Quality management system »
FDA QSR 21CFR 820 Transition to ISO 13485:2016 – FAQ
The FDA has come up with the initiative to harmonize FDA QSR 21CFR 820 with the ISO 13485:2016 – Medical devices — Quality management systems — Requirements for regulatory purposes. The goal is to
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ISO 13485 – 5.4.1 – Quality objectives
Quality objectives have a strategic role of carrying out the quality policy and its implementation through a quality management system and provide a means to assess whether the QMS achieves its goals. The effectiveness
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