Uncertainty calculation or uncertainty results are a requirement of ISO in two different applications or requirements. The first requirement is the Traceability under clause 6.
Traceability is applicable to our Master standards. One way to determine traceability is to have uncertainty results that is reflected on the calibration certificates of our master or reference standards. The second requirement is to Evaluate Measurement Uncertainty under clause 7. This is referring to the instruments of the customers that you will be calibrating. But you must understand that during the evaluation of measurement uncertainty, there are two types of contributors that we need to evaluate, the Type A and Type B.
Uncertainty from the reference standard reported in its calibration certificate is a Type B contributor and this is the main contributor that is required to be included in the uncertainty budget.
And as we can see, uncertainty results are required at both ends, uncertainty results that are reflected on the calibration certificate of your reference standards calculation performed by the higher lab , and uncertainty results reflected in the calibration certificate that you will issue to your customers calculation performed by your lab.
For the list of documents under Personnel Procedure, are those mandatory requirements to follow? If yes, would you have any reference samples to follow? We are currently the sole provider for calibration service and do not have any suppliers. Basing it on the requirements of ISO under clause 6. Except for training related activities as per clause 6. A simple letter or excel worksheet is ok. I will try if I can link a sample reference. Answer for question 2 Having the form alone without using it is not sufficient to show evidence.
You should send it to them to be accomplished or interview your supplier using that form. It is not a must, because there is another way to evaluate a supplier like performing an audit to them personally on their site using a defined checklist.
The purpose of evaluating a supplier is to determine if they can meet your requirements and the requirements of the standards in support of your calibration activities. Any outside services that you procure to support your operation are considered a supplier. These includes: 1. The third party lab 2. A national lab or a higher lab where you send your master standard for calibration 3.
If you hired temporary personnel to perform calibration on your behalf. I have some question regarding the calibration. We are using our own software to do calibration where the software generates calibration result and later on calculate uncertainty using excel. What and where are the things that need to be mention in the manual? Do we need to mention validity and traceability of excel?
Also, if one of our software is not yet accredited by any standard bodies, is there any way to get it validated? It should be monitored, calibrated, verified and validated to meet your specified requirements before putting it into service as per clause 6. As per my implementation, there is no need to mention in the manual, I just need to include it in the list where I can monitor it, for example in the calibration program. And, of course, it has a documented calibration procedure.
During an audit, you only need to show the evidence that it was validated before use. Validation requires calibration and verification Check my other post here about validation. You need to show that it meets specified requirements. In my knowledge, the software does not need any accreditations, only validation. What can be accredited is the competency that you can perform the calibration using, for example, the Measurescope as your standard with the indicated range and CMC.
If the excel you are referring is a form of a document, after performing validation, then it only needs to be controlled. One way to validate your excel, software or the whole method itself which includes traceability is to compare it to other software or related procedure available to other accredited labs. Look for a provider of these programs.
Would you advise for machines such as profile projectors and microscope that took reference from JIS standard JIS, JIS , what are the items that is mandatory to be addressed? Inside the documents there was a table that list down all the performance, im not too sure what are the items that need to be reference to document. Would there be any clause or guidelines?
First of all, ISO does not require any methods, a format, or content of a calibration method to be used for a specific calibration parameter. It can be necessary to provide additional documentation for optional steps in the method or additional details.
In other words, you can use it directly. There are Three Classifications of Methods or Two : 1. Standard Methods , from International, regional or national standards or other recognized specifications. Which is the one you just mentioned.
Non-Standard methods , like: a. Laboratory-developed methods 3. Standard methods used outside their intended scope or otherwise modified. If you will modify the procedure, just ensure it is aligned with your requirements or the requirements of your customer.
I will include the document JIS Standard as my reference and perform validation afterward. Method selection is based on: 1. The available method in your country regional or national 2. The International standards if no regional or national is available 3. Required by your accreditation body. Special Request of a customer 5. The study based on the capability of the Standard Instrument reference standard — non-standard method.
The things that need to be addressed with regards to the method used are the following: 1. If you modified the standard method. You need to perform validation as per clause 7. If you created a non-standard method, you need to perform validation as per clause 7.
Ensure that the method that you choose is the updated version as per clause 7. You can use the old version if this is required or specified by customer as per clause 7. And all other requirements that are stated under ISO clause 7. Clause 7. I have answered your concern in a more general view to include all methods or procedures, I hope it helps. Dear Edwin, I am working at testing and calibration laboratories past 2.
Please explain me. H Vinod, I feel your frustrations. Any specific concerns or clauses from the standard you need some clarifications, just comment it here and I will try my best to answer or interpret it for you.
Thank you so much, i found this quite helpful. I have a question though, are there any specific requirements for the physical layout of the lab?
I am in process of setting up a lab at home and was wondering if there are any specifications as to the physical layout of it.
Regarding your questions, there are no specific requirements for the physical layout of a lab that I am aware of. But there are requirements that we need to follow when choosing a lab, but are focus or concerned in the effect on the validity of results. For example, if your designing a lab that serve mass calibration, ensure that it is located on the ground floor to minimize the effect of vibration during calibration.
There are requirements that a lab must have as per ISO , under clause 6. Some requirements to consider that are related to the physical design of a lab are: 1. A room with a stable and clean environment. There is enough space for proper separation or segregation in order to: a. Some instruments or reference standards need to have a separate space because they are sensitive to temperature or humidity or other environmental factors.
This can contribute to error in results and therefore needs to be separated. Example, temperature instruments cannot be mixed with the dimensional instruments. Me again, thank you for the response and advise, i think i left a thank you comment in the wrong section :. I have another question for you, if I may. Where could I find various methods to which I can work my procedures from for my lab?
Is there a specific website I can visit for this? I am in mass digital weighing scales and in thermometry cold rooms and theremometers.
I would really appreciate your help. Regarding your concern about the methods or procedures that you need, below are my suggestions: 1. Check the national lab in your area and check their websites for existing methods that they use or recommend. If you are applying for accreditations, check also the requirements of the accreditation body.
Usually, they have specific requirements about this matter. And lastly, about weighing scales and temperature, there are many reference guides out there. Some are free and some need to be purchased. Below are some of the specific guides that you can start with I Have inserted the links. Euramet guides like Euramet cg and Euramet cg for temperatures b.
Euramet cg for weighing scales c. Regarding uncertainty calculation, is there a guideline to determine what are the compulsory sources of uncertainty? We are accrediting on field calibration and our product is in the category of optical CMM and will be using grid plate and step gauge to calibrate XYZ. We are accrediting through ANAB and the reference guideline is mostly on expressing the uncertainty factors. Would you advise how should i progress? Nice to see your comments again. I understand what you feel but just push through and you can do this.
Yes, there are many guidelines that are given based on the calibration procedure that you follow if there is available but you need the patience to search for them. But what if there are no guidelines available? This is where the process of method validation takes place. It involves your knowledge, skills, and familiarity with the procedure you are implementing.
The good news is, In measurement uncertainty calculation, you do not need a complete list to come up with perfect significant factors to include in the uncertainty budget.
It is based on your knowledge and experience, which is why it is important that the person who will conduct the method validation and calculation of uncertainty should be knowledgeable and experienced. During your assessment and evaluation stage, you can use different guidelines as a reference with related characteristics with your measurement process.
Below are some of my suggestions:. As per the compulsory contributors, the following lists are what I observe and based on my past experience in calibrating a CMM:. Resolution of the standard and UUC b. Repeatability c. Reproducibility d. Uncertainty of STD from its calibration certificate e. Drift of the standards.
Check for related measurement process with other guides, for example, the gauge block calibration guide, some properties of the gauge blocks are applicable to the step gauge if the step gauge has the same material with the gauge block. Examples of these contributors are: the coefficient of thermal expansion, effects of temperature difference, the accuracy or MPE, effects of difference in coefficient of thermal expansion and other related contributors.
Look for related guides and articles about the reference standards you are using to give you a reference for its characteristics. You may also contact the producer of your reference standard for any related procedure or guides that they can provide. Another is to contact your national lab, there is also a possibility that they have the methods.
In my country, the national lab is also providing specific training. Once you have completed your uncertainty calculation, try to participate in an Interlab-Comparison ILC activity, or much better, Proficiency Test PT to see if your uncertainty results are within the acceptable range.
This is also a good part of method validation. You are welcome. Happy to help. I am glad to know that you have now a better perspective. I hope that you can complete now your accreditation process. I want to know that single person can become owner, quality cum technical manager in iso …. As per my experience, it is not possible because you will be facing a non-conformances with regards to Risk to Impartiality.
Or is the system enough? Is that mentioned in his standard? Or are there any other guidelines regarding this? My answer to your question is YES, it is enough and no need for other monitoring if you can meet or ensure the below criteria: 1. Can you extract the previous data for review or if requested?
Is the data can be recorded and stored for a defined period of time? It is not directly stated to use a thermometer or hygrometer but some auditors are requiring a continues recorder of temperature and humidity that is directly seen or observed inside the lab. As long as you can demonstrate that the SCADA meets the above criteria and can perform below requirements, then I believe it is ok. But as per my observation and experience, the location of the SCADA temperature and humidity display is in a remote area of the facility, and therefore, it is hard to obtain the real-time value of the temperature and humidity during recording and actual performance of measurements.
If this is not the case for you then it is not a problem. My suggestion as part of quality control, you may implement to have a separate thermo-hygrometer, it can be a handheld type, wherein you schedule a period to check the temperature and humidity of a specific room that is critical in your process in addition to the SCADA monitoring.
During the analysis, YES, it is important to include the temperature and humidity in your record. See number 2 below for more details. The monitoring of environmental conditions is a requirement under ISO Below are the clauses: 1. Clause 6. It should be properly documented.
You need to specify the acceptable environmental conditions of the lab then ensure that the environmental conditions should be within these specifications. Calibration certificate shall include b the conditions e. NOTE This can be performed by external personnel. If you encounter complaints, there should be a person either an employee of the company or external personnel that will handle the complaints. He will be the one who will perform the investigation. This person is not in any way related to or connected in the complaint.
The complaints cannot be designated or cannot be handled by the person who has involvement in the complaints. Hi Ramesh, Risk assessment records are the recorded identified risks, either for risk to impartiality or risk related to laboratory activities. Please note that this is just an example. You can design your assessment records based on your understanding and your needs. Dear Edwin Our material testing lab is in the preparation stage for accreditation.
Actually we are confused regarding calibration. For example. For example,for softening point test ,there are steel balls of specified weights and diameter. It is really confusing if you are handling an instrument with many parameters associated with it. I encountered that a lot, but luckily, I have determined how to access if it needs calibration or not by using the below guidelines.
I am not familiar with your instrument and procedure but in order to identify if it needs calibration or not, below are some of my suggestions. Determine its criticality as per usage. Does it have an effect on the validity when testing your sample? For example, the steel balls, if it has a direct effect that contributes to the results to be tested, then it needs calibration.
Is there a requirement from the procedure that requires a specific size or weight before use? If none, no need to calibrate. You may also perform a simple verification, there is no need for an accredited lab for this. For example, the steel balls, if there is a requirement of size or weight, you just need to purchase a caliper or a weighing scale wherein every time you use the steel ball, just measure its mass or diameter.
Just keep its record. Be sure that the caliper or balance is calibrated. I have a post on how to determine instruments if it needs calibration or not. I suggest you read it.. To my understanding, intermediate check is as same as QC procedure where we need to ensure our measuring equipment are working properly in between calibration interval by any means of QC test. Please note that the corrected versions for this standard apply only to the French and Spanish language.
The English version of the standard is not concerned. Life cycle Previously Withdrawn. Final text received or FDIS registered for formal approval. Proof sent to secretariat or FDIS ballot initiated: 8 weeks. Close of voting. Proof returned by secretariat. International Standard under systematic review. This may also interest you. Medical laboratory testing How can we trust the results? But what about products? How do bananas from Costa Rica get through customs in France?
Or watches ….
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