quality_manual

Differences

This shows you the differences between two versions of the page.

Link to this comparison view

Both sides previous revision Previous revision
Next revision 		Previous revision
quality_manual [2026/03/05 11:39]
qm_lssth [8.9 Management reviews] 		quality_manual [2026/03/14 16:34] (current)
qm_lssth
Line 763: Line 763:
  
 ===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;
Line 1235: Line 1235:
  
 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====
  
Line 1381: Line 1381:
 ===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.
Line 1413: Line 1413:
 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.
Line 1464: Line 1464:
 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.
Line 1525: Line 1525:
 ===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.
  
-a) conforms to the laboratory’s own requirements for its management system, including the  +a) conforms to the laboratory’s own requirements for its management system, including the laboratory activities,
-laboratory activities,+
  
 b) conforms to the requirements of this document, and b) conforms to the requirements of this document, and
Line 1536: Line 1535:
 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:
Line 1568: Line 1567:
 to the fulfilment of this document. to the fulfilment of this document.
 ===8.9.2 Review input=== ===8.9.2 Review input===
-The [[inputs to management review shall be recorded]] and shall include evaluations of at least the +The [[https://drive.google.com/drive/folders/1GbhXKuRUQrX9BisOl8aMFmjv5gUe0m5x?usp=drive_link|inputs to management review shall be recorded]] and shall include evaluations of at least the 
 following: following:
  
  • quality_manual.1772710783.txt.gz
  • Last modified: 2026/03/05 11:39
  • by qm_lssth