Medical and Administration department Document and Record Retention policy

M

MaryJames

#1
hellooo,
My company is going for ISO 9001 certification of its Medical and Administration department. We donot have any retention policy inplace. Every department have their own rules for storing the document. How do I satisfy Section 4.2.4 of the standard. Is it possible that I make a list of the documents assign the rights to departments head to define retention time of each document at the time of creation. Any suggestions.
Thanks in advance
 
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SteelMaiden

Super Moderator
Trusted Information Resource
#2
Re: Document and Record Retention policy

Are these like type documents? i.e. are we talking medical records for patients, but some depts don't keep them as long as others? Every document can have a different retention time. But, someone somewhere needs to be responsible for ensuring they are retained for the proper time. Yes, each dept. can have its own record person.
 
A

Amaterasu

#3
Re: Document and Record Retention policy

MaryJames:


You can add to your procedure a clause that may say:

"Records are maintained according to process requirements and owner's needs".

And you can request that each process owner, depending of their processes, the time of retention and storage of their records to be described at procedures and work instructions that generate records.

Regards,


Alfredo Ugalde

:tg:
 
S

sal881vw

#4
Re: Document and Record Retention policy

MaryJames
Most departments would still need to access their records for various reasons so it would be ideal to have the records at hand.Ensure that there is adequate storage facilities and that records are easily retrievable, plus the archiving process is documented and controlled.

I hope to have been of some help.
 
#5
Re: Document and Record Retention policy

MaryJames:

Depending where you are located, your organization might have to consider regulatory/statutory (federal and state) customer or your own organization's requirements for keeping records. If you have a legal advisor, I'd suggest you ask them, first. Sometimes just allowing individuals to to decide what to keep is risky. Also, resumes are only what people claim - not always what they actually have in terms of qualifications (yes, people 'enhance' their resumes):mg:
 

SteelMaiden

Super Moderator
Trusted Information Resource
#6
Re: Document and Record Retention policy

Good catch, Andy, for some of us, this just becomes so much a part of our every day existence that we forget others may not think about it. I'd think there would be plenty of legal requirements in a medical field. Also, if you are a part of a larger org, there may be some corporate requirements.
 
M

MaryJames

#7
Thank you guys for your quick and informative responses!!! I am trying to contact the legal and finance department to know about the requirements. But if they dont give a proper response, then I am planning to add a cluase in my procedure that a responsible person from the department will carry out the activity of coordinating with Department Head and other necessary functions and will write retention period.
Well I am still more confused as I made a Forms master List where I identified all the documents and forms related to processes, where are they kept and their retention period. Do you think I need to make a separate Record List as well because i cant possibly name all the records, the naming will be by form name (Right). Hope you guys understand what I am trying to imply.
 
A

Amaterasu

#9
MaryJames:


I presume that you want to keep traceability of every record generated by procedures or work instructions.

Try to keep it smooth and simple by reviewing your records control procedure.

When I worked at a construction project for a power supply plant for my goverment, we used to have a room to keep all manuals, procedures and work instructions - like a library - to keep all of our documentation ready at hand and safe.

I think it will ease your pain of control and storage. It's up to you to determine the access to your company's documentation keeping in mind accessibility and confidentiality.

Regards,


Alfredo Ugalde.

:tg:
 
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