posted 23 September 2000 01:00 AM               

From: Ralph Robinson [email protected]

"Ken Ensell" [email protected] enquired:

> Q: I have been told that for the 2000 version of 9001 only 6 procedures are
> required. Can anyone verify this ? How would the 20 elements be
> consolidated.
>
> I would really appreciate any help. Thanks in advance

In ISO\DIS 9001:2000 there are, in fact, only 6 specific call outs
for documentation. These are:

a) Clause 5.5.6 - Control of Documents:
"A documented procedure shall be established:" This is followed by 7 requirements for the procedure.

b) Clause 5.5.7 - Control of Quality Records:
"A documented procedure shall be established for the identification, storage, retrieval, protection, retention time, and disposition of quality records.

c) Clause 8.2.2 - Internal Audit
"A documented procedure shall include the responsibilities and requirements for conducting audits, ensuring their independence, recording results, and reporting to management."

d) Clause 8.3 - Control of Nonconformity
"These activities shall be defined in a documented procedure."

e) Clause 8.5.2 - Corrective Action
"The documented procedure for corrective action shall define requirements for:" This is followed by 6 requirements for the procedure.

f) Clause 8.5.3 - Preventive Action
"The documented procedure for preventive action shall define requirements for:" This is followed by 4 requirements for the procedure.

Now the gray areas.

There are a number of requirements that require outcomes, outputs, reviews, actions, etc. to be recorded. These are:

a) The output of quality planning activity must be documented.

b) Results of management reviews must be recorded.

c) Planning of realization processes must be documented.

d) Results of contract reviews and subsequent follow-up actions must be recorded.

e) Results of design/development reviews and subsequent follow-up actions must be recorded.

f) Results of design/development verification and validation activities and subsequent follow-up actions must be recorded.

g) Results of supplier evaluations and subsequent follow-up actions must be recorded.

h) Occurrences of loss, damage, or other damage conditions to customer property must be recorded and reported to the customer.

j) Where no standard for the calibration of measuring and monitoring devices exists, the basis used for calibration must be recorded.

Do these requirements suggest documented procedures may be needed? In some cases it would be difficult to satisfy the requirements of the standard without a documented procedure.

And, finally, the really vague guidance found in Clauses 4.1 - General Requirements and 4.2 - General Documentation Requirements.

Clause 4.1 states, "The organization shall establish, document, implement, maintain, and continually improve a quality management system in accordance with the requirements of this Internation Standard."

Clause 4.2 states, "The quality system documentation shall include:" This is followed by 2 requirements, which are then followed by 3 conditions that could affect the presence of documentation.

However, Section 4 of the standards is OUTSIDE that portion to which companies will be audited for compliance!

ARE YOU CONFUSED YET?

Hopefully the FDIS, which is due out in the very near future, will clear up this mess. If it doesn't, I can see many disputes between companies and their registrars over just what documentation is really needed.