ISO 15189 – 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 15189 medical test laboratories (non-forensics). To be used in conjunction with MA 2100.
AR 2253, ISO 15189 Medical Test Laboratories
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
GD 2701, Guidance on Corrective Action and Cause Analysis
GD 2703, Guidance on Purchasing and Evaluation Calibrations
GD 2704, Guidance on Internal Audits for Laboratories
GD 2705, Guidance on Management Review for Laboratories
GD 2706, Guidance on Writing Standard Operating Procedures
GD 2707, Guidance on Uncertainty of Measurement for Testing Laboratories (non-forensic)
GD 2708, Guidance on Purchasing and Evaluating Reference Materials
Scopes of Accreditation
Defines the requirements for the development and drafting of scopes of accreditation for ISO 15189 accreditations.
PR 2253, ISO 15189 Medical Laboratories Program Scoping Requirements