Re: ISO 13485 Internal Audit questions How would you correlate them,
Here is a generic Internal Audit questions we found needed to be answered,...
How would you correlate for, or group the elements for an Internal Audit.?
This is my correlation of them and we can always
combine them as needed.
(1) Audit Q Clause 4.4.1 thru. 4.2.4
(2) Audit Q Clause 5.0 thru. 5.4.2
(3) Audit Q Clause 5.5 thru. 5.6.3
(4) Audit Q Clause 6.0 thru. 6.4
(5) Audit Q Clause 7.0 thru. 7.3.1
(6) Audit Q Clause 7.3.2 thru. 7.3.7
(7) Audit Q Clause 7.4 thru. 7.6
(8) Audit Q Clause 8.0 thru. 8.5.3
THANK YOU
An internal audit should really be based on the processes of the QMS, not the elements of the standard. If you only do this, you may raise the eyebrow of an effective CB auditor and also receive a non-conformity...
Here is a generic Internal Audit questions we found needed to be answered,...
How would you correlate for, or group the elements for an Internal Audit.?
This is my correlation of them and we can always
combine them as needed.
(1) Audit Q Clause 4.4.1 thru. 4.2.4
(2) Audit Q Clause 5.0 thru. 5.4.2
(3) Audit Q Clause 5.5 thru. 5.6.3
(4) Audit Q Clause 6.0 thru. 6.4
(5) Audit Q Clause 7.0 thru. 7.3.1
(6) Audit Q Clause 7.3.2 thru. 7.3.7
(7) Audit Q Clause 7.4 thru. 7.6
(8) Audit Q Clause 8.0 thru. 8.5.3
THANK YOU