo of the RvA is then visible on the Certificate of Analyses
