ISO 20387 Biobanking – Documents and Resources
Manual
Explains the operational activities and responsibilities of ANAB and its customers (excluding forensics and management systems certification bodies).
MA 2100, Accreditation Manual for Laboratory-Related Activities
Accreditation Requirements
Defines accreditation requirements for ISO 20387 Biobanking. To be used in conjunction with MA 2100.
Administrative Process Rules
Defines ANAB requirements as related to the accreditation process.
PR 1018, Policy on Use of ANAB Accreditation Symbols and Claims of Accreditation Status
PR 2303, Assessment Activities
PR 2305, Delays Caused by the Customer
PR 2307, Multiple Location Accreditation
PR 2308, Transfer of Accreditation
PR 2311, Flexible Scopes of Accreditation (non-forensic)
PR 2316, Remote Assessment Activities
Client Notifications
FM 2830, Client Notification – Administrative Change Request – This form is to be used by organizations that wish to request and/or provide notification of a change to location(s) including the name in which accreditation is held, authorized contacts, contact details, legal entity, Tax ID number. Where key personnel have changed, please complete the technical change request.
FM 2831, Client Notification – Technical Change Request – This form is to be used by organizations that wish to request and/or provide notification of a change to location(s), key personnel, scope of accreditation and unsatisfactory PT/ILC results.
Guidance Documents
ISO/TR 22758:2020, Implementation Guide for ISO 20387
Scopes of Accreditation
Defines the requirements for the development and drafting of scopes of accreditation for ISO 20387 accreditations.
PR 2262, Preparing a Draft Scope of Accreditation for ISO 20387 Biobanking