Outsourcing Records Storage - Compliance Aspects to be considered during Audits

A

Asant

#1
Hi:

Our company is in the process to contract an external company to storage our quality records. Can some one tell me which aspect do I need to take in consideration during the audit in order to be in compliance with ISO 9001 requirements.
 
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harry

Super Moderator
#2
Welcome to the Cove.

1. I moved your post to form a new thread.

2. What does your current procedures say about this area? Subjecting the external party storing your records to the same requirements should be good enough - provided your current procedures are acceptable to your auditors.
 

somashekar

Staff member
Super Moderator
#3
Hi:

Our company is in the process to contract an external company to storage our quality records. Can some one tell me which aspect do I need to take in consideration during the audit in order to be in compliance with ISO 9001 requirements.
Hi Asant.
Welcome to the cove.
In what form are your quality records ?
Paper ?
Look for storage capacity (space) to your long term requirement, safety in terms of prevention against fire and other types of destruction and controlled environment to prevent damage due to humidity and temperature , Indexing and retrieve-ability of your records within time.
Electronic ?
Look for storage capacity (Gb's) offered and expandable to your long term requirement, safety in terms of prevention against fire and other types of destruction and controlled environment to prevent damage due to humidity and temperature of the hardware resource used (backup methods for disaster management), Indexing and retrieve-ability of your records within time (mostly not an issue if they are technically competent.) .... add hardware maintenance steps taken to avoid crashes and loss of your records.
 
A

Asant

#5
Hi Harry.

Thanks for answer my question.

Our procedure does not include external parties, so I guess that I need to revise the SOP in order to include them. Do I need to describe the complete process or just to delineate that the document will be storage by an external party?
 

yodon

Staff member
Super Moderator
#6
Look for storage capacity (space) to your long term requirement, safety in terms of prevention against fire and other types of destruction and controlled environment to prevent damage due to humidity and temperature , Indexing and retrieve-ability of your records within time.
Electronic ?
To piggy-back off of Somashekar's excellent advise, I'll just add that, regarding fire (prevention), look also at fire suppression. If, for example, fire is suppressed by water (sprinklers), it may be as destructive to paper as the fire itself.
 

Helmut Jilling

Auditor / Consultant
#7
Hi Harry.

Thanks for answer my question.

Our procedure does not include external parties, so I guess that I need to revise the SOP in order to include them. Do I need to describe the complete process or just to delineate that the document will be storage by an external party?
I would address at least the high points. If you don't, your auditors will repeatedly ask the same questions of controls, considerations, etc.

Whether stored internally or externally, the ISO requirements from cl 4.2.4 still apply.
 
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