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Background Cancer Council NSW biobank processes, stores and despatches biological samples from cancer patients and controls in large epidemiological studies. Currently, we have biological samples from 28,000 people in storage. A breakdown of aliquots per study, currently held by the biobank, can be seen in Table 1. Samples are linked to comprehensive self-reported questionnaire data covering lifestyle, demographic and health related information. Aims Our aims were to improve quality in the biobank ensuring that international best practice is followed through the development and implementation of a quality management system (QMS) and, achieve ISO 9001:2008 accreditation. The decision to pursue ISO accreditation was influenced by the experience of biobanks overseas and the positive contribution that accreditation made towards achievement of government contracts, improving the quality of biospecimens available for research, best practice in biobanking, enhancing interoperability between biobanks and lack of an internationally recognised biobank specific accreditation option. Methods QMS implementation involves a comprehensive review of documentation and systems and closure of identified gaps. The two step formal accreditation process follows system implementation and is conducted by an accredited external reviewer. The first step includes an audit of documents to ensure compliance with ISO standards. The second step involves an observational audit of operations to ensure that the documented procedures are followed. Accreditation follows if these standards are met. Results The process of accreditation has significant benefits for staff engagement, consumer confidence, standardisation and continuous improvement of processes, ultimately ensuring use of high quality biospecimens and better research outcomes. Conclusions As a result of ISO accreditation, we now offer a blood processing and storage service for researchers external to Cancer Council NSW. Triennial accreditation will ensure that these benefits continue into the future. Cancer Council NSW Biobank - ISO:9001:2008 Accreditation Verity Hodgkinson and Freddy Sitas. Cancer Research Division, Cancer Council NSW For further information please contact Verity Hodgkinson, Program Manager, Biobanking, at [email protected] Study Name Aliquot type (500ul) Serum Plasma Buffy Coat EDTA Red Cells CLEAR Study* 45049 101402 18679 X Skin Health Study X 18779 10667 5335 Cervical Health Study 15420 X X X 45 and Up Study* X 26776 10667 3425 CCNSW Biobank Stability Study 6634 15405 2705 954 Johannesburg Cancer Case Control Study 10424 X X X X: sample type not collected; * open access resource Table 1: Inventory of aliquots currently held by Cancer Council NSW Biobank for public health research

Cancer Council NSW Biobank - ISO:9001:2008 Accreditation

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Cancer Council NSW biobank processes, stores and despatches biological samples from cancer patients and controls in large epidemiological studies. As a result of ISO accreditation, we now offer a blood processing and storage service for researchers external to Cancer Council NSW.

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Page 1: Cancer Council NSW Biobank - ISO:9001:2008 Accreditation

BackgroundCancer Council NSW biobank processes, stores and despatches biological samples from cancer patients and controls in large epidemiological studies. Currently, we have biological samples from 28,000 people in storage. A breakdown of aliquots per study, currently held by the biobank, can be seen in Table 1. Samples are linked to comprehensive self-reported questionnaire data covering lifestyle, demographic and health related information.

AimsOur aims were to improve quality in the biobank ensuring that international best practice is followed through the development and implementation of a quality management system (QMS) and, achieve ISO 9001:2008 accreditation. The decision to pursue ISO accreditation was influenced by the experience of biobanks overseas and the positive contribution that accreditation made towards achievement of government contracts, improving the quality of biospecimens available for research, best practice in biobanking, enhancing interoperability between biobanks and lack of an internationally recognised biobank specific accreditation option.

MethodsQMS implementation involves a comprehensive review of documentation and systems and closure of identified gaps. The two step formal accreditation process follows system implementation and is conducted by an accredited external reviewer. The first step includes an audit of documents to ensure compliance with ISO standards. The second step involves an observational audit of operations to ensure that the documented procedures are followed. Accreditation follows if these standards are met.

ResultsThe process of accreditation has significant benefits for staff engagement, consumer confidence, standardisation and continuous improvement of processes, ultimately ensuring use of high quality biospecimens and better research outcomes.

ConclusionsAs a result of ISO accreditation, we now offer a blood processing and storage service for researchers external to Cancer Council NSW. Triennial accreditation will ensure that these benefits continue into the future.

Cancer Council NSW Biobank - ISO:9001:2008

AccreditationVerity Hodgkinson and Freddy Sitas. Cancer Research Division, Cancer Council NSW

For further information please contact Verity Hodgkinson, Program Manager, Biobanking, at [email protected]

Study NameAliquot type (500ul)

Serum Plasma Buffy CoatEDTA Red

Cells

CLEAR Study* 45049 101402 18679 X

Skin Health Study X 18779 10667 5335

Cervical Health Study 15420 X X X

45 and Up Study* X 26776 10667 3425

CCNSW Biobank Stability Study

6634 15405 2705 954

Johannesburg Cancer Case Control Study

10424 X X X

X: sample type not collected; * open access resource

Table 1: Inventory of aliquots currently held by Cancer Council NSW Biobank for public health research