T 90v22 - E-Learning - ISO 15189 training package - Readiness and internal audit of your medical laboratory management system MS version 2022

Course objectives: Essential for any organization in the medical laboratory sector wishing to:

• access international markets (and comply with legal obligations)
• secure its processes
• demonstrate its commitment to quality and patient safety
• master the specific requirements for medical laboratories (traceability, risk management, regulatory compliance)
• reduce risks for patients, users and personnel (contamination)
• prepare for ISO 15189 accreditation
• reduce the risk of patient complaints
• evaluate the performance of the medical laboratory management system through internal audits

Free quiz without registration on the requirements of the ISO 15189 standard that you can exercise by clicking on the "QUIZ" button:

• Quiz requirements ISO 15189 version 2022

Readiness for implementation, accreditation, maintenance and improvement of your management system ISO 15189 in order to:

• meet applicable regulatory requirements
• built patient confidence
• optimize operational processes
• increase the satisfaction of stakeholders

To conduct an audit according to ISO 19011 in order to:

• identify improvement opportunities
• increase the satisfaction of stakeholders
• evaluate the performance of the ISO 15189 management system

See the set of documents  ISO 15189 medical laboratory package MS version 2022 

T 65v22 ONLINE TRAINING ISO 15189 readiness version 2022 

Discover the ISO 15189 standard and

• its contents
• its principles
• its requirements
• its stakes

Get used to

• process approach
• medical laboratory terminology
• medical laboratory documents
• ISO 15189 readiness documentation
• ISO 15189 internal audit documentation
• risk approach
• improvement
• feedback

The important and fundamental elements of a medical laboratory management system

• quality approach (quality management principles, PDCA cycle)
• standards and specifications
• process approach (definitions, process types, mapping)
• general requirements
• structure and governance
• resources
• examination processes
• management syste
• POCT
• risks and opportunities
• resources, communication, documents
• production and service provision
• performance evaluation
• improvement

The menu of the course

• Presentation
• MCT (multiple-choice test) Beginning (10 questions)
• 1 Medical biology laboratory (MBL)
  • 1.1 History
  • 1.2 Scope
  • 1.3 Benefits
  • 1.4 Principles and steps
• 2 Definitions, standards and books
  • 2.1 Definitions
  • 2.2 Standards
  • 2.3 Books
• MCT MBL (7 questions)
• 3 Process approach
  • 3.1 Types of processes
  • 3.2 Process mapping
  • 3.3 Process approach
• MCT Process approach (7 questions)
• 4 General requirements
  • 4.1 Impartiality
  • 4.2 Confidentiality
  • 4.3 Patient requirements
• Case Customer and needs
• Summary of clause 4
• MCT General requirements (8 questions)
• 5 Structure and governance
  • 5.1 Legal entity
  • 5.2 Laboratory director
  • 5.3 Laboratory activities
  • 5.4 Structure and authority
  • 5.5 Policy and objectives
  • 5.6 Risk management
• Case Quality policy
• Case Communication
• Summary of clause 5
• MCT Structure and governance (8 questions)
• 6 Resources
  • 6.1 General
  • 6.2 Personnel
  • 6.3 Facilities
  • 6.4 Equipment
  • 6.5 Calibration and traceability
  • 6.6 Reagents and consumables
  • 6.7 Contracts
  • 6.8 External providers
• Case Importance of work
• Case Supplier selection
• Summary of clause 6
• MCT Resources (7 questions)
• 7 Processes
  • 7.1 Process requirements
  • 7.2 Pre-examination processes
  • 7.3 Examination processes
  • 7.4 Post-examination processes
  • 7.5 Nonconforming work
  • 7.6 Data control
  • 7.7 Complaints
  • 7.8 Business continuity
• Case Acceptance criteria
• Summary of clause 7
• MCT Processes (8 questions)
• 8 Management system
  • 8.1 General requirements
  • 8.2 Documentation
  • 8.3 Document control
  • 8.4 Record control
  • 8.5 Actions to address risks
  • 8.6 Improvement
  • 8.7 Nonconformities
  • 8.8 Evaluations
  • 8.9 Management review
• Case Document control
• Case New risk
• Case Risk register
• Case Risk treatment
• Case Task priority
• Case Nonconformities
• Case Kaizen & problem-solving
• Case Audit preparation
• Case Auditor question
• Case Audit program
• Case Audit report
• Case Management review
• Summary of clause 8
• MCT Management system (7 questions)
• Annex A POCT
• Summary of Annex A
• MCT POCT (8 questions)
• MCT End (20 questions)

T 50v22 ONLINE TRAINING ISO 15189 internal audit version 2022 

The important and fundamental elements of an internal audit

• scope
• normative references
• principles
• audit program (responsibilities, records)
• audit conducting (objectives, evidence, conclusions)
• auditor competences (knowledge, training)

The menu of the course

• Presentation
• MCT (multiple-choice test) Beginning (10 questions)
• 1 Scope
• 2 Normative references
• 3 Definitions
• 4 Principles
  • 4.1 Management principles
  • 4.2 Audit principles
  • 4.3 MS performance
• MCT Internal audit (7 questions)
• 5 Audit program
  • 5.1 General
  • 5.2 Objectives
  • 5.3 Risks
  • 5.4 Establishing
  • 5.5 Implementing
  • 5.6 Monitoring
  • 5.7 Reviewing and improving
• Case New risk
• Case Audit program
• MCT Audit program (11 questions)
• 6a Audit preparation
  • 6.1 General
  • 6.2 Initiating
    • 6.2.1 First contact
    • 6.2.2 Feasibility
  • 6.3 Preparing the audit
    • 6.3.1 Document review
    • 6.3.2 Audit plan
• Case Nonconformities
• Case Audit readiness
• MCT Audit preparation (8 questions)
• 6b Coduct an audit
  • 6.4 Audit activities
    • 6.4.1 General
    • 6.4.2 Guides and observers
    • 6.4.3 Opening meeting
    • 6.4.4 Communication
    • 6.4.5 Availability and access
    • 6.4.6 Document review
    • 6.4.7 Collecting information
    • 6.4.8 Audit findings
    • 6.4.9 Audit conclusions
    • 6.4.10 Closing meeting
  • 6.5 Audit report
  • 6.6 Completing the audit
  • 6.7 Audit follow-up
• Case Audit finding
• Case External audit nonconformity
• Case Audit report
• Case Management review
• MCT Conduct an audit (8 questions)
• 7 Competence and evaluation of auditors
  • 7.1 General
  • 7.2 Auditor competence
  • 7.3 Evaluation criteria
  • 7.4 Evaluation methods
  • 7.5 Auditor evaluation
  • 7.6 Improving competence
• Case Auditor question
• Case Auditor independence
• MCT Auditor competence (7 questions)
• MCT End (20 questions)