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...
ISO 15189:2012 specifies requirements for quality and competence in medical laboratories.
ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and...
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 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 document replaces CAN-P-1625.
These guidelines apply to all assessments and reassessments conducted on behalf of SCC.
The document SCC Requirements and Guidance for Method Validation in Testing Laboratories replaces CAN-P-1629 PALCAN Guidance For The Validation Of Test Methods – November 2006.
This document...
The document SCC Requirements and Guidance for Calibration and Measurement Traceability in Testing Laboratories replaces CAN-P-1626:2011 Policy on Calibration and Measurement Traceability....
The document SCC Requirements and Guidance on the Use of Information Technology in Accredited Laboratories replaces CAN-P-1628 - PALCAN Policy on the Use of Information Technology in Accredited...