Align with organization's purpose and strategic direction.

Quality Management System

Compliance requirements and deliver to customer expectations.

quality management system (QMS)

A set of policies, processes and procedures required for planning and execution (production/development/service) in the core business area of an organization

Establish quality program expectations and an approach to achieving targets and goals to measure specific performance against program expectations across facilities

Define corrective and preventative actions, set closure targets, ensure timely response to address actions and provide leaders with real-time visibility

Conduct mobile inspections using customized inspection checklists, establish an auditing routine and assign to managers in the facility

Enable all employees to report concerns and complaints via a simple interface and escalate key issues that require additional investigation

Perform detailed root cause analysis on identified issues and classify issues with failure and causal codes with corrective and preventative actions

Report and perform follow-up of product or service commitment defects, track product and customer details and integrate with other tools for additional analysis

Simplify the management of employee/worker training requirements using a multitier training matrix and automatic tracking of qualification status

Maintain quality management software documents in a central repository and integrate SOP references via Doc Manager integration with other Gensuite applications

Quality Management System (QMS)

  • Plan, publish, and measure facilities to established organizational quality program expectations with appropriate follow-up and responsibility tracking
  • Measure quality compliance with evolving industry standards and program expectations (e.g., ISO 9001, AS9100, GMP, TS)
  • Engage staff in key quality program activities e.g., compliance tasks, auditing, issue identification, CAPA, etc. and notify through automated alerts and reminders
  • Develop and schedule customized inspections to ensure processes and services remain in compliance
  • Record observed defects via mobile and online reporting; track and manage the RCA activities surrounding defect resolution
  • Report and analyze data and key performance indicators including ‘Cost of Quality’ by site or across the company through flexible and customizable reporting and data analytics capabilities