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....
 
Elsmar Forum Sponsor

Tallinec

Involved In Discussions
#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).
 
Thread starter Similar threads Forum Replies Date
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
K Internal Audits - Necessary before Stage 1 Audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 42
G Preparation Work for Internal Audit before they Audit a Area Internal Auditing 2
S Internal Audits required before Registration Audit - Distributors ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Y Internal Audits of All Facilities World Wide Before the Certification Audit Internal Auditing 9
R Internal Audit and Management Review before Certification: Is it a required? Management Review Meetings and related Processes 3
A Management Review and Internal Audits Before Registration Audit Management Review Meetings and related Processes 2
P US FDA QSR Internal Audit 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Outsourced Internal Audit requirements for Aerospace Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 21
D Number of people to be interviewed during an internal audit? Internal Auditing 6
Q Easy CARs for Internal Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
A Internal audit plan and processes for ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
C API Q1 internal audit report Internal Auditing 3
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 2
J Internal audit random sampling methodology Internal Auditing 2
G Organizing internal audit program for an Integrated QHSE Management System Internal Auditing 13
W How do you phrase your internal audit questions? Internal Auditing 3
M IATF - Internal Audit 3 year span Internal Auditing 4
Q ISO 9001-2015 Internal audit finding Internal Auditing 14
lanley liao How to understand this words that the planning of internal audit shall take into consideration the results of previous audits? Oil and Gas Industry Standards and Regulations 10
A Add MDSAP to Internal Audit Schedule Medical Device Related Regulations 0
J IATF 16949 Internal Audit question - Auditor's responsibility Internal Auditing 6
S IATF 16949 Internal Audit Example IATF 16949 - Automotive Quality Systems Standard 19
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 8
A Internal Audit Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
salaheddine96 Internal audit planning Internal Auditing 2
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
E MDR internal audit Internal Auditing 1
U Internal Auditor not trained but done Audit for some process Nonconformance and Corrective Action 5
B Looking for 10 Internal Audit Online Training Participants ISO 17025 related Discussions 2
H AS9100 Checklist for Internal Audit needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A What are the pros and cons of using an audit software for internal auditing? General Auditing Discussions 7
Q Internal audit plan template Internal Auditing 12
L Internal audit during COVID-19 restrictions ISO 13485:2016 - Medical Device Quality Management Systems 5
B Using Unreleased Documents & Process Maps for Internal Audit purposes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
N Small Company - Internal audit process - Who does the audit? Internal Auditing 16
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
G Addressing Non-Conformances from an Internal Audit that are not product related ISO 13485:2016 - Medical Device Quality Management Systems 11
S Internal audit discrepancy - We missed a few audits that were scheduled Internal Auditing 12
Raffy ISO 14001 9.2.2 Internal Audit Programme Content Internal Auditing 10
N Internal Audit Schedule – Who gets to set the schedule? Internal Auditing 16
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
G Non Conformance During ISO 9001 Audit - Not All Internal Audits Completed General Auditing Discussions 19
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
T Internal Audit Schedule when Hiring Out Internal Auditing 7
D ISO 9001:2015 Internal Audit Training Advice Internal Auditing 10
M Internal audit consultant ISO 13485 (English speaker) Consultants and Consulting 3
S Implementing a 45001 Health & Safety standard - Internal audit plan wanted Internal Auditing 1
F Internal Audit - Procedure example Internal Auditing 5

Similar threads

Top Bottom