ISO 15189 Trainings

Laboratory manager and Internal auditor of quality management system in laboratory according to  ISO 15189

Comprehensive training preparing for the implementation and auditing of the quality management system in a laboratory compliant with the ISO 15189 standard. The training gives the right to perform the functions of the Laboratory Manager for QMS and the ISO 15189 Internal Auditor. A detailed description of the requirements of ISO 15189 allows participation in the training even by people who are just starting their adventure with medical laboratory certification. It will also be a great reminder and broadening of knowledge for people already working in an accredited laboratory.

Time:

3 days

 Participant profile:

  • Medical laboratory managers
  • Technical management
  • Laboratory staff

Training form:

Lectures and a seminar interspersed with practical exercises related strictly to the laboratory accreditation and functioning of management and auditors in the quality management system in laboratory.

Trainers:

Our trainers have many years of practical experience in implementing, auditing and developing quality management systems in laboratory.

Dates:

If you need training for Laboratory Manager and/or Auditor of Medical Laboratory contact us to arrange a date, we will adapt it to your needs.

Benefits

  • participation in training in a small group
  • qualifications to perform the functions of: Medical Laboratory Manager for Quality (Laboratory Manager ISO 15189, ISO 15189 Quality Manager) and Internal Auditor of the Quality Management System in accordance with ISO 15189
  • certificate of participation in the training
  • after successfully passing the exam, the certificate of the Quality Manager and Internal Auditor ISO 15189
  • practical knowledge supported by numerous exercises carried out during the training
  • consultations with the Trainer (during the training) on topics related to the topic of the training

Training schedule

Day 1:

  • Presentation of the ISO 15189 standard in terms of system and technical requirements.
  • Mutual recognition system in the world and in Poland and the role of laboratory accreditation in the system.
  • Identification and practical presentation of formal requirements for the accreditation of a research or calibration laboratory.
  • Lab policies. Principles of non-involvement, transparency of proceedings.
  • Laboratory management system requirements. Documentation of the management system in the Laboratory.

Day 2:

  • Medical diagnostic laboratories – their goals, tasks and specificity in the organizational level of health protection.
  • ISO 15189 requirements.
  • Requirements for laboratory personnel.
    Determining the minimum competencies for managerial staff, laboratory technicians, support staff. Managing personnel competencies
    Planning and implementation of training.
  • Requirements for laboratory equipment, operation and maintenance.
  • Operation and maintenance of control and measurement equipment. Ensuring metrological consistency with respect to physical, chemical and biological standards.
  • Identification of requirements for test methods.
  • Correct implementation of the study from the customer’s submission to the release of the results.
  • Quality management in laboratories.
  • Methodology of developing the documentation of the Management System.
  • Role and tasks of the Quality System Representative in a medical diagnostic laboratory.
  • Creation and supervision of the quality system documentation (book, procedures, instructions).

Day 3:

  • Management of the audit program of testing / calibration laboratories based on ISO 15189
  • Selection of audit staff for the laboratory. Planning and supervision over the implementation of audits
  • Requirements for auditors and preparation for conducting a system audit in a laboratory operating on the basis of the ISO 15189 standard
  • Methods for auditing, gathering information and formulating audit findings. Conducting an audit of the management system in the laboratory
  • Audit reporting
  • Implementation of audit follow-up
  • Audit effectiveness review
  • Preparation for the audit by the Polish Center for Accreditation or an interested party
  • Exam

 

Cost

Net price:

  • 700 €/person. – on-site trainings
  • 650 €/person. – on-line trainings

Additionally, it is possible to book an overnight stay. Accommodation for training participants is booked in cozy hotels near the training place.

Training prices include

  • participation in training
  • training materials made available to participants by e-mail
  • consultations with the Trainer (during the training) on topics related to the topic of the training
  • lunches during the training and coffee snacks (for open class training)

Accommodation can be booked for an additional fee. Accommodation for training participants is booked in cozy hotels near the training place.
 

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