Podcast
Questions and Answers
What is the correct retention period for records?
What is the correct retention period for records?
- 5 years (correct)
- Indefinitely
- 3 years
- 7 years
Which clause addresses the control of records?
Which clause addresses the control of records?
- 4.3
- 8.4
- 4.13
- 8.14 (correct)
Which clause addresses evaluations?
Which clause addresses evaluations?
- 4.14
- 8.8 (correct)
- 4.15
- 8.9
Assessment of user feedback has been retitled as what?
Assessment of user feedback has been retitled as what?
Which clause is concerned with management review?
Which clause is concerned with management review?
Which clause addresses retention and environmental conditions?
Which clause addresses retention and environmental conditions?
What clause addresses calibration, traceability, and recall?
What clause addresses calibration, traceability, and recall?
What clause addresses pre-examination process?
What clause addresses pre-examination process?
When are recalibration records updated?
When are recalibration records updated?
Measurement of uncertainty is described by which clause?
Measurement of uncertainty is described by which clause?
What clause addresses the quality of the examination process?
What clause addresses the quality of the examination process?
When can results be released and competent?
When can results be released and competent?
Which clause addresses the reporting of results?
Which clause addresses the reporting of results?
Which clause pertains to the storage, retention, and disposal of clinical samples?
Which clause pertains to the storage, retention, and disposal of clinical samples?
Laboratory control of data and information management systems might utilize which system?
Laboratory control of data and information management systems might utilize which system?
What does Clause 4.1 address?
What does Clause 4.1 address?
Which of the following options represents all policies?
Which of the following options represents all policies?
How many REQUIREMENTS clauses are detailed in ISO 15189:2022?
How many REQUIREMENTS clauses are detailed in ISO 15189:2022?
Which clauses cover technical requirements in ISO 15189:2022?
Which clauses cover technical requirements in ISO 15189:2022?
What does Clause 4.2 address?
What does Clause 4.2 address?
Which clause addresses immediate action to be taken by the referral laboratory?
Which clause addresses immediate action to be taken by the referral laboratory?
Which clause is related to external services and supplies?
Which clause is related to external services and supplies?
Which clause specifically deals with nonconforming work?
Which clause specifically deals with nonconforming work?
Which clause provides guidance on immediate action for advising on advisory services?
Which clause provides guidance on immediate action for advising on advisory services?
Which clause focuses on corrective action for opportunities for improvement?
Which clause focuses on corrective action for opportunities for improvement?
Which clause addresses the examination by referral laboratories?
Which clause addresses the examination by referral laboratories?
Which clause outlines advisory services related to complaints?
Which clause outlines advisory services related to complaints?
Which clause helps prevent the recurrence of a potential nonconformance (NC)?
Which clause helps prevent the recurrence of a potential nonconformance (NC)?
What does ISO stand for?
What does ISO stand for?
What does the term 'shall' indicate?
What does the term 'shall' indicate?
What does competence mean in this context?
What does competence mean in this context?
Which edition of ISO 15189 is current as of now?
Which edition of ISO 15189 is current as of now?
What is the purpose of ISO 15189:2022?
What is the purpose of ISO 15189:2022?
What is one of the main responsibilities of laboratory management?
What is one of the main responsibilities of laboratory management?
In which clause are the quality objectives addressed?
In which clause are the quality objectives addressed?
Which clause pertains to document control?
Which clause pertains to document control?
Who must approve all documents in the quality management system?
Who must approve all documents in the quality management system?
What does the service agreement in clause 6.7 address?
What does the service agreement in clause 6.7 address?
Flashcards
ISO 15189:2022
ISO 15189:2022
Specifies quality and competence requirements for medical laboratories.
Clause 5.4
Clause 5.4
Covers retention and environmental conditions for records.
Clause 5.6
Clause 5.6
Details calibration, traceability, and recall procedures.
Recalibration
Recalibration
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Clause 5.2
Clause 5.2
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Clause 5.5
Clause 5.5
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Clause 7.0
Clause 7.0
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Records Creation
Records Creation
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Record Retention
Record Retention
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Clause 4.3
Clause 4.3
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Evaluations
Evaluations
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User Feedback
User Feedback
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Clause 7.1
Clause 7.1
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Internal Audits
Internal Audits
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Job Profiles
Job Profiles
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Management Review
Management Review
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External Organizations
External Organizations
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Nonconforming Work
Nonconforming Work
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Examination Processes (quality)
Examination Processes (quality)
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Result Reporting
Result Reporting
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Management Systems
Management Systems
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Document Control
Document Control
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Mandatory Requirement
Mandatory Requirement
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Competence
Competence
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Quality Management System Document Approval
Quality Management System Document Approval
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Study Notes
Multiple Choice Questions Summary
- Clause addressing accuracy of use is linked to ISO/IEC 17025.
- Retention and environmental conditions are covered in clause 5.4.
- Retention of records must consider legal requirements, reference materials, and validation methods.
- Calibration, traceability, and recall are detailed in clause 5.6.
- Recalibration is recorded when technological changes occur.
- The pre-examination process is specified in clause 5.2.
- The examination process is primarily detailed in clause 5.5.
- Measurement of uncertainty is addressed in clause 7.0.
Records Management
- Records should be created by trained, competent individuals.
- Records must be retained for at least five years and created at the time of activity.
- Control of records falls under clause 4.3.
Evaluations and Feedback
- Evaluations are specified in clauses 8.8 and 4.14.
- Assessment of user feedback is retitled to include laboratory patients, users, and personnel feedback.
Risk Management and Audit Procedures
- Risk management is outlined with all options being correct in clause 7.1.
- Internal audits are addressed in clause 8.8.3.
Job Descriptions and Management Reviews
- Job descriptions have been replaced by job profiles and position descriptions.
- Management review processes are detailed in clause 8.10.
External Laboratory Processes
- External organizations performing examinations refer to clauses 4.7 and 4.8.
- Nonconforming work is detailed in clause 4.9.
Quality in Examination Procedures
- Quality of examination processes is outlined in clause 5.6.
- Reporting of results is managed under clause 7.2.
ISO 15189 Overview
- ISO 15189:2022 specifies requirements for quality and competence in medical laboratories.
- Management systems requirements are detailed in clauses 4, 5, and 8.
- Document control is addressed across several clauses, particularly 4.3 and 8.4.
Clarifications on Terminology
- The term "Shall" indicates a mandatory requirement in ISO standards.
- Competence refers to demonstrating the ability to apply knowledge and skills.
- All issued quality management system documents must be approved by competent personnel.
Conclusion
- The information pertains to understanding and applying standards in laboratory practices, especially relating to quality management, record-keeping, risk management, and procedural compliance.
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Description
Test your knowledge on the ISO/IEC 17025 standard with these multiple choice questions. Each question addresses specific clauses related to the accuracy of use, retention, and environmental conditions. Perfect for those studying quality management and laboratory accreditation.
