quality_manual

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quality_manual [2026/03/05 11:54]
qm_lssth [8.8 Evaluations] 		quality_manual [2026/03/14 16:34] (current)
qm_lssth
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 ===7.2.2 Laboratory information for patients and users=== ===7.2.2 Laboratory information for patients and users===
-The laboratory will have appropriate information available for its users and patients {{ |DOS}}. The information will be sufficiently detailed to provide laboratory users with a comprehensive understanding of the laboratory's scope of activities and requirements.+The laboratory will have appropriate information available for its users and patients. The information will be sufficiently detailed to provide laboratory users with a comprehensive understanding of the laboratory's scope of activities and requirements.
 The information will include as appropriate: The information will include as appropriate:
   - The location(s) of the laboratory, operating hours and contact information;   - The location(s) of the laboratory, operating hours and contact information;
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 The laboratory will implement corrective action commensurate with the risk of recurrence of the  The laboratory will implement corrective action commensurate with the risk of recurrence of the 
-nonconforming work.The laboratory will retain records of nonconforming work and actions.+nonconforming work.The laboratory will [[retain records]] of nonconforming work and actions.
 ====7.6 Control of data and information management==== ====7.6 Control of data and information management====
  
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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 document.+The laboratory will [[https://drive.google.com/drive/folders/14iFewKpTLxkglLWuWEPquIk_nw_WsIFH?usp=drive_link|control the documents]] (internal and external) that relate to the fulfilment of this 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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 1) The laboratory will implement the procedures needed for the identification, storage, protection from unauthorized access and changes, back-up, archive, retrieval, retention time, and disposal of its records. 1) The laboratory will implement the procedures needed for the identification, storage, protection from unauthorized access and changes, back-up, archive, retrieval, retention time, and disposal of its records.
  
-2) The retention times for records shall be specified.+2) [[https://docs.google.com/document/d/1u1QZ2leKo9Q6nyI8XfAUNdCgv0Xw_DV8/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true|The retention times for records shall be specified.]]
  
 **NOTE 1:** In addition to requirements, retention times can be chosen based on identified risks. **NOTE 1:** In addition to requirements, retention times can be chosen based on identified risks.
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 3) The laboratory will evaluate the effectiveness of the actions taken. 3) The laboratory will evaluate the effectiveness of the actions taken.
  
-4) Laboratory management will ensure that the laboratory participates in continual improvement activities that encompass relevant areas and outcomes of patient care.+4) [[https://drive.google.com/drive/folders/1e-2jKfxfeVS-GEJsC8Ad7lN8ScYBzNBp?usp=drive_link|Laboratory management will ensure that the laboratory participates in continual improvement activities that encompass relevant areas and outcomes of patient care.]]
  
 5) Laboratory management will communicate to personnel its improvement plans and related goals. 5) Laboratory management will communicate to personnel its improvement plans and related goals.
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 ===8.8.3 Internal audits=== ===8.8.3 Internal audits===
  
-{{https://docs.google.com/document/d/1jejprweDq7ZIIR5g-UNMVgxZYPIE1shpIx5UI8w8GOs/edit?usp=drive_link|Documentary procedure for internal audit }} +===8.8.3.1=== 
- +
-==8.8.3.1== +
  
 The laboratory will conduct internal audits at planned intervals to provide information on whether the management system. The laboratory will conduct internal audits at planned intervals to provide information on whether the management system.
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 c) is effectively implemented and maintained. c) is effectively implemented and maintained.
  
-==8.8.3.2==+===8.8.3.2===
  
 The laboratory shall {{https://drive.google.com/drive/folders/1WHJfreHDkxbOzC4tfi1nI0vkuqm4WGZp?usp=drive_link|plan, establish, implement and maintain an internal audit programme}} that includes: The laboratory shall {{https://drive.google.com/drive/folders/1WHJfreHDkxbOzC4tfi1nI0vkuqm4WGZp?usp=drive_link|plan, establish, implement and maintain an internal audit programme}} that includes:
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