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 2301, Accreditation Status

PR 2303, Assessment Activities

PR 2305, Delays Caused by the Customer

PR 2307, Multiple Location Accreditation

PR 2308, Transfer of Accreditation

PR 2310, Fees and Travel

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