Internal Audit before Pre-Assessment

fahimk

Involved In Discussions
#1
Dear Fellows,

I have following queries regarding Internal Audit for ISO 17025-2017:

1) Is it okay to conduct internal audit before initial pre-assessment? The accreditatin body is yet to visit us...

2) In my company internal audits are conducted annually and the activity is led by the centralized Quality Section (as per ISO 9001 and ISO 17020).
However, the quality section is not familiar with ISO 17025:2017. It's only the lab people who are conversant with ISO 17025.
Can i, as lab manager, conduct an in-house Internal Audit?
What steps will i need to demonstrate impartiality?
If not, what other options can i consider?


3) If there is no need to do internal audit before the accreditation visit, how can we demonstrate our competence on handling Non-Conformities (NCs)?

Thanks and looking forward....
 
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Tallinec

Starting to get Involved
#3
Dear Fellows,

I have following queries regarding Internal Audit for ISO 17025-2017:

1) Is it okay to conduct internal audit before initial pre-assessment? The accreditatin body is yet to visit us...

2) In my company internal audits are conducted annually and the activity is led by the centralized Quality Section (as per ISO 9001 and ISO 17020).
However, the quality section is not familiar with ISO 17025:2017. It's only the lab people who are conversant with ISO 17025.
Can i, as lab manager, conduct an in-house Internal Audit?
What steps will i need to demonstrate impartiality?
1)If an internal audit is not conducted before initial pre-assessment the auditing team (from accreditation body) is not able to check whether requirements of the standard about internal audit have been fulfilled. The same is in regard to top management review.

Read once more the list (received from accreditation body) of documents that you lab shall present to them before initial pre-assessment. I think, that an internal audit report is available in the list of documents to be submitted accreditation body.

2) An internal audit shall conduct a competent person. Requirements to competence of this person can be determined by an authorized person of your lab. Requirements to this person shall be documented. The same applies to all other functions of lab.

For example, an internal auditor can be a person who developed 25% of lab’s own procedures. Or a person who has skills in operating of 50% of lab’s works. Or a person who has 3 years experience in conducting internal audits in ISO 9001 or ISO 17020. The better way, that requirements to internal auditor shall not be limited to one of above mentioned examples, it shall be mix of ones.

To demonstrate impartiality you shall determine all risks of impartiality which are specific to your lab. Risks of impartiality are in a left column and actions to reduce or eliminate the risks are in a right column.

Examples:

In a left column: «Salaries of technicians depend on number of issued testing reports».
In a right column: “To add in labor contracts of technicians a provision that their salary does not depend on number of issued testing reports”.

or:

In a left column: “Owner of lab presses technicians to use obscure wording in testing reports”.
In a right column: “To add in labor contracts of technicians a provision that in professional activities they take orders only from the senior technician of lab”.

Impartiality is demonstrated by results of all risk assessment. A lab is acting impartially if all identified risks of impartiality are reduced to lowest possible level. Or eliminated (but I personally do not believe in 100% elimination of the risk).
 
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