Podcast
Questions and Answers
What should the laboratory do when it finds out that nonconformities could recur?
What should the laboratory do when it finds out that nonconformities could recur?
- Report the nonconformities to the authorities
- Ignore the nonconformities and continue with the process
- Stop the examination process
- Take action to identify, document and eliminate the cause(s) (correct)
When should the laboratory take action to identify the cause of nonconformities?
When should the laboratory take action to identify the cause of nonconformities?
- When the nonconformities are detected during the post-examination process
- When the nonconformities are minor
- When the nonconformities are detected during the pre-examination process
- When it is determined that nonconformities could recur or there is doubt about compliance (correct)
What is the primary reason for the laboratory to take action?
What is the primary reason for the laboratory to take action?
- To prevent nonconformities from recurring (correct)
- To increase efficiency
- To improve its reputation
- To reduce costs
What should the laboratory document?
What should the laboratory document?
What is the ultimate goal of the laboratory's action?
What is the ultimate goal of the laboratory's action?
What is implied by the phrase 'doubt about the laboratory's compliance with its own procedures'?
What is implied by the phrase 'doubt about the laboratory's compliance with its own procedures'?
When is the laboratory required to take action?
When is the laboratory required to take action?
What is the laboratory's responsibility in case of nonconformities?
What is the laboratory's responsibility in case of nonconformities?
What is the focus of the laboratory's action?
What is the focus of the laboratory's action?
What is the outcome of the laboratory's action?
What is the outcome of the laboratory's action?
Flashcards
Recurring Nonconformities
Recurring Nonconformities
Nonconformities that have the potential to happen again.
Identify Causes
Identify Causes
Figure out why nonconformities happen.
Document Causes
Document Causes
Keep records of why nonconformities occurred.
Eliminate Causes
Eliminate Causes
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Doubtful Compliance
Doubtful Compliance
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Laboratory Action
Laboratory Action
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Nonconformity
Nonconformity
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Prevent Recurrence
Prevent Recurrence
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Compliance
Compliance
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Action Trigger
Action Trigger
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Study Notes
Laboratory Management
- The laboratory shall define its quality management system's intent in a quality policy.
Document Control
- Changes to documents are identified.
- Documents remain legible.
- Documents are periodically reviewed and updated at a frequency that ensures they remain fit for purpose.
Supplier Management
- The laboratory shall monitor the performance of suppliers to ensure that purchased services or items consistently meet the stated criteria.
Advisory Services
- The laboratory shall establish arrangements for communicating with users on:
- Advising on choice of examinations and use of services.
- Advising on individual clinical cases.
- Professional judgments on the interpretation of examination results.
- Promoting the effective utilization of laboratory services.
- Consulting on scientific and logistic matters.
Complaint Resolution
- The laboratory shall have a documented procedure for the management of complaints or other feedback received from clinicians, patients, laboratory staff, or other parties.
Nonconformity Management
- The laboratory shall take action to identify, document, and eliminate the cause(s) of nonconformities in pre-examination, examination, and post-examination processes that could recur or raise doubts about the laboratory's compliance with its own procedures.
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Description
Test your knowledge on the quality policy and laboratory management as outlined in the ISO 17025 standard. Understand the intent of a quality management system and its implementation in a laboratory setting. This quiz is ideal for laboratory professionals and quality management system auditors.
