Misunderstanding quality issues in calibration can put your operation and goals in serious danger. Firstly, it states the purpose of monitoring and measuring, namely, “to provide evidence of … a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international standards or national measurement standards…” Clause 7.6 of ISO 9001:2008 QMS Standard deals with control of monitoring and measuring equipment. 5. the clause under ISO 17025:2017 and ISO 9001:2015 related to technical records I also discuss the lists of calibration documents which include the form that we need to have in order to maintain compliance with the requirements of ISO 17025 Standards including ISO 9001:2015 calibration … For example, users would say calibration requirements that were in ISO 9001:2009, clause 7.6 Control of Monitoring and Measuring Equipment are now clause 7.1.5, Monitoring and Measuring Resources. The aim is to establish a systematic approach to considering risk, rather than treating “prevention” as a separate component of a quality management system. With these changes going on, there were a lot of alterations in the amount of clauses between the two, as well as which clauses are considered to be requirements. The purpose of requirements in clause 7.6 of ISO 9001:2008 QMS Standard is to ensure suitability of monitoring and measuring equipment. In section 7 (Product realization) of ISO 9001, clause 7.6 deals with “Control of monitoring and measuring equipment”. Q: ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements, clause 7.6a states, in part: “Where necessary to ensure valid results, measuring equipment shall. I heard many users say ISO 9001 changed the title and terminology from devices to equipment to now resources but it is still about calibration equipment. Date Printed: 12-Oct-17 Form Rev: Orig . The purpose of this process is to monitor, measuring and take appropriate corrective action from customer complaints and feedback. Section 4.4 of the standard, titled Quality Management System and its Processes covers … ISO 9001:2015 has relaxed the strict requirement for quality management documentation. Home » Resources » Understanding ISO 9001 calibration requirements Calibration requirements and all of the expectations surrounding them can be a struggle for companies. https://control.com/technical-articles/iso-9001-calibration-explained (Note: Clause numbers below are from ISO 9001:2008.) The older one was updated in the year 2008, while the most up to date came out in 2015. In a recent article, Monitoring and Measurement: The basis for evidence-based decisions, I discussed the importance of using good evidence-based decisions to improve the effectiveness and efficiency of your organization.I also mentioned that this evidence needs to be accurate and adequate. ISO 9001 requires calibration for gage blocks, micrometers, pin gages, calipers and thread gauges; according to Industrial Calibration Services (In-Cal), the standard also calls for calibration of a variety of digital measuring devices, including voltmeters, oscilloscopes and power supplies. This clause interalia speaks about calibration of monitoring and measuring equipment. In previous editions of ISO 9001, a clause on preventive action was separated from the whole. ISO 9001 Clause 7.6 is often quickly looked over without much thought, but what is it really all about? However, in order to satisfy the remaining documentation requirements and to properly implement the Quality Management System (QMS), ISO 9001 Processes, Procedures and Work Instructions are typically still employed. The two most recent versions of the ISO 9001 standard include ISO 9001:2008 and ISO 9001:2015. 7.6 is often quickly looked over without much thought, but what is it really about... 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