ISO/IEC 17025 is the main ISO standard used by testing, calibration and forensic laboratories. In most major countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test, forensic or calibration results from a lab that is not accredited.
ISO 15189 is a standard that specifies the quality management system requirements particular to medical laboratories. The standard is based on the details of ISO/IEC 17025:1999, with addition of advice to medical laboratory users. This includes requirements towards the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab's role in the education and training of health care staff.
While the ISO 15189 standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care. The first version of the ISO 15189 was published in 2003, and it was revised in 2007 to align more closely to ISO/IEC 17025. A third edition of the standard was published in 2012, which revised the layout again and added a section on laboratory information management.
Our team has more than 20 years of experience implementing quality management software for the laboratory industry. We help you through the smooth and painless setup of the core processes of your ISO and GxP 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 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.
Clinical, medical and industrial laboratories love Vivaldi Software.
Vivaldi Software has been developing Quality Management software and software for Regulatory compliance since 1995.
More than 75,000 users in laboratories 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.