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Accreditation scope for

BIO 001

Folkehelseinstituttet

Avdeling for biobanker

Postboks 222 Skøyen,
0213 Oslo

Telephone: 21077000
E-mail: Biobank@fhi.no
Internet: https://www.fhi.no/om/organisasjon/biobanker/
The laboratory meets the requirements in

EN ISO 20387:2018




Accreditation includes:
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The administrative / geographical unit:
Avdeling for biobanker
Myrens Verksted 6H
0473 Oslo


Permanent facility
BIO1 Human material
Material
Activity
Storage conditions
Method
Internal method identity
Object
DNA
Parameter
Testing and control of incubator cabinets
Comment
Reference standard
Internal method
Internal method identity
08-SOP-001
Object
DNA
Parameter
Testing and control
Comment
-20°C
Reference standard
Internal method
Internal method identity
08-SOP-046
Object
DNA
Parameter
Manual sample handling
Comment
-20°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-028
Object
DNA
Parameter
Automated sample handling, preservation, and control
Comment
-20°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-029
Object
DNA
Parameter
Automated sample handling and control
Comment
-20°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-030
Object
DNA
Parameter
Preparation and storage
Comment
-20°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-007
Object
DNA
Parameter
Automated preparation
Comment
-20°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-063
Object
DNA
Parameter
Preparation (with kit)
Comment
-20°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-052
Object
DNA
Parameter
Automated preparation, testing, and control
Comment
-20°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-035
Object
DNA
Parameter
Testing
Comment
-20°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-040
Object
Whole blood
Parameter
Collection (project specific)
Comment
-80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-026
Object
Whole blood
Parameter
Labelling and registration
Comment
-80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-002
Object
Plasma
Parameter
Standard preparation
Comment
-80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-054
Object
Plasma
Parameter
Preparation (project specific)
Comment
-80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-044
Object
Plasma
Parameter
Automated sample handling, preservation, and control
Comment
-80°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-031
Object
Plasma / urine
Parameter
Testing and control
Comment
-80°C
Reference standard
Internal method
Internal method identity
09-SOP-017 09-SOP-018
Object
Plasma/Serum
Parameter
Preparation
Comment
-80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-001
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Labelling and preparation of trays
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-028
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
File management
Comment
Reference standard
Internal method
Internal method identity
07-BEH-SOP-029
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Automated distribution lists
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-035
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Information management
Comment
Reference standard
Internal method
Internal method identity
07-UTT-SOP-036
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Testing and control of distribution
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-057
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Manual registration, labelling, and preparation
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-049
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Collection of data
Comment
Reference standard
Internal method
Internal method identity
07-BEH-SOP-067
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Sample handling
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-GEN-SOP-016
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Standard initiation of distribution
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-037
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Return of distribution
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-040
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Testing and control of labelling
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
09-SOP-024
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Data distribution and information management
Comment
Reference standard
Internal method
Internal method identity
12-SOP-001
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Manual sample handing and distribution
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-006
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Initiation of distribution (project specific)
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-009
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Control of distribution
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-010
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Information management during distribution
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-014
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Automated distribution
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-027
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
HSE, logistics, and sample handling
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-027
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Destruction beyond legal requirements
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-033
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Storage
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-036
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Freezer handling
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-GEN-SOP-030
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Allocation of responsibility for freezer operation and maintenance
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
08-SOP-034
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Distribution
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-001
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Data management for traceability
Comment
Reference standard
Internal method
Internal method identity
Datahåndtering for sporbarhet
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Data management
Comment
Reference standard
Internal method
Internal method identity
07-GEN-SOP-032
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Freezer compression
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-003
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Maintenance and inspection of chest freezer
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-004
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Destruction
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-005
Object
Plasma/Serum/ Whole blood /DNA
Parameter
Manual sample and data handling during distribution
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-UTT-SOP-002
Object
Plasma/Serum/Whole blood
Parameter
Preparation (project specific)
Comment
-80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-046
Object
Plasma/Serum/Urine /Whole blood
Parameter
Collection (preparation)
Comment
Reference standard
Internal method
Internal method identity
07-BEH-SOP-025
Object
Plasma/Serum/Urine /Whole blood/DNA
Parameter
Sample reception
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-013
Object
Plasma/Serum/Urine/ Whole blood
Parameter
Registration, labelling, and preparation
Comment
Reference standard
Internal method
Internal method identity
07-BEH-SOP-003
Object
Plasma/Serum/Urine/ Whole blood
Parameter
Problem solving by automated preparation
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-038
Object
Plasma/Urine/ Whole blood
Parameter
Dispatch of labelling materials (project specific)
Comment
-80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-061
Object
Urine
Parameter
Standard preparation
Comment
-80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-062
Object
Urine
Parameter
Preparation (project specific)
Comment
-80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-050
Object
Urine
Parameter
Collection (project specific)
Comment
-80°C
Reference standard
Internal method
Internal method identity
07-BEH-SOP-022
The administrative / geographical unit:
Lindern
Lovisenberggata 8
0456 Oslo


Permanent facility
BIO1 Human material
Material
Activity
Storage conditions
Method
Internal method identity
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Destruction beyond legal requirements
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-033
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Storage
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-036
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Freezer handling
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-GEN-SOP-030 08-SOP-034
Object
Plasma/Serum /Urine/ Whole blood/DNA
Parameter
Sample handling
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-GEN-SOP-016
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Freezer compression
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-003
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Maintenance and inspection of chest freezer
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-004
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
Destruction
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-005
Object
Plasma/Serum /Urine/ Whole blood /DNA
Parameter
HSE, logistics, and sample handling
Comment
-20°C, -80°C
Reference standard
Internal method
Internal method identity
07-LAG-SOP-027