Relative Elements to Audit

M

Mark Smith

#1
#1
I have redesigned my audit schedule so that it includes a column that identifies what elements from ISO 9001 will be audited against for each function identified on the schedule. For example, next to Manufacturing I have Elements : 4.3., 4.5., 4.6., 4.8., 4.9., 4.10., 4.11., 4.12., 4.13., 4.15., 4.17., 4.18., 4.20. to be audited. However, for the functions: Purchasing, Administration and Sales, I only list 4.16 and 4.18 plus 4.6 for Purchasing. Am I missing something? I just don't see anything relevant from the other elements for these functions.
 
QMS for Life Sciences
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L

lyman

#2
#2
Our audit schedule also includes the following elements for all manufacturing and support groups:

4.1 and 4.2 - to gauge how information is flowing up and down through the chain, and determine the involvement level of the management personnel in the QMS

4.5 - to make sure that they are following internal Document Systems requirements

4.14 - to review internal preventive and corrective action processes for effectiveness, and try to determine the level of on-going continuous improvement activities
 
A

Alf Gulford

#3
#3
Mark-
If we're defining Sales the same way, paragraph 4.3, Contract Review, is very important, both in terms of the initial sales information and how they handle any subsequent changes.

Just a thought.

Alf
 
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