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63 Cards in this Set

  • Front
  • Back

A degree to which anset of inherent characteristics fulfills requirements (ISO 9001:2008)

Quality

Part of quality management focused on fulfilling quality requirements (ISO 9000:2000)

Quality control

System of assuring the quality of total laboratory performance

Quality control

The intent of Q.C. Is to foster the production of accurate, precise and timely information

Quality control

12 essential elements of laboratory QMS


QPEPPIDOAPCF



1. Organization


2. Personnel


3. Equipment


4. Purchasing and inventory


5. Process control


6. Information management


7. Documents and records


8. Occurrence management


9. Assessment


10. Process information


11. Customer service


12. Facilities and safety



Part of quality management focused on providing confidence that the quality requirements will be fulfilled

Quality assurance

Part of quality management focused on providing confidence that the quality requirements will be fulfilled

Quality assurance

Quality management in medical laboratories

ISO 15189

Part of quality management focused on providing confidence that the quality requirements will be fulfilled

Quality assurance

Quality management in medical laboratories

ISO 15189

Requirements fornquality



General requirements of competence

ISO 17025

Part of quality management focused on providing confidence that the quality requirements will be fulfilled

Quality assurance

Quality management in medical laboratories

ISO 15189

Requirements fornquality



General requirements of competence

ISO 17025

ISO 17025 when

2005

Part of quality management focused on providing confidence that the quality requirements will be fulfilled

Quality assurance

Quality management in medical laboratories

ISO 15189

Requirements fornquality



General requirements of competence

ISO 17025

ISO 17025 when

2005

Quality assurance program (flow)

1. Quality planning (criteria and benchmark)


2. Quality lab process (inspection and accreditation)


3. Quality control


4. Quality assessment (Quality indicators)


5. Quality improvement

Part of quality management focused on providing confidence that the quality requirements will be fulfilled

Quality assurance

Quality management in medical laboratories

ISO 15189

Requirements fornquality



General requirements of competence

ISO 17025

ISO 17025 when

2005

Quality assurance program (flow)

1. Quality planning (criteria and benchmark)


2. Quality lab process (inspection and accreditation)


3. Quality control


4. Quality assessment (Quality indicators)


5. Quality improvement

QC VS QA

Quality C is more applicable to identifying when an error has occured, whereas Q.A. is more applicable to preventing an error from occurring

Part of quality management focused on providing confidence that the quality requirements will be fulfilled

Quality assurance

Quality management in medical laboratories

ISO 15189

Requirements fornquality



General requirements of competence

ISO 17025

ISO 17025 when

2005

Quality assurance program (flow)

1. Quality planning (criteria and benchmark)


2. Quality lab process (inspection and accreditation)


3. Quality control


4. Quality assessment (Quality indicators)


5. Quality improvement

QC VS QA

Quality C is more applicable to identifying when an error has occured, whereas Q.A. is more applicable to preventing an error from occurring

Areas of quality control

1. Patients, lab, personnel, lab equipment, Laboratory tests


2. Laboratory’s relation

Part of quality management focused on providing confidence that the quality requirements will be fulfilled

Quality assurance

Quality management in medical laboratories

ISO 15189

Requirements fornquality



General requirements of competence

ISO 17025

ISO 17025 when

2005

Quality assurance program (flow)

1. Quality planning (criteria and benchmark)


2. Quality lab process (inspection and accreditation)


3. Quality control


4. Quality assessment (Quality indicators)


5. Quality improvement

QC VS QA

Quality C is more applicable to identifying when an error has occured, whereas Q.A. is more applicable to preventing an error from occurring

Areas of quality control

1. Patients, lab, personnel, lab equipment, Laboratory tests


2. Laboratory’s relation

System concepts of QUALITY CONTROL

1. Quality surveillance system


2. Q.C. Corrective system


3. Objective Q.C. parameters

Part of quality management focused on providing confidence that the quality requirements will be fulfilled

Quality assurance

Quality management in medical laboratories

ISO 15189

Requirements fornquality



General requirements of competence

ISO 17025

ISO 17025 when

2005

Quality assurance program (flow)

1. Quality planning (criteria and benchmark)


2. Quality lab process (inspection and accreditation)


3. Quality control


4. Quality assessment (Quality indicators)


5. Quality improvement

QC VS QA

Quality C is more applicable to identifying when an error has occured, whereas Q.A. is more applicable to preventing an error from occurring

Areas of quality control

1. Patients, lab, personnel, lab equipment, Laboratory tests


2. Laboratory’s relation

System concepts of QUALITY CONTROL

1. Quality surveillance system


2. Q.C. Corrective system


3. Objective Q.C. parameters

Procedures in QAP

Control of pre analytical variables

Control of pre analytical variables factors

1. Patient identification


2. Proper preparation


3.

Part of quality management focused on providing confidence that the quality requirements will be fulfilled

Quality assurance

Main factors of

Choice of analytical methodology


Proper document of analytical variables


Proper handling

Quality management in medical laboratories

ISO 15189

Requirements fornquality



General requirements of competence

ISO 17025

ISO 17025 when

2005

Quality assurance program (flow)

1. Quality planning (criteria and benchmark)


2. Quality lab process (inspection and accreditation)


3. Quality control


4. Quality assessment (Quality indicators)


5. Quality improvement

QC VS QA

Quality C is more applicable to identifying when an error has occured, whereas Q.A. is more applicable to preventing an error from occurring

Areas of quality control

1. Patients, lab, personnel, lab equipment, Laboratory tests


2. Laboratory’s relation

System concepts of QUALITY CONTROL

1. Quality surveillance system


2. Q.C. Corrective system


3. Objective Q.C. parameters

Procedures in QAP

Control of pre analytical variables

Control of pre analytical variables factors

1. Patient identification


2. Proper preparation


3.

Control of post analytical variables factors

1. Verification of calculation if the finalnresults


2.


3.


4. Timeless