江西省MedAccred AC8121电子电缆和线束组件的审核标准(5)

additional information. Note: The PRI Staff Engineers or MedAccred Cable and Wire Harness Task Group may, upon review, change the auditor's determination of a finding.

The following information needs to be accessible upon the auditor’s arrival on-site:

a) Schedules

Schedule of calibrations, preventative maintenance, environmental monitoring, production, internal audits, compliance audits, system accuracy tests, solution analysis, nonconforming product analysis, and management reviews.

b) Procedures

Applicable procedures required per the audit scope.

c) List of Customers

List of MedAccred customers for which supplier is approved.

d) Organization Chart with Names and/or Job Titles.

2.2.3 After the Audit

In accordance with MedAccred procedures, the supplier has 21 calendar days from the time the auditor submits the audit to submit a corrective action plan, identify effective dates for each NCR and when applicable, objective evidence. This response shall be entered directly into PRI’s Electronic Database. The response must address the root cause of the nonconformance, the immediate action taken to resolve the discrepancy and the actions taken or to be taken to preclude recurrence including other impacted areas due to the nonconformance.

PRI staff or the MedAccred Cable and Harness Task Group may, after review of the audit report, require additional information or may find cause to issue additional findings. Note: Final authority over the disposition of the audit report, acceptability of corrective actions and accreditation recommendation rests with the MedAccred Cable and Wire Harness Task Group.