quality_manual

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quality_manual [2025/09/23 11:05]
admin [7.2 Pre-examination processes] 		quality_manual [2025/09/27 03:43] (current)
admin [8.4 Control of records]
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 ===7.2.4.1 General=== ===7.2.4.1 General===
  
-The laboratory will have [[procedures for the collection and handling of primary samples]].  +The laboratory will have [[https://docs.google.com/document/d/1ZvRrc8Fo4bKoN9ycP0Jrw0g9ogXjTZNyhBwa0R54emA/edit?usp=drive_link|procedures for the collection and handling of primary samples]].  
 Information will be available to those responsible for sample collection. Any deviation from the established collection procedures will be clearly recorded. The potential risk and impact on the patient outcome of acceptance or rejection of the sample will be assessed, recorded and shall be communicated to the appropriate personnel. The laboratory will periodically review requirements for sample volume, collection device and preservatives for all sample types, as applicable, to ensure that neither insufficient nor excessive amounts of sample are collected, and samples are properly collected to preserve the analyte. Information will be available to those responsible for sample collection. Any deviation from the established collection procedures will be clearly recorded. The potential risk and impact on the patient outcome of acceptance or rejection of the sample will be assessed, recorded and shall be communicated to the appropriate personnel. The laboratory will periodically review requirements for sample volume, collection device and preservatives for all sample types, as applicable, to ensure that neither insufficient nor excessive amounts of sample are collected, and samples are properly collected to preserve the analyte.
  
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 ===8.2.1 General=== ===8.2.1 General===
  
-Laboratory management will establish, document, and maintain objectives and policies for the fulfilment of the purposes of this document and will ensure that the objectives and policies are acknowledged and implemented at all levels of the laboratory organization. +Laboratory management will establish document, and maintain objectives and policies for the fulfilment of the purposes of this document and will ensure that the objectives and policies are acknowledged and implemented at all levels of the laboratory organization.
-{{|--------QM pdf}}+
  
 **NOTE:** The management system documents can, but are not required to, be contained in a quality manual. **NOTE:** The management system documents can, but are not required to, be contained in a quality manual.
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 ===8.3.1 General=== ===8.3.1 General===
  
-The laboratory will control the documents (internal and external) that relate to the fulfilment of this  +The laboratory will control the documents (internal and external) that relate to the fulfilment of this document.
-document.+
  
 **NOTE:** In this context, "document" can be policy statements, procedures and related job aids, flow charts, instructions for use, specifications, manufacturer's instructions, calibration tables, biological reference intervals and their origins, charts, posters, notices, memoranda, software documentation, drawings, plans, agreements, and documents of external origin such as laws, regulations, standards and textbooks from which examination methods are taken, documents describing personnel qualifications (such as job descriptions), etc. These can be in any form or type of medium, such as hard copy or digital. **NOTE:** In this context, "document" can be policy statements, procedures and related job aids, flow charts, instructions for use, specifications, manufacturer's instructions, calibration tables, biological reference intervals and their origins, charts, posters, notices, memoranda, software documentation, drawings, plans, agreements, and documents of external origin such as laws, regulations, standards and textbooks from which examination methods are taken, documents describing personnel qualifications (such as job descriptions), etc. These can be in any form or type of medium, such as hard copy or digital.
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 ===8.3.2 Control of documents=== ===8.3.2 Control of documents===
 The laboratory will ensure that: The laboratory will ensure that:
-{{ https://docs.google.com/spreadsheets/d/1FgPYEGFZ7v3LObAUIYsLXDp8zg1cFdjT/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true | Master list of documents }} 
- {{ https://docs.google.com/document/d/10j2wNoTWdooTE-QhwIaZTn3Jg5YG5uv_/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true | Documentary Procedure for Control of Documents }} 
   - Documents are uniquely identified;   - Documents are uniquely identified;
   - Documents are approved for adequacy before issue by authorized personnel who have the expertise and competence to determine adequacy;   - Documents are approved for adequacy before issue by authorized personnel who have the expertise and competence to determine adequacy;
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 ====8.4 Control of records====  ====8.4 Control of records==== 
- 
-{{ https://docs.google.com/document/d/172kNPn_W_NldSaDGKfGr9sT5TAv3LOqw/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true | Documentary Procedure for Control of Records 
-}} 
  
 ===8.4.1 Creation of records=== ===8.4.1 Creation of records===
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