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Cancer Council NSW
Biobank - ISO:9001:2008
Accreditation
Verity Hodgkinson and Freddy Sitas. Cancer Research Division, Cancer Council NSW

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.
For further information please contact Verity Hodgkinson,
Program Manager, Biobanking, at verityh@nswcc.org.au

Table 1: Inventory of aliquots currently held by Cancer Council
NSW Biobank for public health research
Aliquot type (500ul)
Study Name
CLEAR Study*
Skin Health Study
Cervical Health Study
45 and Up Study*
CCNSW Biobank
Stability Study
Johannesburg Cancer
Case Control Study

Serum

Plasma

Buffy Coat

EDTA Red
Cells

45049

101402

18679

X

X

18779

10667

5335

15420

X

X

X

X

26776

10667

3425

6634

15405

2705

954

10424

X

X

X

X: sample type not collected; * open access resource

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Cancer Council NSW Biobank - ISO:9001:2008 Accreditation

  • 1. Cancer Council NSW Biobank - ISO:9001:2008 Accreditation Verity Hodgkinson and Freddy Sitas. Cancer Research Division, Cancer Council NSW 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. For further information please contact Verity Hodgkinson, Program Manager, Biobanking, at verityh@nswcc.org.au Table 1: Inventory of aliquots currently held by Cancer Council NSW Biobank for public health research Aliquot type (500ul) Study Name CLEAR Study* Skin Health Study Cervical Health Study 45 and Up Study* CCNSW Biobank Stability Study Johannesburg Cancer Case Control Study Serum Plasma Buffy Coat EDTA Red Cells 45049 101402 18679 X X 18779 10667 5335 15420 X X X X 26776 10667 3425 6634 15405 2705 954 10424 X X X X: sample type not collected; * open access resource