amanbhai
25th May 2009, 02:44 AM
Last week we have been audited externally by the accreditation body. One of the NCs is our record is not controlled! I am also an auditor and want to know the specific requirement, auditor mentioned the nonconformance against 4.3 of ISO 17025:2005. I am not satisfied.
For my our learning and increase competence and understanding, any comment or assistance is appreciated.
:thanks:
Ted Schmitt
25th May 2009, 03:52 PM
What was the exact wording the auditor used?
Which record is not controlled? Do you have it identified that it needs control and did not control it or was it a record that the auditor thought best to be controlled?
Are you the only one not agreeing with the auditor or is your management also not agreeing?
dQApprentice
26th May 2009, 01:01 AM
If it did not meet the requirements, an explanation of where it did not and what actions are necessary for it to meet them should come from the auditor and discussed with personnel involved. Ideally, the closing meeting offers an opportunity to reach the auditee through direct verbal communication prior to final written report.
amanbhai
26th May 2009, 01:43 AM
What was the exact wording the auditor used?
Which record is not controlled? Do you have it identified that it needs control and did not control it or was it a record that the auditor thought best to be controlled?
Are you the only one not agreeing with the auditor or is your management also not agreeing?
the exact working are "Some quality documents like preventive matintenance plan 2009, lab staff list (for training on measurement uncertainty, dated:23-04-2009) and trainings schedule of lab personnel for year 2009 are not controlled."
We did identified some of the records. however, all records are not identified for controlling.
We the management has reservation about this finding.
Hershal
30th May 2009, 03:33 AM
The finding may or may not be justified, but I would have documented it against Clause 4.13.1 or 4.13.2 (Quality Records or Technical Records).
The forms would be documented against Clause 4.3 in my opinion.
AndyN
30th May 2009, 09:19 AM
the exact working are "Some quality documents like preventive matintenance plan 2009, lab staff list (for training on measurement uncertainty, dated:23-04-2009) and trainings schedule of lab personnel for year 2009 are not controlled."
We did identified some of the records. however, all records are not identified for controlling.
We the management has reservation about this finding.
You appear to be confusing the control of documents with the control of records. From what has been written, this is clearly a non-conformity, since each of these is a document, not a record.
Having reservations appears (at least to me) to come from a lack of complete understanding of the requirements at your organization, not due to a poor non-conformity statement by the external auditor.
You might want to take this as an opportunity to learn more about your system and how it complies with ISO/IEC 17025.
amanbhai
2nd June 2009, 03:44 AM
Yes, this NC has given me the oppertunity to learn my systems as well the ISO 17025.
I am still learning my system.