Standards
Quality Principles
Verification
Documents and Records
Validation
100

Why do we have ISO standards? 

  • To set international criteria for laboratory quality management
100

Who is responsible for signing the quality policy of the laboratory?

  • Appropriate lab management
100

TRUE or FALSE 

The laboratory shall obtain information from the manufacturer/method developer for confirming the performance characteristics of the procedure.

TRUE 5.5.1.2

100

What do you call documents that contain written step-by step instructions that laboratory staff should meticulously follow when performing a procedure?

SOP

100

TRUE or FALSE

The specified requirements (performance specification) for each examination procedure shall relate to the intended use of the examination.

 5.5.1.2  True

200

True or False: Can countries have national standards for laboratories?

True

200

What does quality focus on?

  • Customer satisfaction
200

True or False: Does each critical process of your laboratory need indicators?

  • True
200

How many versions should a quality manual have?

1

200

TRUE or FALSE 

The laboratory shall document the procedure used for the validation and record the results obtained. Who is responsible for reviewing validation results and recording the review process? 

Staff with authority 5.5.1.3

300

True or False: Are there currently any ISO standards for biosafety and biosecurity?

False (not published yet)

300
  • DOUBLE JEOPARDY! 
    What are the 3 methods of external quality assessment? 
  • Proficiency testing, external audit, retesting/rechecking
300

True or False: The laboratory does not need to periodically review its sample volume, collection device and preservative requirements for blood, urine, other body fluids, tissue and other sample types

  • False (4.14.2)
300

What is the difference between documents and records?

  • Documents need updating and are there for communicating information
  • Records capture information and are permanent
300
  • True or False: Personnel immunisation status, even when relevant to assigned duties, is considered private information and should not be included in personnel records
  • False (5.1.9)
400
  • Which standard in the following is a certification standard and not accreditation standard? 
  • ISO 15189, ISO 9001, ISO 17024

ISO 9001

400

What are the steps taken during the generation of a product or service to ensure product/service quality?

  • Quality Control
400

Which indicator is compulsory according to ISO 15189:2012?

  • Turnaround time
400
  • When can one allow amendment of documents by hand pending the reissue of documents?
  • Yes, if it is clearly stated in the procedure, that the amendment is clearly marked, initialed and dated that such amendments are allowed
400
  • What should a job description include? 
  • The laboratory shall have job descriptions that describe responsibilities, authorities and all tasks for all personnel
500

Which standards are applied to laboratories (list at least 4)

  • ISO 15189, ISO 17025, ISO 17043, ISO 9001
500

What is the continuous improvement cycle in quality management?

  • Plan – Do – Check – Act
500

According to ISO what are you suppose to do with staff suggestions?

  • Record, evaluate and implement as appropriate, and monitor the implementation
500
  • What should a quality manual include? (name all 5) 
  • Quality policy, scope of the QMS, organization and management structure, description of roles of lab management, structure and relationship of documentations, documented policies of the QMS (4.2.2.2)
500

Give at least three examples where the laboratory shall validate examination procedures:

1. non-standard methods 

2. laboratory designated or developed methods

3. standard method used outside the intended scope

4. validated methods subsequently modified

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