posted 20 June 2001 03:34 PM               

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

posted 21 June 2001 09:28 AM               

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?

posted 21 June 2001 11:12 AM               

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)