SCC Accreditation Program for Medical Laboratories Requirements Procedures
Accreditation requirements
The following is a listing of requirements and procedures documents required by SCC Accreditation programs for Medical Testing Laboratories:
ISO/IEC 17000 defines accreditation as “third-party attestation (5.2) related to a conformity assessment body (2.5) conveying formal demonstration of its competence to carry out specific conformity...
This document provides applicant laboratories, accredited laboratories and assessment teams with guidance about the interpretation of the verification and validation requirements for non-standard...
This document sets out the requirements for, and gives guidance to, laboratories and SCC assessment teams on the use of PT activities in the accreditation process of laboratories. It also aims to...
This International Standard, based upon ISO/IEC 17025 and ISO 9001, specifies requirements for competence and quality that are particular to medical laboratories1. It is acknowledged that a country...
ISO 15190:2003 specifies requirements for safe practices in the medical laboratory.
ISO 22870:2016 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189. The requirements of this document apply when POCT is carried...
CSA Z902 provides management requirements for facilities that collect, process, store, and use human blood components for transfusion. It addresses issues of safety, efficacy, and quality for...
This document replaces CAN-P-1625.
These guidelines apply to all assessments and reassessments conducted on behalf of SCC.
The SCC Requirements & Guidance on the Use of Information Technology in Accredited Laboratories is withdrawn effective October 1, 2020. If you need a copy of the document for references...