ISO 15189 2022 Medical laboratories — Requirements for quality and competence - Quality manager & Internal auditor course

1. Purpose of standardization
2. Benefits of certification

• Introduction to ISO 15189 2012 standards
• Process approach
• Risk based thinking
• PDCA
• Medical laboratory accreditation
• Benefits of medical laboratory accreditation
• International Laboratory Accreditation Corporation (ILAC)

Clause 4.1 Impartiality

Clause 4.2 Confidentiality

Clause 4.2.1 Management of information

Clause 4.2.2 Release of information

Clause 4.2.3 Personnel responsibility 

Clause 4.3 Requirements regarding patients

Clause 5.1 Legal entity

Clause 5.2 Laboratory director 

Clause 5.2.1 Laboratory director competence

Clause 5.2.2 Laboratory director responsibilities

Clause 5.2.3 Delegation of duties 

Clause 5.3 Laboratory activities

Clause 5.3.1 General

Clause 5.3.2 Conformance with requirements 

Clause 5.3.3 Advisory activities

Clause 5.4 Structure and authority 

Clause 5.4.1 General

Clause 5.4.2 Quality management

Clause 5.5 Objectives and policies

Clause 5.6 Risk management

Clause 6.1 General

Clause 6.2 Personnel

Clause 6.2.1 General

Clause 6.2.2 Competence requirements 

Clause 6.2.3 Authorization 

Clause 6.2.4 Continuing education and professional development

Clause 6.2.5 Personnel records

Clause 6.3 Facilities and environmental conditions

Clause 6.3.1 General

Clause 6.3.2 Facility controls

Clause 6.3.3 Storage facilities 

Clause 6.3.4 Personnel facilities 

Clause 6.3.5 Sample collection facilities

Clause 6.4 Equipment

Clause 6.4.1 General

Clause 6.4.2 Equipment requirements

Clause 6.4.3 Equipment acceptance procedure 

Clause 6.4.4 Equipment instructions for use 

Clause 6.4.5 Equipment maintenance and repair 

Clause 6.4.6 Equipment adverse incident reporting

Clause 6.4.7 Equipment records

Clause 6.5 Equipment calibration and metrological traceability 

Clause 6.5.1 General

Clause 6.5.2 Equipment calibration

Clause 6.5.3 Metrological traceability of measurement results 

Clause 6.6 Reagents and consumables 

Clause 6.6.1 General

Clause 6.6.2 Reagents and consumables — Receipt and storage

Clause 6.6.3 Reagents and consumables — Acceptance testing

Clause 6.6.4 Reagents and consumables — Inventory management

Clause 6.6.5 Reagents and consumables — Instructions for use

Clause 6.6.6 Reagents and consumables — Adverse incident reporting 

Clause 6.6.7 Reagents and consumables — Records 

Clause 6.7 Service agreements....

Clause 6.7.1 Agreements with laboratory users

Clause 6.7.2 Agreements with POCT operators

Clause 6.8 Externally provided products and services 

Clause 6.8.1 General

Clause 6.8.2 Referral laboratories and consultants

Clause 6.8.3 Review and approval of externally provided products and services

Clause 7.1 General

Clause 7.2 Pre-examination processes

Clause 7.2.1 General

Clause 7.2.2 Laboratory information for patients and users

Clause 7.2.3 Requests for providing laboratory examinations

Clause 7.2.4 Primary sample collection and handling

Clause 7.2.5 Sample transportation

Clause 7.2.6 Sample receipt

Clause 7.2.7 Pre-examination handling, preparation, and storage

Clause 7.3 Examination processes

Clause 7.3.1 General

Clause 7.3.2 Verification of examination methods

Clause 7.3.3 Validation of examination methods 

Clause 7.3.4 Evaluation of measurement uncertainty (MU)

Clause 7.3.5 Biological reference intervals and clinical decision limits

Clause 7.3.6 Documentation of examination procedures

Clause 7.3.7 Ensuring the validity of examination results

Clause 7.4 Post-examination processes

Clause 7.4.1 Result reporting

Clause 7.4.2 Post-examination handling of samples 

Clause 7.5 Nonconforming work

Clause 7.6 Control of data and information management

Clause 7.6.1 General

Clause 7.6.2 Authorities and responsibilities for information management

Clause 7.6.3 Information systems management

Clause 7.6.4 Downtime plans

Clause 7.6.5 Off site management

Clause 7.7 Complaints

Clause 7.7.1 Process 

Clause 7.7.2 Receipt of complaint

Clause 7.7.3 Resolution of complaint

Clause 7.8 Continuity and emergency preparedness planning

Clause 8.1 General requirements 

Clause 8.1.1 General

Clause 8.1.2 Fulfilment of management system requirements 

Clause 8.1.3 Management system awareness

Clause 8.2 Management system documentation 

Clause 8.2.1 General

Clause 8.2.2 Competence and quality

Clause 8.2.3 Evidence of commitment

Clause 8.2.4 Documentation

Clause 8.2.5 Personnel access

Clause 8.3 Control of management system documents

Clause 8.3.1 General

Clause 8.3.2 Control of documents

Clause 8.4 Control of records

Clause 8.4.1 Creation of records

Clause 8.4.2 Amendment of records 

Clause 8.4.3 Retention of records

Clause 8.5 Actions to address risks and opportunities for improvement

Clause 8.5.1 Identification of risks and opportunities for improvement

Clause 8.5.2 Acting on risks and opportunities for improvement

Clause 8.6 Improvement

Clause 8.6.1 Continual improvement

Clause 8.6.2 Laboratory patients, user, and personnel feedback

Clause 8.7 Nonconformities and corrective actions

Clause 8.7.1 Actions when nonconformity occurs 

Clause 8.7.2 Corrective action effectiveness

Clause 8.7.3 Records of nonconformities and corrective actions

Clause 8.8 Evaluations 

Clause 8.8.1 General

Clause 8.8.2 Quality indicators

Clause 8.8.3 Internal audits

Clause 8.9 Management reviews

Clause 8.9.1 General

Clause 8.9.2 Review input

Clause 8.9.3 Review output

• Laboratory safety
• Recognition of hazards
• Assess risks
• Minimize Risks
• Prepare for emergencies
• Safe laboratory practices
• Immunization
• Laboratory safety guidelines
• Action plan

• Building the culture
• Plan-Do-Check-Act

• Leadership concepts
• Role of leaders in implementing the management system
• 12 Characteristics of team leaders and managers

• Employee wants
• Achieving a motivated workforce

• Inability to manage the change
• No planned review of the system
• Inadequate planning
• Not aligning the goals and matrices
• Poor commitment from top management
• Differences between departments and individuals
• Lack of awareness and not providing continuous training
• Poor documentation
• Inadequate monitoring, measuring and analysis of data and results
• Not paying attention to internal and external customers
• Failure to continually improve
• Failure to motivate and empower employees

1. Scope
2. Normative references
3. Terms and definitions

1. Establishing audit programme objectives
2. Determining and evaluating audit programme risks and opportunities
3. Establishing the audit programme
4. Roles and responsibilities of the individual(s) managing the audit programme
5. Competence of individual(s) managing audit programme
6. Establishing extent of audit programme
7. Determining audit programme resources
8. Implementing audit programme
9. Defining the objectives, scope and criteria for an individual audit
10. Selecting and determining audit methods
11. Selecting audit team members
12. Assigning responsibility for an individual audit to the audit team leader
13. Managing audit programme results
14. Managing and maintaining audit programme records
15. Monitoring audit programme
16. Reviewing and improving audit programme

1. Initiating audit
2. Establishing contact with auditee
3. Determining feasibility of audit
4. Preparing audit activities
5. Performing review of documented information
6. Audit planning
7. Assigning work to audit team
8. Preparing documented information for audit
9. Conducting audit activities
10. Assigning roles and responsibilities of guides and observers
11. Conducting opening meeting
12. Communicating during audit
13. Audit information availability and access
14. Reviewing documented information while conducting audit
15. Collecting and verifying information
16. Generating audit findings
17. Determining audit conclusions
18. Conducting closing meeting
19. Preparing and distributing audit report
20. Preparing audit report
21. Distributing audit report
22. Completing audit
23. Conducting audit follow-up

1. Determining auditor competence
2. Personal behavior
3. Knowledge and skills
4. Achieving auditor competence
5. Achieving audit team leader competence
6. Establishing auditor evaluation criteria
7. Selecting appropriate auditor evaluation method
8. Conducting auditor evaluation
9. Maintaining and improving auditor competence

• Exam duration is 45 minutes

• All questions carry 1 mark each

• Select only the most appropriate answer

• Minimum pass mark is 50%

• You have 3 attempts to pass the exam

• Exam duration is 45 minutes

• All questions carry 1 mark each

• Select only the most appropriate answer

• Minimum pass mark is 50%

• You have 3 attempts to pass the exam

• Exam duration is 60 minutes

• All questions carry 1 mark each

• Select only the most appropriate answer

• Minimum pass mark is 50%

• You have 3 attempts to pass the exam