Certification Preparation Support
In many industrial areas of application, complex systems with software and electronic hardware are increasingly used for recording, management, display and monitoring purposes. Each sector has its own standards and legal requirements with regard to product and process quality assurance and safety.
- Avionics: DO-178B / DO-178C, DO-254, ABD100, ARP4754 / ABD200: specific EASA/FAA guidelines and authorisation aspects for software/electronics (CRIs, CAST)
- Automotive: IEC 61508, ISO 26262
- Medical technology: EN 62304, IEC 80001
- Pharmaceutical: FDA, GxP, FDA 21 CFR Part 11, Parts 210, 211, CPMP/ICH/135/95
- Rail: IEC 61508, CENELEC EN 50126 / EN 50128 / EN 50129
- Other: CMMI, ITIL, ISO 15504 SPICE (with sector-specific nuances)
SQS provides specialists who support you from the planning phase through to the certification or sector-specific product approval of your systems.
We help you master your tasks through a structured approach, which has proven its success through many projects. By analysing the existing processes, we show you which improvement measures are required and expedient for your project and how they can be suitably implemented. Our portfolio is rounded off by special courses and workshops.
SQS offers the following preparatory certification services:
- Gap analyses with regard to processes; documentation on the basis of ISO-15504 (SPICE) or CMMI methods
- Qualification of electronic systems
- Documentation and process support
- Courses and workshops (1-day management courses, 2-day training courses and 3-day workshops)
The customer’s benefits at a glance:
- Effective and efficient preparation for achieving product/process/quality approval in a regulated environment
- Suitable processes that demonstrably fulfil the targets and requirements of the approval body
- Early coordination with the authorisation/approval bodies
- Successful qualification and approval process
Innovations in Teamcenter testing
Siemens PLM
SQS specialises
in testing and quality
management of
Siemens PLM
products such as
Teamcenter.