Internal Audit Report
"Date: "28-MAR-18 "
"To: "Luis Garcia "
"CC: " "
"From: " "
"Subject: "Internal Audit – Audit # TIJ-2018-MAR-001 "
" " "
"Scope: "An audit of the Labels VS was performed on 27-MAR-18 to DDMMAA by Liliana Hinojosa, Danira"
" "Navarro, Ruben Alonso as part of the scheduled quality audit program. "
"Standard " ISO 9001:2015 ISO 13485:2016 21 CFR 820 "
"Audited "Other _____________________________ "
"Summary: "The audit included review of Department Procedures, Forms and Training Records (described "
" "below): "
"The following documents were reviewed during the audit: "
" "
"Information was provided by the following individuals: "
"Javier Quevedo "
"Additional comments about the audit: "
" "
"Findings identified from the previous internal audit were reviewed: "
"Audit Number: " "
"Corrective actions were effective?"Yes No If no, explain: "
Nonconformances summary
"Major Nonconformance – It is a general failure of a procedure or requirement of the norm/standard. "
"Occurs when: "
"There is a total failure of a procedure or work instruction that is critical to product quality or in "
"the Quality System. "
"There is a total absence of any procedure required by the Standard. "
"There are several minor faults in the procedure, when added collectively suggest a total or "
"substantial failure in the procedure. "
"Minor Nonconformance – Is an isolated observation to a specific part of a process or Quality System. "
"Example: lack of follow up to a procedure in a specific manufacturing area. "