LIITELUETTELO - BIOPANKKITOIMINTA 1/1

LIST OF APPENDICES – BIOBANKING

1. Proposal for the scope of accreditation being applied for, in Finnish and/or in English
(see Appendix 1)
2. Initial description of competence (see Appendix 2)
3. Proof of the type of organisation (a trade register extract or similar document)
4. Information on personnel responsible for the operations to be accredited
- education, experience and responsibility areas (in brief)
5. List of accreditations granted to the applicant and other applications for accreditation and the need for
the continuation of already granted accreditations
6. Relevant management system documentation describing the operations to be accredited
7. Methods, descriptions of procedures or other technical instructions concerning the operations to be
accredited
8. Internal audit reports and management review for the operations for one year period
9. A survey of the biobank’s participation in proficiency tests/in interlaboratory comparisons
10. A list of the essential equipment used in the applied scope of accreditation
11. A survey of operating biobank activities (obligation of authorities or other, when have the activities
started, wideness of activity)
12. A survey of subcontracting (wideness)

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BIOPANKKITOIMINNAN PÄTEVYYSALUE
SCOPE OF ACCREDITATION

Biologinen materiaali Prosessi/Toiminto/Menettely Säilytysolosuhteet (Sisäinen) Menetelmä

Esim.
Kokoveri Vastaanotto, jako alieriin, -80°C Sisäinen menetelmä
pakastus, säilytys XXX-123
                       
                       
                       
                       
                       
                       
                       
                       
                       
                       
                       
                       

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The questions below have been drawn up on the basis of Standard SFS-EN ISO 20387:2020. The applicant
should answer the questions or indicate for each question where in the Quality Manual or some other docu -
ment the specific item is described

Kyllä Ei Viittaus
Yes No johtamisjärjestelmän
dokumentaatioon
Reference to the
managements system
documentation
Impartiality, confidentiality
(SFS-EN ISO 20387:2020, 4)
Has the biobank identified risks to its impartiality? Has the biobank ☐ ☐
established processes or identifying risks and eliminating or
minimising risks on an on-going-basis?
Has the biobank ensured the confidentiality of operations, including ☐ ☐
external bodies and personnel involved in the operations?
Personnel
(SFS-EN ISO 20387:2020, 6.2)
Are the responsibilities and authorities defined for personnel? ☐ ☐
Are the competence requirements determined for all personnel who ☐ ☐
work affecting the results of biobank activities?
Is the competence of personnel ensured? Is the maintenance of ☐ ☐
competence monitored?
Are there procedures for training, supervision and authorization of ☐ ☐
personnel, as well as monitoring competence of personnel?
Facilities and environmental conditions, equipment and calibration
(SFS-EN ISO 20387:2020, 6.3, 6.5)
Are requirements for the facilities and environmental conditions of the ☐ ☐
biobank defined? Are they documented and monitored?
Has the biobank established a procedure for handling, transport, ☐ ☐
storage, use and planned maintenance of equipment?
Is the measuring equipment calibrated when calibration is necessary? ☐ ☐
Has the biobank established a calibration program, which maintains
confidence in the status of calibration?
Does the biobank perform internal calibrations? ☐ ☐
Has the biobank ensured metrological traceability and ensured the ☐ ☐
measurement results are traceable to the International System of
Units (SI)?
Externally provided processes, products and services
(SFS-EN ISO 20387:2020, 6.4)
Has the biobank ensured suitability and conforming requirements of ☐ ☐
externally provided products and services that affect laboratory
activities?
Are any externally provided activities used? Are the processes of ☐ ☐
these activities validated and audited?
Has the biobank defined the criteria for evaluation, selection, ☐ ☐
monitoring of performance and re-evaluation of the external providers
and have these requirements been communicated to the external
providers?

Agreements
(SFS-EN ISO 20387:2020, 7.3)
Has the biobank established a procedure for the control of ☐ ☐
agreements? Are the changes documented?
Collection, reception and distribution, transport, traceability, preparation, preservation and storage of
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INITIAL DESCRIPTION OF THE APPLICANT’S COMPETENCE 2/3

Kyllä Ei Viittaus
Yes No johtamisjärjestelmän
dokumentaatioon
Reference to the
managements system
documentation
biological material and associated data
(SFS-EN ISO 20387:2020, 7.2–7.7)
Is the collection of biological material documented? Are the ethical ☐ ☐
requirements e.g. relevant ethical approvals used (samples of human
origin)?
Are the procedures and acceptance criteria of the reception of the ☐ ☐
biological material and the associated data defined? Are they verified
upon acquisition/reception according to the defined acceptance
criteria? Is the fitness for the intended purpose associated with the
received or acquired biological material assessed?
When distributing biological material and/or associated data to a ☐ ☐
recipient/user, is the predefined information provided?
Are the procedures of transport of the biological material and the ☐ ☐
associated data in place and in use? Are the transports monitored?
When transferring the biological material are the agreements fulfilled?
Is the traceability of the biological material and associated data ☐ ☐
ensured?
Are the methods used for the preparation and preservation of the ☐ ☐
biological material standard methods and/or specified in agreement
with the provider/recipient/user? Are the critical activities monitored?
Is there a disaster protection plan with use of alternative methods of ☐ ☐
safeguarding to avoid loss of biological material? Are the procedures
of the storage defined and documented? Are the relevant processing
parameters measured, monitored and documented during the
execution of critical activities? Is the risk of contamination minimized
during the storage? Are there procedures supporting the patient/donor
right to withdraw consent for storage and use of biological material
and associated data established, documented and implemented?
Quality control and methods
(SFS-EN ISO 20387:2020, 7.8–7.9)
Has the biobank established procedures for monitoring the validity of ☐ ☐
activities?
Does the biobank monitor its performance by participating in ☐ ☐
proficiency testing or interlaboratory comparisons?
Has the biobank verified or validated the methods used? ☐ ☐
Management of information and data and reporting
(SFS-EN ISO 20387:2020, 7.10 ja 7.12)
Has the biobank ensured that the information management systems ☐ ☐
used for collection, processing, recording, reporting, storage and
retrieval of data are validated and protected from unauthorised access
and safeguarded against loss?
Does the biobank have procedures for reporting? ☐ ☐
Nonconforming output and complaints
(SFS-EN ISO 20387:2020, 7.11, 7.13, 8.7)
Does the biobank have procedures for handling nonconformities? ☐ ☐
Does the biobank have a documented process to receive, evaluate ☐ ☐
and make decisions on complaints from donors, users and/or other
interested parties and is the process description available for
everyone?

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Kyllä Ei Viittaus
Yes No johtamisjärjestelmän
dokumentaatioon
Reference to the
managements system
documentation
Management system
(SFS-EN ISO 20387:2020, 4.1, 5 ja 8)
Is the management system documented and are the documents ☐ ☐
identified and controlled?
Has the biobank defined and document the range of biobank activities ☐ ☐
for which it conforms with their standard requirements?
Has the biobank a governance body/advisory board guiding and ☐ ☐
advising management on scientific, technical and/or administrative
and other matters?
Does the biobank have personnel who have the authority and ☐ ☐
resources to maintain and improve the management system?
Has the risks and opportunities identified for associated with biobank ☐ ☐
activities?
Does the biobank have a policy and procedures for collecting and ☐ ☐
handling feedback from donors and/or users?
Does the biobank conduct internal audits at planned intervals, and do ☐ ☐
the planned internal audits cover the biobank activities?
Does the biobank conduct management reviews at planned intervals ☐ ☐
and does the planned management reviews cover the biobank
activities?

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