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quality_manual [2025/09/18 10:51] – [6.2 Personnel] adminquality_manual [2025/09/19 12:58] (current) – [6.4 Equipment] admin
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 ====4.1 Impartiality==== ====4.1 Impartiality====
  
-  - Laboratory activities will be undertaken impartially. The laboratory will be structured and managed to safeguard impartiality. +  - Laboratory activities will be undertaken impartially. The laboratory will be [[structured]] and managed to safeguard impartiality. 
   - The laboratory management will be committed to impartiality.   - The laboratory management will be committed to impartiality.
   - The laboratory will be responsible for the impartiality of its laboratory activities and will not allow commercial, financial or other pressures to compromise impartiality.   - The laboratory will be responsible for the impartiality of its laboratory activities and will not allow commercial, financial or other pressures to compromise impartiality.
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 The laboratory will: The laboratory will:
-  - Define its  [[https://docs.google.com/presentation/d/1uGYuUTY2E4d8lGzvZMaVGNtlrpAZ0mCn/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|Organization chart]] and management structure, its place in any parent organization, and the relationships between management, technical operations and support services.+  - Define its  [[https://drive.google.com/file/d/1yzEeVm0r329cRyEazJ-ycOtbACPnbBqk/view?usp=drive_link|Organization chart]] and management structure, its place in any parent organization, and the relationships between management, technical operations and support services.
   - Specify the responsibility, authority, lines of communication and interrelationship of all personnel who manage, perform or verify work affecting the results of laboratory activities.   - Specify the responsibility, authority, lines of communication and interrelationship of all personnel who manage, perform or verify work affecting the results of laboratory activities.
   - Specify its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results.   - Specify its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results.
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 **NOTE:** These responsibilities can be assigned to one or more persons. **NOTE:** These responsibilities can be assigned to one or more persons.
 ====5.5 Objectives and policies==== ====5.5 Objectives and policies====
- 1) Laboratory management will establish and maintain [[https://docs.google.com/document/d/14DAC9pi9uau2wEfbNEzk5PdVk93P7ezu/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|objectives and policies]] to:+ 1) Laboratory management will establish and maintain [[objectives and policies]] to:
   * Meet the needs and requirements of its patients and users;   * Meet the needs and requirements of its patients and users;
   * Commit to good professional practice;   * Commit to good professional practice;
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 **NOTE:** Types of quality indicators include the number of unacceptable samples relative to the number received, the number of errors at either registration or sample receipt, or both, the number of corrected reports, the rate of achievement of specified turnaround times. **NOTE:** Types of quality indicators include the number of unacceptable samples relative to the number received, the number of errors at either registration or sample receipt, or both, the number of corrected reports, the rate of achievement of specified turnaround times.
 ====5.6 Risk management==== ====5.6 Risk management====
-  -  Laboratory management will establish, implement, and maintain processes for identifying risks of harm to patients and opportunities for improved patient care associated with its examinations and activities, and develop actions to address both risks and opportunities for improvement.{{https://docs.google.com/document/d/1ZuZwb7QZ5fEjFInpkhp7t3e_Uzq2Y5wE/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|Risk Management Plan}}+  -  Laboratory management will establish, implement, and maintain [[processes for identifying risks of harm to patients and opportunities for improved patient care associated with its examinations and activities, and develop actions]] to address both risks and opportunities for improvement.
   -  The laboratory director will ensure that these processes are evaluated for effectiveness and modified, when identified as being ineffective.   -  The laboratory director will ensure that these processes are evaluated for effectiveness and modified, when identified as being ineffective.
 **NOTE 1:** ISO 22367 provides details for managing risk in medical laboratories. **NOTE 1:** ISO 22367 provides details for managing risk in medical laboratories.
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 1. The laboratory will have access to a [[sufficient number of competent persons to perform]] its activities. 1. The laboratory will have access to a [[sufficient number of competent persons to perform]] its activities.
 [[https://drive.google.com/drive/folders/19KrjAjLfq32MWHLxy8_ptycV8xxpy9WY?usp=drive_link| Employee's Personal Details]] [[https://drive.google.com/drive/folders/19KrjAjLfq32MWHLxy8_ptycV8xxpy9WY?usp=drive_link| Employee's Personal Details]]
-{{https://docs.google.com/document/d/1tdi0BwK_f_YeoccT_o4KMlPy5_YxOqgI/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Format for Employee's Personal Profile}}+{{https://drive.google.com/file/d/1W_FCQwodQYiiSguh18G1f2B2o2AiFVvd/view?usp=drive_link| Format for Employee's Personal Profile}}
  
  
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 3. The laboratory will communicate to laboratory personnel the importance of meeting the needs and requirements of users as well as the requirements of this document. 3. The laboratory will communicate to laboratory personnel the importance of meeting the needs and requirements of users as well as the requirements of this document.
  
-4. The laboratory has a [[https://docs.google.com/document/d/1SivFfxPNa-fc1jBkSZmfgn2yCtXRs7pH/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true |programmed to introduce personnel to the organization]], the department or area in which the person will work, the terms and conditions of employment, staff facilities, health and safety requirements, and occupational health services.[[https://drive.google.com/drive/folders/1Cj2VwQX9fDecSeGOdPZXD8C8QmvOJhUP?usp=drive_link|Record of induction training of new staff]]+4. The laboratory has a [[https://drive.google.com/file/d/1MuRx8vTBC310uuJCob7DI0gKz7anFXoy/view?usp=drive_link|programmed to introduce personnel to the organization]], the department or area in which the person will work, the terms and conditions of employment, staff facilities, health and safety requirements, and occupational health services.[[https://drive.google.com/drive/folders/1Cj2VwQX9fDecSeGOdPZXD8C8QmvOJhUP?usp=drive_link|Record of induction training of new staff]]
  
 ===6.2.2 Competence requirements=== ===6.2.2 Competence requirements===
-  - The laboratory will [[https://docs.google.com/document/d/1P77PVOT59Ralg8IWWad4BFHl8_ZZfEZHYWJU-NM6kEs/edit?usp=drive_link | specify the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, re-training, technical knowledge, skills and experience]].+  - The laboratory will [[specify the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, re-training, technical knowledge, skills and experience]].
   - The laboratory will ensure all personnel have the competence to perform laboratory activities for which they are responsible.   - The laboratory will ensure all personnel have the competence to perform laboratory activities for which they are responsible.
   - The laboratory has a process for managing competence of its personnel, that includes requirements for frequency of competence assessment.   - The laboratory has a process for managing competence of its personnel, that includes requirements for frequency of competence assessment.
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   - assessment of problem-solving skills,   - assessment of problem-solving skills,
   - examination of specially provided samples, e.g. previously examined samples, interlaboratory comparison materials, or split samples.   - examination of specially provided samples, e.g. previously examined samples, interlaboratory comparison materials, or split samples.
-  - Objective Structured Practical Examination {{https://docs.google.com/spreadsheets/d/1vUhYixTjQ_HWxuwwJWG7HPvZuvaR62dq/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| OSPE method}}+  - [[Objective Structured Practical Examination]] 
  
 ===6.2.3 Authorization=== ===6.2.3 Authorization===
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 The facilities and environmental conditions will be suitable for the laboratory activities and will not adversely affect the validity of results, or the safety of patients, visitors, laboratory users, and personnel. This will include pre-examination related facilities and sites other than the main laboratory premises where examinations are performed, as well as POCT. The facilities and environmental conditions will be suitable for the laboratory activities and will not adversely affect the validity of results, or the safety of patients, visitors, laboratory users, and personnel. This will include pre-examination related facilities and sites other than the main laboratory premises where examinations are performed, as well as POCT.
  
-The requirements for facilities and environmental conditions necessary for the performance of the laboratory activities will be specified, monitored, and recorded. [[https://drive.google.com/drive/folders/1dYkknSDRIgd4AvK2W9kcYOcGseJzfDZe?usp=drive_link|Facility and environment control record]]+The requirements for facilities and environmental conditions necessary for the performance of the laboratory activities will be specified, monitored, and [[recorded]]. 
  
 **NOTE 1:** ISO 15190 provides details for facility and environmental conditions. **NOTE 1:** ISO 15190 provides details for facility and environmental conditions.
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 ====6.4 Equipment==== ====6.4 Equipment====
 ===6.4.1 General=== ===6.4.1 General===
-The laboratory has processes for the selection, procurement, installation, acceptance testing (including acceptability criteria), handling, transport, storage, use, maintenance, and decommissioning of equipment, in order to ensure proper functioning and to prevent contamination or deterioration.{{https://docs.google.com/document/d/1SwIUndhySsoMHdSY7CJboPwpdkIdrsnv/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Process for selection, procurement, installation, acceptance testing, handling, transport, storage, use, maintenance, and decommissioning of equipment}}+The laboratory has [[processes]] for the selection, procurement, installation, acceptance testing (including acceptability criteria), handling, transport, storage, use, maintenance, and decommissioning of equipment, in order to ensure proper functioning and to prevent contamination or deterioration.
  
 **NOTE:** Laboratory equipment includes hardware and software of instruments, measuring systems, and laboratory information systems, or any equipment that influences the results of laboratory activities, including sample transportation systems. **NOTE:** Laboratory equipment includes hardware and software of instruments, measuring systems, and laboratory information systems, or any equipment that influences the results of laboratory activities, including sample transportation systems.
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   - The laboratory has appropriate safeguards to prevent unintended adjustments of equipment that can invalidate examination results.   - The laboratory has appropriate safeguards to prevent unintended adjustments of equipment that can invalidate examination results.
   - Equipment will be operated by trained, authorized, and competent personnel.   - Equipment will be operated by trained, authorized, and competent personnel.
-  - Instructions for the use of equipment, including those provided by the manufacturer, will be readily available.+  - [[Instructions for the use of equipment]], including those provided by the manufacturer, will be readily available.
   - The equipment will be used as specified by the manufacturer, unless validated by the laboratory.   - The equipment will be used as specified by the manufacturer, unless validated by the laboratory.
  
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 activities. activities.
 These records will include the following, where relevant: These records will include the following, where relevant:
-  - Manufacturer and supplier details, and sufficient information to uniquely identify each item of equipment, including software and firmware; {{https://docs.google.com/spreadsheets/d/1oB5mclXPP51h9UBgn5UF62Vlgf-lnpHm/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true| Equipment stock register}} +  - [[Manufacturer and supplier details, and sufficient information to uniquely identify each item of equipment]], including software and firmware; 
   - Dates of receipt, acceptance testing and entering into service;   - Dates of receipt, acceptance testing and entering into service;
-  - Evidence that equipment conforms with specified acceptability criteria;+  - [[Evidence that equipment conforms with specified acceptability criteria]];
   - The current location;   - The current location;
   - Condition when received (e.g. new, used or reconditioned);   - Condition when received (e.g. new, used or reconditioned);
-  - Manufacturer's instructions;{{https://drive.google.com/drive/folders/1Kli-zUH8Q1U9tx12SvjK9Q_K-BJGzlkw?usp=drive_link| Equipment Instructions for Use}} +  - [[Manufacturer's instructions]]; 
-  - The programme for preventive maintenance;  +  - [[The programme for preventive maintenance]];  
-  - Any maintenance activities performed by the laboratory or approved external service provider; +  - [[Any maintenance activities performed by the laboratory or approved external service provider]]; 
-  - [[https://docs.google.com/spreadsheets/d/1MD7oBCGUHddNwI4JI_oA6PIdDFEdV2RS/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|Damage to, malfunction, modification, or repair of the equipment]] +  - [[Damage to, malfunction, modification, or repair of the equipment]] 
-  - Equipment performance records such as reports or certificates of calibrations or verifications, or both, including dates, times and results; {{https://drive.google.com/drive/folders/1vVDKrKE2kPw435ryPcaAwZuCg78CjyZ5?usp=drive_link| Equipment Calibration Certificate & raw data}} +  - Equipment performance records such as reports or [[certificates of calibrations or verifications]], or both, including dates, times and results; 
   - status of the equipment such as active or in-service, out-of-service, quarantined, retired or obsolete.   - status of the equipment such as active or in-service, out-of-service, quarantined, retired or obsolete.
  
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 **NOTE:** Examples of qualitative methods and quantitative methods that may not allow metrological traceability include red cell antibody detection, antibiotic sensitivity assessment, genetic testing, erythrocyte sedimentation rate, flow cytometry marker staining, and tumor HER2 immunohistochemical staining. **NOTE:** Examples of qualitative methods and quantitative methods that may not allow metrological traceability include red cell antibody detection, antibiotic sensitivity assessment, genetic testing, erythrocyte sedimentation rate, flow cytometry marker staining, and tumor HER2 immunohistochemical staining.
 ===6.5.2 Equipment calibration=== ===6.5.2 Equipment calibration===
-The laboratory will have procedures for the calibration of equipment that directly or indirectly affects  +The laboratory will have [[procedures for the calibration of equipment]] that directly or indirectly affects  
-examination results. {{ https://docs.google.com/document/d/1UX0PwfoxIp0lnRjXoVOil-hp_KWRO5gUWOOBzs6IW8s/edit?usp=drive_link | Documentary Procedures for the calibration of equipment }} +examination results. 
 The procedures will specify: The procedures will specify:
   -  Conditions of use and manufacturer's instructions for calibration;   -  Conditions of use and manufacturer's instructions for calibration;
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 ====6.6 Reagents and consumables==== ====6.6 Reagents and consumables====
 ===6.6.1 General=== ===6.6.1 General===
-The laboratory will have processes for the selection, procurement, reception, storage, acceptance testing and inventory management of reagents and consumables.{{https://docs.google.com/document/d/1C_Arq2sbMklhV_NiBq7V_OI308_Nr7zGYiK2_472BuY/edit?usp=drive_link|Process for the Selection, Procurement, Reception, Storage, Acceptance testing and Inventory management of reagents and consumables}}+The laboratory will have [[processes for the selection, procurement, reception, storage, acceptance testing and inventory management of reagents and consumables]].
  
 **NOTE:** Reagents include substances which are commercially supplied or prepared in-house, reference materials (calibrators and QC materials), culture media; consumables include pipette tips, glass slides, POCT supplies etc. **NOTE:** Reagents include substances which are commercially supplied or prepared in-house, reference materials (calibrators and QC materials), culture media; consumables include pipette tips, glass slides, POCT supplies etc.