Test development activities follow documented procedures. Processes have been refined from experiences to meet relevant standards such as ISO9001-2000, ISO/TS-16949 standards.
http://nmca-nm.org/about/ Development is focused on test requirement analysis and documentation in the form of a test specification . Design verification activities include reviews at key points during the design. Reviews include organized peer reviews of the product-related hardware, fixtures, and software. A risk analysis of test requirements and test designs is performed for test solutions for medical devices and for other high risk products as required. Test reviews and other key activities are called out in a project plan. Projects are not complete without a validation process. A test plan is written, approved, and implemented to fulfill the validation phase.
- Gather initial information and test intent
- Propose a test solution with preliminary requirements
- Solidify test requirements
- Develop / document test solution
- Validate test solution
- Deliver test solution to production environment
- Request for quote
- Test Specification
- Design Specification
- Test plan / test results
- Transition / maintenance