QUERIES On ISO 17025 AUDIT - Measurement Uncertainty Budget, etc.

N

neo_inst

#1
Hi ,


I have an 17025 Audit coming next week n i have loads of queries and would be grateful if anyone could answer them

first of all , we have sent our QM, UNcertainty budgets etc to the Auditors and as of now they havent asked for any changes to be done (atleast in case of uncertainty ) DOES IT MEAN OUR UNCERTAINTY BUDGET IS OK ?

1) What can i expect in an Audit from Uncertainty point of few .. I mean how important is uncertainty VALUE.. coz there cannot be a right/ wrong answer .. there is a possibility that i could have not have considered some factors since i believe a factor of k=2 is a Huge number and would take into account some of the factors.

2) What is the Auditor going to ask regarding Uncertainty..i mean is he going to get into statistics or just the way i have come up those values..

3) Now in :( worst case is he going to FAIL me on the basis of uncertainty ? !!

PLease do let me know any other points i need to pay attention to before the Audit from 17025 point of view

Regards
Neo :bigwave:
 
Elsmar Forum Sponsor
R

Ryan Wilde

#2
Re: QUERIES On 17025 AUDIT !! ..uncertainty etc

neo_inst said:

Hi ,


I have an 17025 Audit coming next week n i have loads of queries and would be grateful if anyone could answer them

first of all , we have sent our QM, UNcertainty budgets etc to the Auditors and as of now they havent asked for any changes to be done (atleast in case of uncertainty ) DOES IT MEAN OUR UNCERTAINTY BUDGET IS OK ?
First off, good luck! The assessor will not tell you there is something wrong with your uncertainty budget until he/she sees your process. Each uncertainty budget is entirely reliant on how you do things, what you use, etc. I can say, with relative certainty, that you will have to change some of your budgets.

1) What can i expect in an Audit from Uncertainty point of few .. I mean how important is uncertainty VALUE.. coz there cannot be a right/ wrong answer .. there is a possibility that i could have not have considered some factors since i believe a factor of k=2 is a Huge number and would take into account some of the factors.
The uncertainty value is very important, as it is a quantitative representation of your capabilities. There are no absolutely right answers, but there are wrong ones. ;)

2) What is the Auditor going to ask regarding Uncertainty..i mean is he going to get into statistics or just the way i have come up those values..
The auditor will actually go through your budget with you, including the statistics.

3) Now in :( worst case is he going to FAIL me on the basis of uncertainty ? !!
In the U.S.A., you never "fail". You will have discrepancies that you will have to correct before you actually are accredited, but they are almost always things that you mail proof to the accrediting body. Rarely, the assessor may have to return to ensure that something is corrected, but I haven't seen it personally.

PLease do let me know any other points i need to pay attention to before the Audit from 17025 point of view.
Make sure that your methods are sound, and if you wrote them yourself, make sure that they are validated. 75-80% of your assessment will be on competency. This is no ISO 9000 audit, and the documentation aspect is not paramount. This is a competency assessment, and expect your assessor to ask a lot of questions such as "Why do you measure this in this manner?", and "What are the contributions to your uncertainty in this test setup?", and so on.

Again, good luck!

Ryan
 
Thread starter Similar threads Forum Replies Date
S Queries of new version ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
B Six ISO 13485 Queries Other ISO and International Standards and European Regulations 6
H Queries: RFD & Pre-RFD Program Medical Device and FDA Regulations and Standards News 0
M Multiple Standard Interpretation Queries Occupational Health & Safety Management Standards 4
P General queries on TS 16949 Registration - Software Services IATF 16949 - Automotive Quality Systems Standard 9
H Attribute Data Gage R&R - Queries of data from a system Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 19
A Queries about Element no 5.5.1 and 7.5.2 - Designation of "Authority" Design and Development of Products and Processes 11
L "Document Controlling" Queries run to obtain information reported to customer Document Control Systems, Procedures, Forms and Templates 7
A Where can I get information to answer queries realted to OHSAS 18001? Occupational Health & Safety Management Standards 1
N UNcertainty Queries !!!PLease reply ! Measurement Uncertainty (MU) 5
A Scope of ISO 13485 certificate ISO 13485:2016 - Medical Device Quality Management Systems 1
A ASL requirement when the supplier is certified for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 12
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 2
K Medical Device Repairs and ISO Scope ISO 13485:2016 - Medical Device Quality Management Systems 3
K Software Updates in the Field and ISO scope ISO 13485:2016 - Medical Device Quality Management Systems 0
M ISO 13485-2016 online certification ISO 13485:2016 - Medical Device Quality Management Systems 3
Z Auditor Findings ISO 14001:2015 vs. 45001:2015 ISO 14001:2015 Specific Discussions 5
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
C ISO/IEC 17021-1 clause 7.1.2 - Determination of competence criteria Document Control Systems, Procedures, Forms and Templates 2
G ISO 17023 2017-11 - Suggestions for good books ISO 17025 related Discussions 0
B Timeframe for updating QMS / transitioning from ISO 14971:2012 to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
B Gage calibration frequency, ISO and IATF - What are the requirements Calibration Frequency (Interval) 3
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 2
D Definition of equipment for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 1
L Biological Assessment (ISO 10993-1) Other Medical Device Related Standards 1
M ISO 13485:2016 Complaint Definition Clarity Customer Complaints 2
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
J ISO 9001:2015, ISO 14001 & OHSAS18000 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
S Qualification question - ISO 13485 Reliability Analysis - Predictions, Testing and Standards 0
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 11
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
G National Structural Steel Specification 7th Edition - Do I now have to be audited against ISO 3843-3 as well as ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
L How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 8536-4 Contamination Index ISO 13485:2016 - Medical Device Quality Management Systems 0
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
J Recommendations for online ISO 19011 training? Training - Internal, External, Online and Distance Learning 6

Similar threads

Top Bottom