ISO 9000 Compliance
Many organizations are deploying industry standard quality management methodologies based on ISO 9000 or related specifications developed for specific industries such as TS 16949 for the automotives industry and ISO 13485 for the medical device industry. These standards bring the organizational focus on customer satisfaction and continuous improvement and take a process-centric approach towards quality management and assurance.
MetricStream offers industry's most advanced and comprehensive suite of ISO Compliance software solutions to support ISO 9000 compliance. Leading companies are replacing their point solutions and paper-based systems with MetricStream solutions to automate their quality management processes, gain real-time visibility into their quality metrics, reduce the costs arising out of poor quality, and comply with the ISO 9000 standard.
Some of the core processes for ISO 9000 compliance which leading global companies are leveraging MetricStream ISO 9000 software solutions include:
Closed Loop Processes: Ensuring that all quality processes are well integrated to create a unified and seamless environment for quality related issues and data. MetricStream solution tracks events as they move from one stage to the next, even across departments and groups, to ensure a closed loop quality management process. For instance, a document change can initiate a training request and CAPAs triggered as a result of audit findings are tied to the audit.
Streamlined Corrective Actions: Engaging teams to collaborate on development and implementation of corrective action plans. MetricStream enables triggering CAPAs, performing root cause analysis, assigning follow up actions while effectively tracking and routing cases from initiation to closure.
Efficient Audit Management: Conducting frequent internal audits to ensure that the established product and processes quality requirements are being followed. MetricStream provides capabilities to efficiently plan, schedule and conduct audits, allows audit findings to be reviewed and analyzed by a team, enables initiation of follow-up activities such as corrective/preventive actions when needed, and provides the ability to monitor the entire process.
Implementing Document Control: Streamlining document management and control processes for documents such as SOPs, batch records, regulatory filing, and quality reports. MetricStream enables companies to adopt an electronic and automated approach to managing and control documents across the enterprise with a centralized repository and tools for collaboration.
Tracking Nonconformance: Accelerating nonconformance review and approval cycles with automated workflow. MetricStream supports recording and automatic rule-based routing of nonconformance issues for review and disposition by the Material Review Board (MRB).
Real-time Reporting: Tracking quality issue and processes in real-time on executive dashboards and reports for data driven decision-making. MetricStream provides complete visibility into quality system database with comprehensive aggregate reporting as well as individual case status tracking. Graphical executive dashboards and flexible reports with drill-down capability provide statistics, analytics and trending.
