Holistic Quality Management for the Healthcare Sector

Overview

Healthcare services including Medical laboratories, Imaging and physiological science (incl. audiology, cardiology and respiratory) and affiliated healthcare service providers need to have sound mechanisms to enable them to deliver technically valid services and examination results to their users and patients. When such organisations seek to have their competence recognised through accreditation by UKAS, these processes should also enable the healthcare providers to demonstrate that they meet the requirements for an effective quality management system (as well as conformance with ISO 15189). This course provides key elements of the Laboratory Internal Audit course and effective Laboratory Management subject matter in relation to healthcare standards.

Participation in this course will develop skills and competence for various staff roles, including those responsible for quality management & coordination, technical leads or service management within an organisation.

Course Objectives

Learners will develop an understanding how the organisational processes of a healthcare service provider can be combined effectively with the requirements of ISO 15189, IQIPS v2.0 and QSI 2019. They will appreciate how effective service management can be integrated with principles in key areas of compliance. This will include robust internal audit processes, competence development, non-conformance analysis, management review and their value to excellent service provision. The application of these tools will enhance the delivery of the service for its users and in turn assist in the conformance with the requirements of Healthcare standards.

By the end of this course, delegates will:

Key Topics

• Framework for business processes
  • Background on healthcare standards
  • Technical & Quality Management roles and responsibilities
• Internal audit principles, tools, reports and value
• Service & facility selection and resourcing
  • Including environmental and equipment selection, metrological traceability, external services and supplies
• Activity evaluation for fitness for purpose
  • Validation & verification and evaluation of measurement uncertainty
• Personnel
  • Including defining responsibilities, qualifications and competence
• QMS principles & design
  • Including documentation and control of records, risk review and improvement opportunities
• Validity of results
  • Including quality assurance and reporting
• Management of non-conforming work
  • Including complaints, errors and incidents
• Management review function and value

Who should attend

This course is aimed at personnel from accredited or applicant laboratories within healthcare services, including those who are accredited to ISO 15189, QSI 2019 [formally ISAS] and IQIPS v2.0. It may be of value for personnel who have responsibility for:

• Service/organisational management and oversight
• Technical service performance of the examinations applied

Maintenance of the quality management systems of the services delivered

Meet the trainers

This course is delivered by:

Darren Edwards Having joined UKAS in 2007, Darren is a highly experienced Assessment Manager and Lead Assessor of medical laboratories. Darren has an expert knowledge of the requirements of ISO 15189 and ISO 17043 and how they are interpreted by UKAS. Darren holds a BSc in Microbiology and an MSc in Quality Management and Improvement.

Dates and locations

Bookings