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 the workflow for releasing a document. This feature must include also permission management – who is allowed to do what with the document and the distribution.
The risk – choosing and implementing an ISO 13485 Software that does not answer the standard requirements
To Do:
- Under Stand the ISO 13485 Standard requirements for document Management
- Prepare a check list
- Make sure that the software does answer all the requirements
ISO 13485 Software – Regulatory Requirements
As part of providing evidences for the safety of the medical device, the organization will be required to maintain certain type of documentations required by local authorities – know to us as the regulatory requirements. Now, this may be tricky. If you are marketing in several regulatory environments (for example, USA is one regulatory environment whereas the EU is another), the ISO 13485 Software must be able to comply to both regulatory requirements.
The risk – choosing and implementing an ISO 13485 Software that does not answer the regulatory requirements
To Do:
- Under which are the relevant regulatory requirements for document Management
- Prepare a check list
- Make sure that the software does answer all the requirements
ISO 13485 Software – Managing Training
ISO 13485 Software may be used to manage trainings. In this case the Software should be able to at least:
- Define roles on the QMS and assign required qualifications, skills and knowledge
- Maintain records of qualifications of all quality management system related personal
- Maintain training records
- Be able to manage a training plan including some notifications and alerts
- Produce evidences of training like internal certificate or reports
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