PD ISO/TR 22758 discusses the implementation guide for ISO 20387 for biobanking. PD ISO/TR 22758 outlines guidance to biobanks on how to implement the quality management, management, and technical requirements of ISO 20387. PD ISO/TR 22758 expands on aspects of ISO 20387. PD ISO/TR 22758 provides examples for illustration purposes. PD ISO/TR 22758 is equally applicable to newly established and existing biobanks.
PD ISO/TR 22758 helps biobanks address the competency of personnel and appropriate quality of biological material and data collections.
Note: PD ISO/TR 22758 does not apply to biological material intended for feed/food production, laboratories undertaking analysis for food/feed production, and/or therapeutic use.
PD ISO/TR 22758 on implementation guide for ISO 20387 for biobanking is useful for:
At the time of acquisition, biobanks can perform acquisition, processing, and storage of BMaD for not yet-identified future use(s). The biobank can acquire the BMaD according to standard operating procedures (SOPs) appropriate for the projected end-use(s). Alternatively, biobanks can acquire BMaD in response to a request from a user. The user can specify criteria for the BMaD and/or SOPs developed or applied for that specific use.
PD ISO/TR 22758 provides the best practice guidance on Background information for the development of ISO 20387, Fitness for the intended purpose (FIP) (ISO 20387:2018, 3.24) in biobanking, Process landscape, and Conformity with ISO 20387 for implementation guide for ISO 20387 for biobanking.
PD ISO/TR 22758 provides General, Structural, Resource, Process, and Quality management system requirements on Guidance on the interpretation of selected ISO 20387:2018 text parts. This helps in achieving personnel and appropriate quality of biological material and data collections.
BSI recommends this version of standard for organisations operating in or with the UK. The ISO edition is available here if required.