ISO 13485:2016 Standard Section 4 – Quality management system »
Review of sction 4 – Quality management system of the ISO 13485:2016 Standard for Quality management systems — Requirements for regulatory purposes
ISO 13485 Software – What do I need to know?
ISO 13485 Software – which ISO 13485 Requirements can it maintain? ISO 13485 Software – Management of documents Management of documents related to the QMS like drawings or work instructions, including version management and
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Practical FAQ about ISO 13485
What is the ISO 13485 Standard? The ISO 13485 Standard is an International Standard which specifies requirements for a quality management system to be be used by an organization involved in designing and/or producing
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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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Software Validation ISO 13485 – Validation of Software applications
Software validation ISO 13485 is a critical tool used to ensure that the realization processes operated by software-automated operations are performing as expected. Software validation is accomplished through a series of activities and tasks
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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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