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.

RequirementRM type -CRM type 1CRM type 2CRM-type 3
ProductName prefixRM -CRM -CRM -CRM -
Assessment and monitoring of homogeneity and stabilityXXXX
Metrological traceability of strain (1)OptionalXXX
Assignment of the uncertainties of the property values (2)OptionalXXX
Property valueRM type -CRM type 1CRM type 2CRM type 3
Characterization and assignment of property valuesXXXX
Property value is determined with the homogeneity assessmentXX--
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 17034RM type -CRM type 1CRM type 2CRM type 3
Accredited by Dutch Accreditation Council (3)--XX

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


Biosisto - Quality in Control

Microbiological laboratories should be able to receive reliable analysis without much overhead. A microbiological analyst must be able to focus on the primary activities, for example analysis of the sample material. Quality control should support the analyst in a logical and simple manner. By using modern information technology, process control and quality assurance are designed smarter and more effective.

Biosisto b.v.
Martin Luther Kingweg 3
9403 PA Assen, The Netherlands