ISO 15189 medical laboratories training courses

ISO 15189 Awareness

Staff and stakeholders who need an introduction to medical laboratories and their responsibilities.

Learning focus

Recognise the purpose of ISO 15189, the importance of competence and impartiality, and how your role supports consistent results.

Programme outline

• ISO 15189 requirements for medical laboratories: medical-laboratory quality and competence, pre-examination, examination and post-examination processes, and patient-focused risk.
• Roles, responsibilities and an introduction to evidence of conformity.
• Practical examples and an awareness review.

ISO 15189 Foundation

Staff, managers and prospective assessors building a working understanding of ISO 15189.

Learning focus

Interpret the main requirements and identify the procedures, records and competence evidence relevant to medical laboratories.

Programme outline

• ISO 15189 requirements for medical laboratories: medical-laboratory quality and competence, pre-examination, examination and post-examination processes, and patient-focused risk.
• Documented processes, competence records and evidence of implementation.
• Requirement-to-evidence exercises and foundation review.

ISO 15189 Internal Auditor

Personnel planning internal audits of medical laboratories against ISO 15189.

Learning focus

Plan a risk-based internal audit, gather objective evidence, report findings and follow up corrective action.

Programme outline

• ISO 15189 requirements for medical laboratories: medical-laboratory quality and competence, pre-examination, examination and post-examination processes, and patient-focused risk.
• Internal audit scope, programme, checklists, interviewing and sampling.
• Findings, reporting, corrective action and follow-up exercises.

ISO 15189 Lead Assessor

Assessors and team leaders evaluating the competence and conformity of medical laboratories.

Learning focus

Plan and lead a ISO 15189 assessment team, evaluate technical and management evidence, and communicate defensible findings.

Programme outline

• ISO 15189 requirements for medical laboratories: medical-laboratory quality and competence, pre-examination, examination and post-examination processes, and patient-focused risk.
• Assessment planning, team responsibilities and competence evaluation.
• Evidence sampling, observation, interviewing, findings and assessment reporting.

Existing course prices apply. View course details or contact Cognicert for fees.

ISO 15189 Lead Implementer

Managers and implementation leads establishing or improving processes for medical laboratories.

Learning focus

Develop a ISO 15189 implementation plan, define responsibilities, prepare evidence and review readiness for assessment.

Programme outline

• ISO 15189 requirements for medical laboratories: medical-laboratory quality and competence, pre-examination, examination and post-examination processes, and patient-focused risk.
• Gap analysis, implementation planning, resources and documented controls.
• Performance evaluation, internal audit, management review and assessment readiness.

Existing course prices apply. View course details or contact Cognicert for fees.