Quality System Development
A useful Quality System should consist of:
- Processes, defining activities, responsibilities and output work products
- Commented template providing structure and guidance on work products
- Good examples of documents, that can be used as models for the projects
- Guidelines that provide detailed “how-to” in needed areas
The processes and templates may be the formal elements expected by a standard but for the end-user templates, good examples and guidelines are often more useful in the daily work.
A process should contain the following elements:
- Objectives and review criteria for the process outputs
- Input and output work products
- Activities to create the process output
- Guidance as needed
Copying the standard is not useful. A process need to define the company approach, using company terminology and referring to the company document structure. A process typically also requires more detail than what the standard provides.
There are a number of factor that contribute to successful quality system development.
Adapt to company. As already mentioned the quality system need to be developed to company needs, using company terminology and methods and align to other process and guidelines in use. A quality system that does not meet these criteria tend to be unused or cause issues due to conflict with established approaches. Pushing these issues to the projects to resolve is ineffective and may lead to quality and safety issues.
Balanced. It is easy to become over-ambituous when establishing new processes. A balanced approach is most effective. When Novotis writes complete Quality Systems we ensure balance and consistency. If the company want to develop quality systems themselves they should be carefully reviewed to ensure that goals are met.
Written for the end-user. If a quality system is to be used it has to be written for the intended user, the project leader, developer or tester. That quality system has to be easily accessible, provide a clear overview and give easy access to what the project need.
A Quality System is no replacement for skilled staff. Training is needed in addition to processes, good examples and guidelines. Novotis recommends a mixture of training sessions and on-the-job-training.
Novotis do quality system development for ISO 26262 and SPICE covering system, software and hardware.
In Quality System Development we take responsibility for:
- Training material
We develop good examples in collaboration with pilot projects.
Contact us discuss your needs and obtain a proposal.