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Explains the operational activities and responsibilities of ANAB and its customers (excluding forensics and management systems certification bodies).
Defines accreditation requirements for ISO 15189 medical test laboratories (non-forensics). To be used in conjunction with MA 2100 (see Manuals above).
Applies to all customers and provides definitions and specific administrative process for accreditation statuses.
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.
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.
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.
Defines ANAB's process when an accredited customer seeks to transfer accreditation to ANAB.
Defines assessment fees ANAB charges customers and the required travel requirements for ANAB assessors and technical experts.
Defines requirements and makes recommendations for conducting remote assessments.
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 15189 accredited tests.
FM 2859, ISO 15189 Medical Test Laboratory Scope Template (contact ANAB)
CL 2905.01, ISO 15189 General Accreditation Requirements Checklist (contact ANAB)
CL 2905.02, ISO 15189 Surveillance Assessment Checklist for SA (contact ANAB) - RETIRED
CL 2905.04, ISO 15189 Scope Expansion Checklist (contact ANAB)