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quality_manual [2026/03/05 07:50] qm_lssth [7.4 Post-examination processes] |
quality_manual [2026/03/14 16:34] (current) qm_lssth |
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| =====Amendment Log===== | =====Amendment Log===== | ||
| ^Sr. No^ Date of Amendment^ Page & Clause Number of Amendment^ Amendment detail^ Reason for Amendment^ | ^Sr. No^ Date of Amendment^ Page & Clause Number of Amendment^ Amendment detail^ Reason for Amendment^ | ||
| - | |1 | | | + | |1 |05/03/2026 |7.2.6.2| Clause number 7.2.6.2 contain documentary procedure instead of policy in QM, policy is added according to the ISO 15189: |
| Line 550: | Line 550: | ||
| - Determining the competence requirements | - Determining the competence requirements | ||
| - [[Position descriptions]] | - [[Position descriptions]] | ||
| - | - Training and re-training; | + | - [[https:// |
| - [[https:// | - [[https:// | ||
| - Monitoring competence of personnel. | - Monitoring competence of personnel. | ||
| 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 | + | 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' |
| 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 777: | Line 777: | ||
| ===7.2.3.1 General=== | ===7.2.3.1 General=== | ||
| - | 1. Each request accepted by the laboratory for examination(s) will be considered an agreement{{ :: | + | 1. Each request accepted by the laboratory for examination(s) will be considered an [[consent|agreement.]] |
| 2. The examination request will provide sufficient information to ensure: | 2. The examination request will provide sufficient information to ensure: | ||
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| The laboratory will have [[https:// | The laboratory will have [[https:// | ||
| - | 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. |
| ===7.2.4.2 Information for pre-collection activities=== | ===7.2.4.2 Information for pre-collection activities=== | ||
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| ===7.2.4.3 Patient consent=== | ===7.2.4.3 Patient consent=== | ||
| - | 1. The laboratory will obtain the informed consent of the patient for all procedures carried out on the patient.[[https:// | + | 1. The laboratory will obtain the informed |
| **NOTE:** For most routine laboratory procedures, consent can be inferred when the patient willingly submits to the sample collecting procedure, for example, venipuncture. | **NOTE:** For most routine laboratory procedures, consent can be inferred when the patient willingly submits to the sample collecting procedure, for example, venipuncture. | ||
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| - safe disposal of materials used in the collection process. | - safe disposal of materials used in the collection process. | ||
| - | ===7.2.5 Sample transportation=== | + | ===7.2.5 Sample transportation=== |
| 1. To ensure the timely and safe transportation of samples, the laboratory will provide instructions for: | 1. To ensure the timely and safe transportation of samples, the laboratory will provide instructions for: | ||
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| 2. If the integrity of a sample has been compromised and there is a health risk, the organization responsible for the transport of the sample will be notified immediately and action taken to reduce the risk and to prevent recurrence. | 2. If the integrity of a sample has been compromised and there is a health risk, the organization responsible for the transport of the sample will be notified immediately and action taken to reduce the risk and to prevent recurrence. | ||
| - | 3. The laboratory will [[establish and periodically evaluate adequacy of sample transportation systems]]. | + | 3. The laboratory will [[https:// |
| ===7.2.6 Sample receipt=== | ===7.2.6 Sample receipt=== | ||
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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:// |
| **NOTE:** In this context, " | **NOTE:** In this context, " | ||
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| 1) The laboratory will implement the procedures needed for the identification, | 1) The laboratory will implement the procedures needed for the identification, | ||
| - | 2) The retention times for records shall be specified. | + | 2) [[https:// |
| **NOTE 1:** In addition to requirements, | **NOTE 1:** In addition to requirements, | ||
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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:// |
| 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 1472: | Line 1472: | ||
| The laboratory will seek feedback from its patients, users, and personnel. The feedback will be analyzed and used to improve the management system, laboratory activities and services to users. | The laboratory will seek feedback from its patients, users, and personnel. The feedback will be analyzed and used to improve the management system, laboratory activities and services to users. | ||
| - | Records of feedback will be maintained including the actions taken. Communication will be provided to personnel on actions taken arising from their feedback. | + | [[Records of feedback will be maintained including the actions taken.]] Communication will be provided to personnel on actions taken arising from their feedback. |
| ====8.7 Nonconformities and corrective actions==== | ====8.7 Nonconformities and corrective actions==== | ||
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| ===8.8.2 Quality indicators=== | ===8.8.2 Quality indicators=== | ||
| - | The process of monitoring quality indicators will be planned, which includes establishing the objectives, methodology, | + | The process of monitoring |
| ===8.8.3 Internal audits=== | ===8.8.3 Internal audits=== | ||
| - | {{https:// | + | ===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. |
| - | 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 | ||
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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:// | The laboratory shall {{https:// | ||
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| 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:// |
| - | following: | + | following: |
| - Status of actions from previous management reviews, internal and external changes to the | - Status of actions from previous management reviews, internal and external changes to the | ||