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?(cos 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?(cos 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
ISO Coordinator. Since you are heading one department i.e. HR, you are required to maintain your own files as listed
in List of Records. Any findings by external auditor and replies thereof is the responsibility of MR and ISO coordinator will
maintain such files and reply sent in time. The replies to auditor's findings will be reviewed by 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 auditor. Since you are heading only one department it would be suffice you maintain
your own files and corrective actions of your department in your audit file only. The same matter is also available with ISO
coordinator in his CAPA file. You have to maintain all the audit related matters including CAPA pertaining to your HR dept. only
with you. You need not maintain other departments audit related matters. You have to maintain audit file separately as listed
in LOR. If you need any further clarification, you can reach me at:
D. SUBBA RAO
From India, Visakhapatnam
ISO Coordinator. Since you are heading one department i.e. HR, you are required to maintain your own files as listed
in List of Records. Any findings by external auditor and replies thereof is the responsibility of MR and ISO coordinator will
maintain such files and reply sent in time. The replies to auditor's findings will be reviewed by 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 auditor. Since you are heading only one department it would be suffice you maintain
your own files and corrective actions of your department in your audit file only. The same matter is also available with ISO
coordinator in his CAPA file. You have to maintain all the audit related matters including CAPA pertaining to your HR dept. only
with you. You need not maintain other departments audit related matters. You have to maintain audit file separately as listed
in LOR. If you need any further clarification, you can reach me at:
D. SUBBA RAO
From India, Visakhapatnam
But in most of the organizations MR (Top position) employee in the organization as defined by the standard. MR just review and relies mostly on the ISO coordinator / DY MR because of his work exingenesis. Formal communication with certification body should be done by MR Only. But onething is good move after audit, one should initiate in closing and collecting evidences for CAPA from various functions in the organization. As per 2015 version of QMS and EMS changes are there.
Narayan
From India, Hyderabad
Narayan
From India, Hyderabad
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