Note: The location and identification (name of procedure and paragraph number, where needed) of all applicable documentation must be indicated on the self-audit form. This will greatly expedite the audit and avoid the expense of additional audit days.
The supplier is encouraged to list in the audit scope, all of their applicable capabilities as related to Cable and Wire Harness manufacture. The Accreditation is based upon audit scope elements and will be published for all subscriber members.
Performing a thorough, objective self-audit against each question in the checklist is the critical first step in the MedAccred accreditation process. This phase is critical and will better prepare the supplier for the accreditation audit. Any nonconformances identified in the self- audit may be corrected prior to the accreditation audit.
Supplier must send either a hard copy or an electronic copy of the following to the assigned auditor, 30 days prior to the scheduled audit:
a) Original Self-Audit
The self-audit is to be completed with the related document name(s)/procedure number(s) marked next to checklist question where applicable.
b) Current QMS Quality manual (current copy which auditor will return to supplier on request).
c) List of Purchased/Outsourced Services
List of purchased services, including names(s) of supplier(s) for calibration, processing, testing, chemical analysis, etc.
d) List of applicable Industry Specifications
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