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The instrument to be used should be suitable.
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With this in mind, all the instruments that are used for monitoring and measurement should be controlled.
THEME HOSPITAL ISO VERIFICATION
“It is either we perform a measurement to monitor and control a process or we perform measurement for verification of the output of our process.” Instruments that we use to perform measurements are considered monitoring and measuring instruments. This depends on the criticality and the effect it can contribute to the calibration performed.īut mostly, the two environmental conditions that are always controlled are temperature and humidity because almost all instruments require it for proper functioning, it is detailed in their specifications.Ĭlause 7.1.5. Not all listed above needs to be controlled simultaneously inside a lab. Some examples of environmental conditions that we need to monitor and control are:
THEME HOSPITAL ISO ISO
Same with ISO 17025 requirements, environmental conditions that influence the final output of calibration results should be monitored and controlled. This clause requires the monitoring and control of the environment for the correct performance of calibration. These are the calibration requirements as per my experience, you may include other clauses you know that are directly affecting the calibration results.Ĭlause 7.1.4 Environment for the operation of processes Clause 9.1.1 General requirements for monitoring, measurement, analysis, and evaluation Clause 7.1.5.2 Measurement traceabilityĦ. Clause 7.1.5.1 General monitoring and measuring requirementsĤ. Clause 7.1.4 Environment for the operation of processesģ. These clauses that I listed here are the clauses with calibration requirements that are directly affecting the calibration results, these are:Ģ. What are the Calibration requirements of ISO 9001? Below are the related clauses where calibration requirements are provided. ISO 9001 Calibration procedure – The content of a calibration procedure The related clauses of ISO 9001 that are focused mainly on calibration requirements.Ģ. This calibration management is guided by ISO 9001: 2015 Standards which has dedicated clauses that detail the requirements needed for proper implementation.ġ. What is calibration and why do we need calibration? Visit my other post in this link > calibration awareness There are other more specific standards for specialized industries like automotive, pharmaceuticals or Oil and Gas but ISO 9001 is still integrated with them.įor a calibration process to be properly implemented, there should be in-house calibration management that we should follow. ISO 9001 is the quality management system designed for manufacturers (producers of products) or service providers. In short, quality is maintained when calibration is performed. Almost all industries used monitoring and measuring equipment to manufacture products or support services, it is required that this equipment must be calibrated in order to ensure that the intended product specification is achieved.