ISO 13485:2016 Standard Section 8 – Measurement, analysis and improvement »
Review of sction 8 –Measurement, analysis and improvementof the ISO 13485:2016 Standard for Quality management systems — Requirements for regulatory purposes
ISO 13485 Standard:2016 – 8.3.4 Rework
Rework in the eyes of the ISO 13485 Standard is considered the performing of an action on a nonconforming product or service needed to eliminate a detected nonconformity and to make the Medical device
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ISO 13485 Standard:2016 – 8.5.2 Corrective Action
Corrective action is one of the foundation elements of quality management and is essential for sustaining improvement of the QMS. The main concept of corrective action promotes a systematic analysis of quality problems that
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ISO 13485:2016 Standard – 8.2.1 Feedback
The ISO 13485 standard requires the evaluation of feedback regarding the use of the medical device; the organization is to continually and systematically evaluate whether the medical device meets the requirements throughout its life-cycle:
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