Quality & EHS software for the Automotive industry
SOP's & documentation, complaints, CAPA, audits, training records, incidents & accidents and more.
Our management solution leads you to compliance with standards such as ISO/TS 16949, ISO 9001, GxP, ISO 14001 and OHSAS 18000, etc.Download Brochure Schedule Demo
ISO/TS 16949 is an ISO technical specification aimed at the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the automotive industry supply chain. It is based on the ISO 9001 standard and the first edition was published in June 1999 as ISO/TS 16949:1999.
Before the existance of the ISO/TS standard, many suppliers were asked by the car manufacturers (OEMs) to build and certify their quality management system according to the rules and regulations of their own country organizations, such as: VDA for the Germany manufacturers, QS9000 for the AIAG or FIEV (France).
But due to this regulations a subcontractor needed to provide two different certificates for Chrysler (QS9000) and Daimler (VDA 6.1), even though the subcontractor delivered only to a single company. These complexities accelerated the need for harmonization towards one single standard.
The most recent version of the ISO/TS was published in 2016: ISO/TS 16949:2016.
Our team has more than 20 years of experience implementing quality management software for the automotive industry. We help you through the smooth and painless setup of the core processes of your ISO/TS compliant QMS in our software.
- Document Control (SOP’s, work instructions and other documentation)
Automate the everyday document management processes with built-in tools such as version control, the assessment & distribution workflow, digital archive and auditable history.
- Customer complaint, supplier complaints and internal deviations
Follow your 8D-compliant workflow process from initial registration, to root cause analysis, through to final response. Manage customer resolution and ensure satisfaction.
- CAPA Management
Implement your corrective & preventative actions trough a compliant workflow process of plan, do and check.
- Incidents & Accidents
Vivaldi helps you to better track, investigate, and correct your EHS incidents to prevent or reduce the chance of recurrence.
- Risk management
Inventorize risks and embed risk management into your core Quality & EHS processes.
- Training and competencies
Manage all training data and in the central database of Vivaldi. Link competencies to training data, functions and roles and your staff.
- Management review and meetings
Centralize the records of your management reviews and meetings, including attachments and reports. Schedule and track linked corrective and preventative actions.
- Internal and external audits
Manage your internal & external audits. Ensuring your audit procedures are followed will enable confidence when facing any audits.
Automotive companies love Vivaldi Software.
Vivaldi Software has been developing Quality Management software and software for Regulatory compliance since 1995.
More than 75,000 users in the Automotive industry and other industries spread across more than 20 countries use our Quality Management Software on a daily basis.
ISO 13485 Sessions - CAPA
In the ISO 13485 video series, Victor Wong from Vivaldi Software and Verlene Law from The Reg Consultants discuss the most important changes in the latest version of the ISO 13485 standard for the Medical Device Industry. In this video Verlene and Victor discuss the CAPA process.
ISO 13485 Sessions - Customer complaints
In the ISO 13485 video series, Victor Wong from Vivaldi Software and Verlene Law from The Reg Consultants discuss the most important changes in the latest version of the ISO 13485 standard for the Medical Device Industry. In this first video Verlene and Victor discuss the Customer Complaints.