eMS Quality and Information Security Management Systems (QMS & ISMS)
A certified QM/ISM system demonstrates to customers and regulators that an organization is taking the necessary steps to ensure that the products it develops are safe and effective. The implementation of such a system should increase efficiency and reduce the risks of recalls and liability claims.
BAYOOSOFT Themis is your validated solution for documentation processes associated with quality and information security management systems. Digitize linked processes and sustainable reduce documentation efforts while minimizing redundant data.
BAYOOSOFT Themis assists you in the following processes for setting up, implementing, maintaining and continuously improving your management system:
Product Packages for Management Systems
Management Systems Pack
A management system is a structured framework that supports organizations in structuring, controlling and continuously improving their business processes. Central components are:
- Definition of roles and their responsibilities
- Defining rules and processes to achieve specific company goals
These systems ensure better efficiency, competitive advantages and compliance with legal regulations. The Management Systems Pack enables you to create, maintain and continuously improve these components in the form of an integrated management system. By combining it with the guides explained below, you can combine several standards at once to exploit synergies and simplify management.
ISO 27001 Guide
The ISO 27001 Guide covers all requirements of the ISO standard of the same name and thus specifies all requirements for the establishment, implementation, maintenance and continuous improvement of a documented information security management system (ISMS), taking into account the context of the organization.
The task-based approach ensures that your ISMS fulfills all requirements. In addition to these requirements, the guide contains the information security measures referenced in the annex, so that these can also be taken into account in your information security efforts.
ISO 13485 Guide
The ISO 13485 Guide guides you through the requirements of the ISO standard of the same name in a convenient and task-based manner. It specifies all the requirements for a comprehensive quality management system (QMS) for the design and manufacture of Medical Devices.
ISO 9001 Guide
ISO 9001 specifies minimum requirements for a quality management system (QMS). These must be taken into account in internal processes in order to meet customer requirements and other requirements for your product and service quality. By using the ISO 9001 Guide, you ensure that you have taken all requirements into account.
Would you like to include other standards in your integrated management system? Take a look at our roadmap - we may already be working on it. Or give us feedback on which standards are missing for your organization via this roadmap.