ISO 9001 is the ISO standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
A lot of industry-specific quality management standards have been derived from the ISO 9001 standard such as the ISO/TS 16949 for the Automotive industry, AS9100 for the Aerospace industry, the ISO 17025 for Laboratories and ISO 15189 for Medical laboratories, the ISO 22000 for the Food & Beverage industry and the ISO 13485 for Medical devices (Life sciences).
ISO 14001 is the international standard that specifies requirements for an effective environmental management system (EMS). It provides a framework that an organization can follow, rather than establishing environmental performance requirements.
OHSAS 18001, Occupational Health and Safety Assessment Series, is an internationally applied British Standard for occupational health and safety management systems. It exists to help all kinds of organizations put in place demonstrably sound occupational health and safety performance. It is a widely recognized and popular occupational health and safety management system.
Our team has more than 20 years of experience implementing management software for quality, safety, health and environment. We help you through the smooth and painless setup of the core processes of your ISO, OHSAS and GxP compliant management system 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 complaints workflow process from initial registration 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.
Manufacturing companies love Vivaldi Software.
Vivaldi Software has been developing Quality & EHS Management software and software for Regulatory compliance since 1995.
More than 75,000 users in manufacturing and other industries spread across more than 20 countries use our Quality & EHS 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.