Regulatory requirements »
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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ISO 13485 Standard:2016 – 4.2.5 Control of records
Directly related to document control, I will now discuss record control requirements. The ISO 13485 Standard requires a definition of what records are included in the quality management system and how they are controlled.
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ISO 13485 Standard:2016 – 4.2.4 Control of documents
The documents and information of the QMS must be controlled. This is a key element of a QMS. The main idea is to provide control over the documents necessary for the operation of the
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