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NESTRA KLINIKAL

Quality Management Systems

Advanced Diploma in Quality Management Systems

In-depth mastery for senior practitioners who will lead quality function design, audit programmes and accreditation readiness within their organisations.

Level
Advanced / Diploma
Delivery
Blended (online + in person)
Certification
Nestra Klinikal Advanced Diploma in Quality Management Systems

Who this is for

  • Quality managers and heads of laboratory
  • Senior clinical research staff
  • Consultants advising on quality systems

What you will be able to do

  • Lead the design and implementation of an organisation-wide quality system
  • Run an internal audit programme against ISO 15189 or ISO 17025
  • Prepare an organisation for accreditation assessment
  • Mentor staff through a quality transformation

Curriculum

  1. 01

    Quality system architecture

    Designing a system that fits the organisation rather than a template.

  2. 02

    ISO 15189 in depth

    Requirements for medical laboratories, clause by clause.

  3. 03

    ISO 17025 in depth

    Requirements for testing and calibration laboratories, clause by clause.

  4. 04

    Audit programme management

    Building and running an audit schedule, and managing auditor competence.

  5. 05

    Accreditation readiness

    Gap analysis, remediation planning and assessment preparation.

Entry requirements

  • Completion of the core QMS/QA certificate, or demonstrable equivalent experience in a quality role