ISO Records. As an HR executive, I am also part of the ISO (Quality Management System) team. The person handling it had to leave suddenly, and I am supposed to maintain the records now. He maintained a file (hard copy) for audit records, but only internal audit records (for the last two years) were filed. The external audit for 2015 is over, and the corrective actions are completed now.
Can anyone suggest if I can include this CAPA record in the internal audits file itself as a new addition and practice? (because the previous external audit records I am unable to find in this file).
Thanks, Swapna
From United%20Arab%20Emirates, Abu%20Dhabi
1Can anyone suggest if I can include this CAPA record in the internal audits file itself as a new addition and practice? (because the previous external audit records I am unable to find in this file).
Thanks, Swapna
From United%20Arab%20Emirates, Abu%20Dhabi
In any company certified under ISO, there will be one MR, Dy. M.R., and ISO Coordinator. Generally, all files will be maintained by the ISO Coordinator. Since you are heading one department, i.e., HR, you are required to maintain your own files as listed in the List of Records. Any findings by an external auditor and replies thereof are the responsibility of MR, and the ISO coordinator will maintain such files and reply sent in time. The replies to the auditor's findings will be reviewed by the auditor, and we have to show the proof in the ensuing audit. All corrective actions for the observations/non-conformities will be replied duly consolidated by MR/ISO coordinator and sent to the auditor. Since you are heading only one department, it would suffice if you maintain your own files and corrective actions of your department in your audit file only. The same matter is also available with the ISO coordinator in his CAPA file. You have to maintain all the audit-related matters, including CAPA pertaining to your HR department only with you. You need not maintain other departments' audit-related matters. You have to maintain the audit file separately as listed in LOR. If you need any further clarification, you can reach me at 
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D. SUBBA RAO
From India, Visakhapatnam
D. SUBBA RAO
From India, Visakhapatnam
In most organizations, the MR (Top position) employee is defined by the standard. The MR primarily reviews and relies on the ISO coordinator / DY MR due to their extensive experience. Formal communication with the certification body should be conducted solely by the MR. One positive step to take post-audit is initiating the closure process and gathering evidence for CAPA from various functions within the organization. The 2015 version of QMS and EMS reflects some changes.
Narayan
From India, Hyderabad
Narayan
From India, Hyderabad
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