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Author Topic:   Access to records
dbulak
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Posts: 16
From:usa
Registered: Aug 2000

posted 20 June 2001 01:28 PM     Click Here to See the Profile for dbulak   Click Here to Email dbulak     Edit/Delete Message   Reply w/Quote
I am looking for information (terminology) on how to handle who specifically has access to certain records. For example, certain people have access to some records and some have access to all records. Does this have to be specifically spelled out or are there "general" statements that can be made?

Any help would be appeciated.

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Jim Biz
Forum Wizard

Posts: 275
From:ILLINOIS
Registered: Mar 2000

posted 20 June 2001 03:34 PM     Click Here to See the Profile for Jim Biz   Click Here to Email Jim Biz     Edit/Delete Message   Reply w/Quote
We use a matrix sheet with the headings
Element/Record number/custodian/indexed by/ accessed by/ stored in (location)/ retained time - legnth / disposition.

The wording in 9000:2000 section 4.2.4 "who has access - but it does state the procedure shahll "define controls needed".

Hope this helps
Regards
Jim

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E Wall
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Posts: 45
From:Columbus, GA USA
Registered: Jun 2001

posted 21 June 2001 09:28 AM     Click Here to See the Profile for E Wall   Click Here to Email E Wall     Edit/Delete Message   Reply w/Quote
quote:
Originally posted by Jim Biz:
The wording in 9000:2000 section 4.2.4 "who has access - but it does state the procedure shahll "define controls needed".

Now I'm confused. In Section 4.2.4 of 9001:2000 I do not find any wording or reference regarding 'who has access'.

Unless your management locks you into defining such (and I'd have to ask what benefit would there be?) I would get rid of it.

We also keep a database of what records are kept, as well as identifying who is responsible for collection/retension of these documents. I would be happy to offer a copy of our work instruction. I have no plans of modifying it for 2000 revision.

Using the Auditor Checklist received from our Registrar these are the questions they will be looking for answers on:

1) Have records been established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system?
and,
2) Has a documented procedure been established to define the following controls needed?
a. identification?
b. storage?
c. retrieval?
d. protection?
e. retention time?
f. Disposition?

If there is something I am missing please let me know , I'd hate to be caught unaware.

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Jim Biz
Forum Wizard

Posts: 275
From:ILLINOIS
Registered: Mar 2000

posted 21 June 2001 11:12 AM     Click Here to See the Profile for Jim Biz   Click Here to Email Jim Biz     Edit/Delete Message   Reply w/Quote
Sorry for the confusion

9001:2000 Does NOT specifically state ãWho has accessä just that they be controlled
However, implement guide 9004 pg. 3 under 4.2 says Access to docs ãShouldä be ensured···. based on
Communication policy.

We took a minor hit ö on this issue under 1994 version because we had not included ãAccessed by.ä
In our procedure and had not identified ãWho had responsibility for release of doc/data information to customers. (In 4.16 and in 4.11)

Regards
Jim

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