Title

Update the method of performing a management review

Why

Since phase 3 the laboratory manager and key staff need to annually review the functioning of the quality management system. This review is based on many different indicators (listed in the activity on performing management reviews in phase 3). However, later in phase 3 and in phase 4 several new procedures have been implemented that can also serve as indicators for the management review. Therefore the procedure for performing a management review needs to be adapted.

What

During the management review the Laboratory Manager reviews (in bold the items that are added in phase 4):

  • Performance data and/or information arising from internal audits and nonconformity management
  • Review of major changes in operation of the laboratory
  • Verification that the quality management system is implemented correctly and according to schedule
  • Feedback (complaints, satisfaction surveys, etc.) from staff and clients
  • Status of current continual improvement activities
  • Identification of new opportunities for improvement, including selection and prioritization of these opportunities considering availability of resources
  • Allocation of resources needed for follow-up actions from the management review


Use the following sources to get the information needed for the review (in bold the sources that became/become available in phase 4):

  • Quarterly quality reports
  • Follow-up of actions originating from the last management review
  • Follow-up of goals set in the Quality Year Plan
  • Result of the selection and assessment of suppliers to the laboratory
  • Assessment of adherence to turnaround times
  • Periodic review of requests and samples
  • Changes in staff and in volume and scope of work
  • The competence of personnel (competency assessments) and their training needs
  • Reports of external quality assessments
  • Reports of internal and external quality audits and the follow-up
  • Assessment of user satisfaction
  • Staff and external customer complaints, including monitoring and resolution
  • Identification, control and resolution of nonconformities, including current status of corrective and preventive actions
  • Recommendations for improvement


Adapt the SOP for Management Review.

How & who

Laboratory Manager:

  1. Adapt the SOP for Management Review according to the normal procedure described in the SOP on Document Control.

Back to Roadmap Activity Overview
This activity belongs to the QSE Organization

 

ISO15189:2007: 4.15.1 4.15.2 4.15.3 4.15.4
ISO15189:2012: 4.15.1 4.15.2 4.15.3 4.15.4
ISO15190:2003: