1、SCOPE

This checklist shall apply to suppliers seeking MedAccred accreditation who are engaged in the Cable and Wire Harness (CH) assemblies manufacturing process in accordance with the requirements of Class 2 or greater of the IPC/WHMA-A-620, and/or customer requirements. In addition to this accreditation audit process, certification also requires that the site’s quality management system has been verified.

The purpose of this Audit Criteria is to provide a means to verify and document that systems are in place to control the Cable and Wire Harness manufacturing process and that the supplier’s process procedures are being followed.

The MedAccred Cable and Wire Harness Task Group recognizes quality systems approvals as pre-requisite in accordance with PD1300. If the supplier has been audited and has an approved quality system in accordance with the requirements of PD1300, then no further assessment for quality systems will be required.

Although specific audit criteria for evaluation of the general quality system is not included within the text of this checklist, quality system requirements do form a part of the standard used in the MedAccred Cable and Wire Harness Accreditation program. As such, Auditors may identify and record nonconformances related to the quality system. The supplier must address these nonconformances in order to obtain MedAccred Accreditation；