Application

FA 2061, Application for ISO 15189 Accreditation

Manual

MA 2100, Accreditation Manual for Laboratory-Related Activities

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

Accreditation Requirements

AR 2253, ISO 15189 Medical Test Laboratories

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

Administrative Process Rules

PR 1018, Policy on Use of ANAB Accreditation Symbols and Claims of Accreditation Status

PR 2301, Accreditation Status

Applies to all customers and provides definitions and specific administrative process for accreditation statuses.

PR 2303, Assessment Activities

The assessment process determines the customer’s compliance with the requirements of the relevant accreditation standards, ANAB accreditation requirements, and any supplemental requirements, and the technical competence to the scope of accreditation. Various activities are used, both on-site and remotely, to evaluate conformance. Assessment activities include all locations where key activities of the customer are performed.

PR 2305, Delays Caused by the Customer

Defines the process when, for whatever reason, a customer delays the accreditation process during the application or assessment stage, and applies to all applicant and accredited customers.

PR 2307, Multi-Site Accreditation

Defines ANAB's process to determine, apply, manage, and accredit multiple-facility organizations (main, satellite, and temporary), mobile, and on-site conformity assessment services of the customer.

PR 2308, Transfer of Accreditation

Defines ANAB's process when an accredited customer seeks to transfer accreditation to ANAB.

PR 2310, Fees and Travel

Defines assessment fees ANAB charges customers and the required travel requirements for ANAB assessors and technical experts.

PR 6000, Appeals and Complaints

Applies to all customers and stakeholders and provides administrative process rules for appeals and complaints.

Guidance Documents

 

Scopes of Accreditation

PR 2359, Preparing a Draft Scope of Accreditation for ISO 15189 Medical Laboratories

To assist in drafting scopes of accreditation and to clarify ILAC guidance documents and ANAB requirements, while helping standardize formats across the range of potential ISO/IEC 17020 accredited tests.

FM 2859, ISO 15189 Medical Test Laboratory Scope Template (contact ANAB)

Other Documents

FM 6001, Appeal Form

CL 2905.01, ISO 15189 General Accreditation Requirements Checklist (contact ANAB)

CL 2905.02, ISO 15189 Surveillance Assessment Checklist for SA1, SDR, SDA (contact ANAB)

CL 2905.03, ISO 15189 Surveillance Assessment Checklist for SA2 (contact ANAB)

CL 2905.04, ISO 15189 Scope Expansion Checklist (contact ANAB)

Change Notifications

FM 2830, Client Notification