ISO 15189 – Documents and Resources

Explains the operational activities and responsibilities of ANAB and its customers (excluding forensics and management systems certification bodies).

Accreditation Requirements

Defines accreditation requirements for ISO 15189 medical test laboratories (non-forensics). To be used in conjunction with MA 2100.

Administrative Process Rules

Defines ANAB requirements as related to the accreditation process.

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

Scopes of Accreditation

Defines the requirements for the development and drafting of scopes of accreditation for ISO 15189 accreditations.