Monthly Archives: June 2018 »
ISO 13485:2016 Standard – 7.5.1 Control of production and service provision
The organization is required to perform the realization of the product and the provision of the service under controlled conditions. The control must be performed and achieved according to the planning requirements specified within
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ISO 13485:2016 Standard – 7.1 – Planning and documenting risk management activities
The organization is required to define, plan, establish, document, and maintain one or more processes for risk management activities that will cover the entire realization processes of the medical device and refer to all
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ISO 13485:2016 Standard – 6.4.2 Contamination control
Contaminated or potentially contaminated products may risk the work environment and thus may have an adverse effect on product quality, performance, and safety of other products. The ISO 13485 Standard requires establishing, documenting, and
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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 13485:2016 Standard – 6.3 Infrastructure
Infrastructures are the stock of the basic facilities and equipment needed for realizing the medical device or providing a related service. Infrastructures should provide the suitable conditions and accessories to perform the appropriate business
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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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