ISO Records.
As a HR executive, I am a part of ISO(Quality Management System) team aswell. The person handling it had to leave suddenly and I am supposed to maintain the records now.There is a file(Hard Copy) that he had maintained for audit records,but only internal audit records(Last 2 years) are filed.External audit for 2015 got over and the CORRECTIVE ACTIONS are competed now.
Can any one 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)

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:


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.

From India, Hyderabad

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