ISO 13485:2016 Medical Device -QMS|Clause 8.1 Measurement , analysis and improvement |L-13

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ISO 13485:2016 Medical Device -QMS|Clause 8.1 Measurement , analysis and improvement |L-13@ivdmanufacturing7208

If you refer back to the Plan-Do-Study-Act Deming Cycle shared towards the beginning of this guide, measurement is part of the ‘Do’ stage, analysis is part of the ‘Study’ stage, and improvement is part of the ‘Act’ stage.

During product realization, you defined product specifications. And throughout product realization, it is crucial to measure against specifications, analyze if there are trends, and make improvements. The same methodology also applies to the QMS as a whole.


The organization is required to not only monitor and measure their products, but also to determine the appropriate equipment that they need to adequately and accurately monitor and measure. As an organization you need to make sure that the equipment is maintained and calibrated correctly.

Throughout product realization, you are likely to use a variety of equipment to measure and monitor various aspects of your medical device. Any such equipment must be calibrated or verified to proven standards and criteria so that you know with confidence that the monitoring and measuring data is accurate and precise according to ISO 13485.

Such equipment shall also be labeled with identification, calibration status, and due date. You should maintain a record of all monitoring and measuring equipment, including calibration details. A good standard to consider for monitoring and measuring equipment is ISO 10012.
Planning of Product Realization
Customer-Related Processes
Design and Development
Purchasing
Production and Service Provision
Control of Monitoring and Measuring Equipment
Design and development processes include:
Design and Development Planning
Design and Development Inputs
Design and Development Outputs
Design and Development Reviews
Design and Development Verification
Design and Development Validation
Design and Development Transfer
Control of Design and Development Changes
Design and Development Files

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