ISO 9001:2015 Certification
We are proud to announce we are now certified to ISO9001:2015. This new standard is replacing the 2008 revision that we have been following for the last two years. Following our 2016 external audit we set ourselves the challenge of transitioning to the new standard ready for this year’s audit which was completed in February with no corrective actions required. The deadline for transition is September 2018, but we decided the new ideas introduced in this standard would be beneficial both to our internal processes and the work we do for our customers, so an early transition was a no-brainer.
As part of our software development procedure we have two possible routes dependent on the type of project:
Low Risk Software Development
The low risk process covers general projects and allows us to record the development stages, the testing that has been undertaken, any meetings to discuss the project either internally or with the customer and accurate version tracking. This is all stored in an Excel spreadsheet that can be supplied along with the completed project or at any point during development.
High Risk Software Development
The high risk process allows for a greater level of documentation and follows the software lifecycle from BS:EN62304. It is particularly suitable for medical device software as it includes classifying the software based on potential risk to users and specifies the documentation required for each class. The Excel development log is still used for an overview of the development, however alongside this detailed software specification documents including data definitions, wireframes, functional requirements and fully documented testing can be provided.
Contact us to discuss how we can help you with your ideas