The standard is also useful to universities, research centres, governments, regulators, inspection bodies, product certification organizations and other conformity assessment bodies with the need to do testing, sampling or calibration. The new version covers technical changes, vocabulary and developments in IT techniques. It also takes into consideration the latest version of ISO In an increasingly globalized world, trade and traceability is getting trickier as supply chains get longer and more complex.
Wednesday — January 26, Suggested reading. What does ISO require for laboratory measurement equipment and related procedures? Igor Stameski July 25, How can ISO help improve laboratory measurements?
Present industry research and development Testing is used in many industries, but offering testing as a professional service If your organization is seeking to adopt ISO in your laboratory environment, the You have successfully subscribed! 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. The standard has provided the competence requirements and the need to have a competent personnel, but does not explain or provide detailed information on the specific requirements for personnel competency, how to implement or what are the specific requirements for a personnel to be competent.
The reason is that competency requirements for personnel are based on the scope or capability of the laboratory and it differs for every lab. The important thing is that we should provide all the necessary competency documents as evidence to support the requirements of the standard. Competency is demonstrated by performing a specific lab activities effectively as per Job description.
And since it shows competency whenever it is performed as expected, it can now be used as a performance criteria to show that a personnel is competent. See below examples:. You only need to prove that they are competent. As an advice, just show only what is asked by the auditor.
Evidence of competency is simply the records of training supported by certificates, diploma and resume where records of qualifications like education, training, technical knowledge, skills and experience can be seen. See more evidence example at the bottom of this post. In order to show the implementation and documentation of personnel competency, I will share with you a simple procedure that works with me that you can copy or provide a guide for your own implementation.
See below the step by step implementation of Competence Requirements. The initial step to determine competency of personnel is to identify the competency that you require to do the laboratory activities within the lab. This will serve as the basis in finding the right candidate for the job.
Below are the Initial Competence Requirements for Personnel that we need to identify and consider:. Once we have identified the Job descriptions and competency requirements that we need for a laboratory personnel, it is now time for a recruitment and selecting the best candidate to be hired. Once done, it is now time to implement the training program.
Training and competency are linked to each other. Training is needed whether a personnel is already competent or not. It is a must activity in order to attain the required skills, knowledge and capability, thus, becoming competent. There are 2 reasons why we need to have a competent person training program. The second reason is for introduction purposes.
At this stage, we already hired the best personnel that we need. Maybe you are thinking, why is there a training if you already hired a competent personnel in the initial stage? There are learning and development stage as part of the training program. Scheduled internal and external training are provided which are monitored and supervised.
A training program involves a training plan, training attendance, and training evaluation and finally the authorization. One part of the training is the performance evaluation, a process for verification of personnel competency.
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