Creating a "Records Policy" - Control of Quality Records

G

glenn0004

#1
Help!

I am trying to create a "records policy" for 9001:2008, does any one have any sugestions on what to include or stay away from - should I include "all" business records or just records relating to 9001:2008?????
 
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Jim Wynne

Staff member
Admin
#2
Re: Control of Quality Records

Help!

I am trying to create a "records policy" for 9001:2008, does any one have any sugestions on what to include or stay away from - should I include "all" business records or just records relating to 9001:2008?????
4.2.4 of ISO 9001:2008 says (in part):

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. (My emphasis)

That tells you which records need to be "established and maintained." Any record that doesn't fit either of those two criteria doesn't need to be included.

ETA: Welcome to the Cove!
 
J

JaneB

#6
Re: Control of Quality Records

Help!

I am trying to create a "records policy" for 9001:2008, does any one have any sugestions on what to include or stay away from - should I include "all" business records or just records relating to 9001:2008?????
If you're going to the effort of creating a policy (and presumably a procedure?? because that's required), it may well be worth covering records that aren't strictly required by 9001 (eg, who's responsible for storing financial records?) but are essential to your business. But that's purely an individual decision for each organisation to make.

Do keep it broad though, and don't aim to list each and every individual record, or you'll be here until next year creating it, let alone maintaining the damned thing.

Keep in mind the key points : ISO 9001 requires you (organisation) to know & manage:
1. What kinds of records you have
2. Who's responsible for them
3. That they're appropriately stored & managed, including kept confidential where needed, and protected (so they don't get wiped out by careless fingers on the Delete key f'rinstance)
4. That you can get 'em when you need 'em
5. When you no longer need 'em, you dispose of them suitably. (hence, retention periods & disposal methods).

And yes, it includes electronic records, backups etc, not just hardcopy.
 
W

WisdomseekerSC

#7
Re: Control of Quality Records

Does anyone have a reference to a list of required quality records for ISO 13485:2003 and QSR similiar to the Annex B referenced in this thread by Ajit?
 
W

WisdomseekerSC

#8
Re: Control of Quality Records

.....meanwhile, I created a list for ISO 13485:2003, see attached. Let me know if I missed anything.

Another question.... when each customer wants different retention times on records :(, is it permissible for us to set a manageable retention time to archive the records then, prior to disposal, contact the customer and give them the option of keeping the records longer themselves? :truce:Has anyone had success with this approach?
 

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Wes Bucey

Quite Involved in Discussions
#9
Re: Control of Quality Records

.....meanwhile, I created a list for ISO 13485:2003, see attached. Let me know if I missed anything.

Another question.... when each customer wants different retention times on records :(, is it permissible for us to set a manageable retention time to archive the records then, prior to disposal, contact the customer and give them the option of keeping the records longer themselves? :truce:Has anyone had success with this approach?
My company had a similar process, BUT we made the deal as part of the contract up front - i.e. our system was seven year retention; customers who demanded longer periods were told:
"We can accommodate your longer retention period in one of two ways:

  1. We can give you either originals or certified copies of the records with delivery of the product and you can retain them for as long as you choose
    or
  2. We can ship you all the original documents at the end of our normal retention period and you can do whatever you want with them.
In addition, we agree to ship the originals of any records pertaining to you [the customer] if we cease doing business for any reason prior to the end of the normal retention period."

Without exception, they were all happy to accept option #1, making the process very simple for everyone - we simply maintained our normal retention on everything and made our disposition decisions at the end of the retenion period without further consideration of the customer.

FWIW: very few customers even had retention clauses in their contracts and only a handful exceeded our own..
 
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