Is there any forum to ask for ISO 17025 interpretation?
is there any forum to ask for ISO 17025 interpretation or the way to understanding this standard?
Sorry for my bad english!!!!!!!!!!!!!
Paito
It is related to testing and calibration I believe. We have a calibration forum, but not a specific one for ISO 17025.
I will move this post over there and please ask your question below.
Regards,
Simon
My english not good too
ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.It is applicable to all organizations performing tests and/or calibrations.
1. What is ISO 17025? ==>
2. you can serach from UKAS Guidance on the Application of ISO/IEC 17025 Dealing with Expressions of
Opinions and Interpretations (© United Kingdom Accreditation Service 2001).
3. For consider ISO 17025: 2005 ACCREDITATION- http://17025.homestead.com/
4. Preparing for Accreditation - http://www.a2la.org/appsweb/applytestlab.cfm
5. ISO/IEC 17025 in Laboratories - http://www.labcompliance.com/tutorial/iso17025/default.aspx
Hope these could help you.
Naamfon
Thank you very much!. If you know a forum to discuss about this standard please let me know!
Paito
Dear Paito ,
My english not good too.We can understand right ?
ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.It is applicable to all organizations performing tests and/or calibrations.
1. What is ISO 17025? ==>http://www.youtube.c...feature=related
2. you can serach from UKAS Guidance on the Application of ISO/IEC 17025 Dealing with Expressions of
Opinions and Interpretations (© United Kingdom Accreditation Service 2001).
3. For consider ISO 17025: 2005 ACCREDITATION- http://17025.homestead.com/
4. Preparing for Accreditation - http://www.a2la.org/appsweb/applytestlab.cfm
5. ISO/IEC 17025 in Laboratories - http://www.labcompliance.com/tutorial/iso17025/default.aspx
Hope these could help you.
Naamfon
Would you can give some details about your concern on ISO 17025 Standard, i.e what is the specific parts of the standard you want to discuss (Technical or managements requirements, procedures, manual ... etc, so we can begin that here on our wonderful IFSQN forums. I would appreciate the kind support of Naamfon on this field.
Youssef
I would like that in your high level forum about food safety can be open a topic about ISO 17025 standard. The target is that any person could ask about interpretation, implementation, problems, refer to standard. For example: ¿can anybody tell me the significance of no conforming work, clause 4.9? or when i must use the accreditation simbol in a report? etc.
I speak spanish, so sorry for my bad english but I hope that you can understand me!
Paito
Dear Piato
Would you can give some details about your concern on ISO 17025 Standard, i.e what is the specific parts of the standard you want to discuss (Technical or managements requirements, procedures, manual ... etc, so we can begin that here on our wonderful IFSQN forums. I would appreciate the kind support of Naamfon on this field.
Youssef
For example: ¿can anybody tell me the significance of no conforming work, clause 4.9? or when i must use the accreditation simbol in a report? etc.
Control of nonconforming testing and/or calibration work of ISO 17025
Clause 4.9
4.9.1 The laboratory shall have a policy and procedures that shall be implemented when any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements of the customer. The policy and procedures shall ensure that:
a) the responsibilities and authorities for the management of nonconforming work are designated and actions (including halting of work and withholding of test reports and calibration certificates, as necessary) are defined and taken when nonconforming work is identified;
b) an evaluation of the significance of the nonconforming work is made;
c) correction is taken immediately, together with any decision about the acceptability of the nonconforming work;
d) where necessary, the customer is notified and work is recalled;
e) the responsibility for authorizing the resumption of work is defined.
4.9.2 Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of the laboratory’s operations with its own policies and procedures, the corrective action procedures given in 4.11 shall be promptly
This clause is significant beacuse If the test or calibration is completed correctly and the item does not pass, then it is NOT non-conforming work, it is a failure of the unit under test.
when any aspect of its testing and/or calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements of the customer it's mean if the lab discovers the non-conforming work after the work is complete, and before it reaches the customer. If you experience this then employ the corrective action protocols.
accreditated organizations/laboratories may use the local accreditation logo after being accreditated to ISO 17025 and the logo can be used on certificates and reports, business cards, letterheads, etc., .The calibrations or tests reported in this manner must be performed under the terms of their accreditation and must be included on the laboratory’s Scope of Accreditation.
Ho!
Nice explanation of "non-conforming work", (I think
My guess is that some of the confusion is in the potential use of "work" / "non-conforming" in 2 ways - (a) as referring to internal, self-directed, activities for the lab's own self-control and (b)as referring to results for projects / measurements etc carried out specifically for the customer's request.
Rgds / Charles.C
I would present this situation:
We have one microbiological test accredited by one accreditation organism in my country. This test says 2 days for incubation samples.
The customer is according with made the incubation for 72 hours ( because of there is a weak end), (this time not modified the final result ) so my questions is:
a) is this a non conforming work ?
b) In the report I write a legend for no conforming work and the report have the logo of accreditation organism? or
c) the report wil be without legend and without logo?
I have a lot of auditories and the auditors no are in accord sometimes .One person say OK an other say no!!!!!! it is no noconforming work and without logo!!!
I hope that you can understand me!!!!
Thank you for your opinion!!!!!
Dear Naamfon,
Nice explanation of "non-conforming work", (I think, definitely not my area of expertise). i can understand why the ISO-speak text is not too easy to follow.
My guess is that some of the confusion is in the potential use of "work" / "non-conforming" in 2 ways - (a) as referring to internal, self-directed, activities for the lab's own self-control and (b)as referring to results for projects / measurements etc carried out specifically for the customer's request.
Rgds / Charles.C
Hi!
I would present this situation:
We have one microbiological test accredited by one accreditation organism in my country. This test says 2 days for incubation samples.
The customer is according with made the incubation for 72 hours ( because of there is a weak end), (this time not modified the final result ) so my questions is:
a) is this a non conforming work ?
b) In the report I write a legend for no conforming work and the report have the logo of accreditation organism? or
c) the report wil be without legend and without logo?
I have a lot of auditories and the auditors no are in accord sometimes .One person say OK an other say no!!!!!! it is no noconforming work and without logo!!!
I hope that you can understand me!!!!
Thank you for your opinion!!!!!
Dear Piato
You say this situation of expanding the time of incubation "for a day" not affect or modify the test result:
The judgement depends on the type of the performed test; what is the final result of incubation? is it a countable test or isolation of a microorganism?. This condition is only accepted if the result of the test is negative for isolation "no growth of any microorganisms", So, you can passed the test this time. Meanwhile if the test other than this exception the test result should be rejected.
Regards.
Youssef
Hi!
I would present this situation:
We have one microbiological test accredited by one accreditation organism in my country. This test says 2 days for incubation samples.
The customer is according with made the incubation for 72 hours ( because of there is a weak end), (this time not modified the final result ) so my questions is:
a) is this a non conforming work ?
b) In the report I write a legend for no conforming work and the report have the logo of accreditation organism? or
c) the report wil be without legend and without logo?
I have a lot of auditories and the auditors no are in accord sometimes .One person say OK an other say no!!!!!! it is no noconforming work and without logo!!!
I hope that you can understand me!!!!
Thank you for your opinion!!!!!
Dear Paito..
First you have to take alook on your MIcro Method, i mean you have to see what temperature that you use for micro incubation. As I know if you follow BAM the incubation of MIcro (mesophilic) is 35±1 oC for 48 ± 2 Hours and if you follow ISO STd the incubation is 30 ± 1 oC for 72 ± 2 Hour..
So depends on standard method that you choose it. if you say your follow ISO Standard, then you work you use BAM (for incubation time only), you have non conforming work.
Hope can make you clear
rgds
AS Nur
Hi!
I would present this situation:
We have one microbiological test accredited by one accreditation organism in my country. This test says 2 days for incubation samples.
The customer is according with made the incubation for 72 hours ( because of there is a weak end), (this time not modified the final result ) so my questions is:
a) is this a non conforming work ?
b) In the report I write a legend for no conforming work and the report have the logo of accreditation organism? or
c) the report wil be without legend and without logo?
I have a lot of auditories and the auditors no are in accord sometimes .One person say OK an other say no!!!!!! it is no noconforming work and without logo!!!
I hope that you can understand me!!!!
Thank you for your opinion!!!!!
Hello.
I am assuming you are working in a testing laboratory, rather than calibration... (I also think a forum for ISO 17025 would be good)
If, for example, the microbiology test was aerobic colony count and you were incubating for 2 days, rather than 3 days as stated in the ISO method, it would be classed as a 'deviation' from the standard, rather than a non-conformance.
This should be acceptable to do, as long as you add a 'deviation' section onto your method to state that incubation is for 48 hrs rather than 72 hrs and have validation to prove that method is still fit for purpose using this incubation time.
So your questions:
a) No, as above. It should be a deviation rather than a non-conformance.
b & c) No legend should be required to say that it is non-conforming. However, you could add a legend to state that test incubation is for 48hrs on test report. If the test is accredited, (and deviation accepted by accreditation body) you may use the symbol of the accreditation body.
Hope this helps
Pops