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Hello, I am wondering if a medical company can calibrate their own measurement equipment? They would use this calibrated equipment to measure specific parameter of the instruments they sell.
We are initiating to get accreditation for ISO 17025:2017 for our laboratory, we are pharmaceutical company having all the related SOP's for ISO 9001:2015, etc.
All the required SOP's related to laboratory working including testing procedure, calibration/qualification of equipment, validation of methods/qualification of personnel working in lab for their competency.etc. what you suggest we can get it done easily.
Secondly, is it required to get accreditation for each testing method perform in the lab? or just need to prove that we are working as a competent lab as all the tests performed under the required environment using qualified equipment by competent personnel.
I have some asking for my clear understanding on Root cause analysis as well as CAR form.
What is the process?
What are the procedures?
What is the technical errors?
What is non-technical errors?
Which subjects will be considered as a training problem.
What is the difference between process and procedures?
What is immediate action?
What is corrective action?
Do you have any best guidelines that will help me to be an expert on CAR- PAR.
What are the differences in Risk Analysis of ISO 9001 & ISO/IEC 17025?
What are the steps to be taken to declare an Organisation involved in calibration and testing for Self Declaration to the ISO/IEC 17025 standard?
Hello, I am wondering if that is necessary for me to have the ISO 9001 to be able to get ISO 17025?
Why the structure of ISO 17025:2017 isn't consistent with HLS as ISO 9001:2015?
Handling of calibrator equipment/reference materials. We have audit finding from our external auditor, is looking some procedure of handling and storing reference materials such as lubricant, electrical cables and other accessories of the multi-product calibrator.
I want to know more about ISO 17025 Auditing to help me in auditing.
How to address risk and opportunities in the laboratories and examples in the area of calibration laboratories?