Drive for results (service, quality, and continuous improvement) ensure procedures and processes are in place that lead to delivery of quality results and continually reassess the effectiveness to achieve continuous improvement.

More Uses of the ISO 15189 Toolkit:

  • Warrant that your organization develops and maintains organized records that demonstrate compliance to all organization processes, regulations, and your organizations QMS.
  • Confirm your organization ensures department metrics are gathered, analyzed and reported concerning the status of department operations.
  • Develop and maintain organized records that demonstrate compliance to all organization processes, regulations, and your organizations QMS.
  • Integrate laboratory information management systems (lims) with automated systems using api calls.
  • Support the implementation and sustainment of the Quality Management System.
  • Audit: conduct departmental meetings and ensures appropriate departmental communication.
  • Initiate: direct and delegate quality assurance workflows, tasks and special projects.
  • Confirm your organization ensures compliance to applicable policies and procedures by laboratory personnel.
  • Be certain that your organization fosters a unified culture and promote a positive work environment by collaboration, cooperation, sharing of information and mutual teamwork.
  • Secure that your organization performs trending analysis (Quality Metrics) on a routine basis by identifying, generating and publishing metrics and reports related to the Quality System performance and reporting anomalies to management.
  • Confirm your organization participates in inspection readiness activities and is significantly involved in inspections by regulatory departments.
  • Ensure that all work performed by external contractors is completed and documented in accordance with IT quality system in coordination with equipment management.
  • Perform trending analysis (Quality Metrics) on a routine basis by identifying, generating and publishing metrics and reports related to the Quality System performance and reporting anomalies to management.
  • Secure that your organization attends department meetings and organization in service trainings to improve knowledge on testing and systems.
  • Ensure personnel competency and address performance related issues as necessary.
  • Collaborate with other members of management to formulate and establish quality and regulatory compliant policies/procedures/goals for your organization business.
  • Manage a team of direct reports and provide applicable guidance, coaching, hiring and evaluation for quality assurance.
  • Confirm your organization ensures that all policies, procedures, and records are reviewed and approved.
  • Secure that your organization performs staining; routine and special stains efficiently with highest quality.
  • Provide guidance on quality system use to laboratory personnel to improve and ensure compliance.
  • Supervise: work closely with the quality and regulatory teams to performance qualify any new or relocated equipment.
  • Investigate deviations from established procedures to ensure effective corrective action.
  • Drive for results and continual improvement ensure procedures and processes are in place that lead to the delivery of quality results and continually assess the effectiveness to drive continual improvement.
  • Perform sample issue investigation and resolution to support Sample Operations.
  • Systematize: effectively manage change, facilitate innovation and foster teambuilding to provide the highest quality and most cost effective laboratory product possible.

 

Categories: Articles