To conduct ISO 17025 Internal Audit - Auditor Requirements

E

Elynn

#1
Hi Experts out there, I have a query. I have been working for 4 years in an accredited Lab (ISO 17025) and trained in requuirements & Understanding of ISO 17025. :rolleyes:
Recently, I have a business call to conduct Internal Audit for another affiliated Lab. However, I am only trained in ISO 9001:2000 Internal Audit. Am I qualitfied to conduct Internal Audit for ISO 17025? If yes, what do I have to provide in order to proof to independant third party auditor?:nope:
 
Elsmar Forum Sponsor
E

Elynn

#2
Qualified To conduct ISO 17025 Internal Audit??

Hi Experts out there, I have a query. I have been working for 4 years in an accredited Lab (ISO 17025) and trained in requuirements & Understanding of ISO 17025. :rolleyes:
Recently, I have a business call to conduct Internal Audit for another affiliated Lab. However, I am only trained in ISO 9001:2000 Internal Audit. Am I qualitfied to conduct Internal Audit for ISO 17025? If yes, what do I have to provide in order to proof to independant third party auditor?:nope:
 
Y

Yew Jin

#4
Re: Qualified To conduct ISO 17025 Internal Audit??

Scroll down this page and you will get the answer on the similar thread.:cool:
 
E

Elynn

#5
Re: To conduct ISO 17025 Internal Audit

Hi, thank you very much.
By the way, is there any ISO 17025 Internal Auditor Course available in Malaysia?
 
#6
I would suggest that the technical requirements of ISO/IEC 17025 would be a challenge for an internal auditor, if that person has only ISO 9001 experience/training.

Yes, the Management requirements are similar, but the actual audit of the Technical requirements for test/calibration really requires someone who has had experience in that discipline.

If your experience of a lab includes that, then you need nothing more. It will be obvious from your audit findings. If, however, you only audited the Management aspects, you will need some training & experience to do a full lab system audit.

Andy
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#7
First thing to determine is if the accrediting body of the affiliated lab has any opinion/policy/requirements regarding internal auditor qualifications.....if yes, then follow that.

If not, then the 9K auditor training is adequate for the concepts and for the QMS.....your experience in your field will allow you to audit that area, but if additional technical areas require audit, then you need someone who is trained and/or experienced for that field.....remember, to audit the technical areas, you do not have to be an expert, but you MUST have sufficient technical background in that field or dicipline to make technical judgments.

As for 17025 internal auditor training, find out from your accrediting body if they or another APLAC signatory off the training.....I suspect that either NATA or IANZ or HKAS will, but check to make sure.

Hope this helps.

Hershal
 
E

Elynn

#8
Again, thank you everyone for the opinions and advise.

Can I also be advised if anyone has experienced conducting ISO 17025 covering only the Technical Requirements, due to shifting of equipments location? Is this accepted or a full IA need to be covered?

If can be done, what if a Management non-conformance is discovered?
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#9
Audits can be broken up into technical and QMS.....so you could conduct the technical part of the audit and for example someone else can complete the quality side a week later.

If, during the technical portion, you find a management deficiency, write it. For example, if someone is responsible for conducting a test or calibration and has not received training then document that. If the calibration providers do not meet the requirements specified in Clause 5.6.2.1.1 (traceability, measurement capability, and competence) then that is actually documented under purchasing, with additional support coming from 5.6.2.1.1

Hope this helps.

Hershal
 
E

Elynn

#10
Thank you, Hershal.

I have encountered to conduct the QMS a week or so after the Technical. However, just only on the Technical and no intend to cover the QMS? Have you?
 
Thread starter Similar threads Forum Replies Date
P Can internal ISO 17025 Auditor conduct ISO 9001 Audit ISO 17025 related Discussions 7
P How to conduct ILCP (inter-laboratory comparison programme) to get ISO 17025 ISO 17025 related Discussions 3
M ISO 17025 Audit check list to conduct horizontal and vertical audits ISO 17025 related Discussions 10
A Do we have to conduct tests during internal audit of ISO 17025:2005? ISO 17025 related Discussions 8
M Knowledge of test methods in order to conduct an internal audit to ISO 17025? ISO 17025 related Discussions 3
J ISO 9001:2008 - Can I still conduct Internal Audits in my company? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Can I conduct Internal Audit for combined ISO 9001, ISO 13485 and ISO 14001? Internal Auditing 37
R How do I conduct my API Q1, ISO compliant internal audits? Internal Auditing 1
M How to conduct the first ISO 9001:2000 Internal Audit Internal Auditing 11
S Calibration requirements for ISO 9001:2000 - We do not conduct GRR studies General Measurement Device and Calibration Topics 12
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
M Informational US FDA Draft Guidance – Patient Engagement in Design and Conduct of Medical Device Clinical Investigations Medical Device and FDA Regulations and Standards News 0
B Is it necessary to conduct product audit of entire product which is manufactured in the company as per IATF IATF 16949 - Automotive Quality Systems Standard 4
C How frequent to conduct Clinical / Performance Evaluation? CE Marking (Conformité Européene) / CB Scheme 4
S Script of R software to conduct Nested GRR for Destructive Testing Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
S CMDCAS ISO13485 - Bilateral agreement with SAI global to conduct Certification Audits ISO 13485:2016 - Medical Device Quality Management Systems 7
S Conduct Customer Satisfaction Survey for every submitted Bid? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T Conduct a fractional factorial 2^13-5 experiment with Minitab Using Minitab Software 4
M Help me understand how to conduct a Chi Square Test Statistical Analysis Tools, Techniques and SPC 3
N How do I conduct Management Review Meetings? Management Review Meetings and related Processes 34
R Can our Supplier's Quality Mgr. conduct Supplier Audit on behalf of manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
F Tips, Guidelines and Checklist to conduct Audit of Supplier & Subcontractor Document Control Systems, Procedures, Forms and Templates 5
L How to conduct a Quality Audit based on ASME BPVC VIII-1 requirements Various Other Specifications, Standards, and related Requirements 4
Y FDA - Does anyone have conduct the validation on GR&R worksheet before? Qualification and Validation (including 21 CFR Part 11) 7
I Code of Ethics and Conduct wanted Document Control Systems, Procedures, Forms and Templates 3
C When is the Best Time to Conduct Internal Audits Internal Auditing 22
Q Tips on how to conduct a good Internal Audit Opening Meeting Internal Auditing 19
D How to conduct a Gage R&R on DC Tools to Torque Bolts Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
G How to conduct a Toy Recall (College Question) Customer and Company Specific Requirements 2
N How do I conduct Risk Management for my company? ISO 13485:2016 - Medical Device Quality Management Systems 7
K How to conduct a QCC project Misc. Quality Assurance and Business Systems Related Topics 2
N Tyvek Pouch Seal - Pressure needed to conduct Vacuum Seal Leak test? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J How to Write the Planned Interval to Conduct Internal Audit, Management Review, etc.. ISO 13485:2016 - Medical Device Quality Management Systems 3
R How to conduct the Threshold Test of Mobile Equipment specified in 3rd edition? IEC 60601 - Medical Electrical Equipment Safety Standards Series 35
S How to conduct Capability Analysis for this data? Statistical Analysis Tools, Techniques and SPC 12
K Can auditors freely conduct confidential interviews, or consent is necessary? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
M Do we need to conduct Vendor (Supplier) Evaluation? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
K When, whom, how to conduct hazard analysis of PRP?s, OPRP?s and CCP?s? Food Safety - ISO 22000, HACCP (21 CFR 120) 1
S Can a suspended CB still conduct Surveillance Audits? Registrars and Notified Bodies 4
J My mentors insist I use hotel's employee manuals and codes of conduct for my... Service Industry Specific Topics 3
somashekar Sustainability audit per EICC Supplier Code of Conduct Sustainability, Green Initiatives and Ecology 14
Marc Apple Enforces "Supplier Code of Conduct" After Child Labor Discovery After Work and Weekend Discussion Topics 13
B How to Conduct a Review of Customer Order (Contract Review)? Contract Review Process 5
V How many years of experience is needed to conduct the internal audit in my company? General Auditing Discussions 4
Sidney Vianna Can CB's (certification bodies) conduct internal and 2nd party audits? Registrars and Notified Bodies 12
G How to conduct internal audits? Internal Auditing 52
D How to practically-conduct, post production phase ISO 13485:2016 - Medical Device Quality Management Systems 1
S Multilevel Design in Minitab to conduct a DOE - 4 factors and each has 5 levels Design and Development of Products and Processes 4
F How to conduct CMMI appraisal Class C Software Quality Assurance 4
P How to conduct MSA for Rotation Balancing Tester Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1

Similar threads

Top Bottom