Document / Record Archive Vendors (Suppliers)

J

jfount

Our Quality Department (Document control group) is trying to set up a Vendor audit with our Records Management Vendor.(Archive) During the process of providing our logistics group with a set of Aggressively filtered questions, they informed us there are no standards! or reuqirements that this Vendor needs to show Accreditation or registration for I.e. ISO? ANSII? FDA?

In fact the reponse from the vendor stated there is no such Accreditation or certification available for them. I have been looking up the various standards and it seems they may be right. I can not seem to find any requirments...Is this true? Is there anyone out there who knows anything on this subject.
Any help would be greatly appreciated
 
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Q

qualityboi

Re: Document / Record Archive Vendors

:D How about ISO 15489-1 International standard for Information and documentation - Records Management!
 
J

jfount

Does this cover requirements for accredidation?
I'll see if I can find it.

Thanks so much::thanx:
 

CarolX

Trusted Information Resource
Our Quality Departmnent (Document control group) is trying to set up a Vendor audit with our Records (archiving) Management Vendor. During the process of providing our logistics group with a set of Aggressively filtered questions, they informed us there are no standards! or reuqirements that this Vendor needs to show Accreditation or registration for I.e. ISO? ANSII? FDA?

Sorry if this is going to sound a little harsh -but....

Your vendor could be correct. In fact, it really is up to your company to define what you require of your suppliers, including a supplier that manages your records. To expect them to operate under a standard that you (as the customer) have not defined (or even know if one exist) is a failure on your part.

You may have some trouble going back to them and asking for them to sign up for ISO standard. You may need to have your supplier re-quote your work.
 
J

jfount

Unfortunately we are still somewhat of a young company by standards.
We have just in fact completed (2006) an approved vendor list.
The records management vendor was established through our logistics group previously more for financial and legal documentation. In the last year we started using them for our GMP documentation.

They are a well established Major company who provides this service to a majority of larger regulated companies.
Since I am responsible for managing the audit system and Approved Vendor list, I have scheduled an on site audit to this provider.

Although they are a recognized company in the industry they really don't have much of a quality system from what I can gather. I am at a loss as to how we could audit them without giving them a negative rating...There must be something they must have to provide this type of service.

Any more ideas?
 

Jim Wynne

Leader
Admin
Although they are a recognized company in the industry they really don't have much of a quality system from what I can gather. I am at a loss as to how we could audit them without giving them a negative rating...There must be something they must have to provide this type of service.
Why would you assume a negative rating before the audit? If you've established and communicated your requirements, per Carol's observations, then you can audit to see whether or not your requirements are being met. If you haven't established any requirements, there's nothing to audit.
 
A

Aaron Lupo

Although they are a recognized company in the industry they really don't have much of a quality system from what I can gather. I am at a loss as to how we could audit them without giving them a negative rating...There must be something they must have to provide this type of service.

Any more ideas?

Going in with that attitude the audit/visit is bound to be a miserable experience.

Have you asked them if they have any documented (internal) procedures they follow or are you just assuming because they do not have accreditation or registration to any standards they are not a quality organization?

Have you had any issues with this supplier in the past, what is the reason you are doing a site audit?

Just a couple of questions you may want to consider.
 
J

jfount

Hey folks, I just asked a question...Maybe I didn't explain it well enough.

The Vendor was brought in from our logistics group for financial and Legal documentation. They didn't consider Quality/GMP records. Our original GMP Archive Vendor was changed due to cost reductions with the new Vendor, again without any coordination, conversation, or recommendation from the quality group. (Gee I wonder if this happens to other companies?)

Now it's our job to get them put on the AVL. Part of that includes an Audit. Something that was never considered originally. My question was in regards to them needing to have any type of accreditation only.

Like I said we are a young company, Quality doesn't have a lot of support when it comes to $$$$
Thanks for all the input.

I like the Vendor already!
There is no negative attitude, just want to do it right!
 
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