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| quality_manual [2025/09/19 04:10] – [6.6 Reagents and consumables] admin | quality_manual [2025/09/19 12:58] (current) – [6.4 Equipment] admin | ||
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| Line 482: | Line 482: | ||
| The laboratory will: | The laboratory will: | ||
| - | - Define its [[https://docs.google.com/ | + | - Define its [[https://drive.google.com/ |
| - Specify the responsibility, | - Specify the responsibility, | ||
| - 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. | ||
| Line 494: | Line 494: | ||
| **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:// | + | 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; | ||
| Line 506: | Line 506: | ||
| **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:// | + | - Laboratory management will establish, implement, and maintain |
| - 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. | ||
| Line 519: | Line 519: | ||
| 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:// | [[https:// | ||
| - | {{https://docs.google.com/ | + | {{https://drive.google.com/ |
| Line 528: | Line 528: | ||
| 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/ | + | 4. The laboratory has a [[https://drive.google.com/ |
| ===6.2.2 Competence requirements=== | ===6.2.2 Competence requirements=== | ||
| Line 542: | Line 542: | ||
| - 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 | + | - [[Objective Structured Practical Examination]] |
| ===6.2.3 Authorization=== | ===6.2.3 Authorization=== | ||
| Line 597: | Line 597: | ||
| ====6.4 Equipment==== | ====6.4 Equipment==== | ||
| ===6.4.1 General=== | ===6.4.1 General=== | ||
| - | The laboratory has [[processes for the selection, procurement, | + | The laboratory has [[processes]] for the selection, procurement, |
| **NOTE:** Laboratory equipment includes hardware and software of instruments, | **NOTE:** Laboratory equipment includes hardware and software of instruments, | ||
| Line 621: | Line 621: | ||
| - 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, | + | - [[Instructions for the use of equipment]], including those provided by the manufacturer, |
| - The equipment will be used as specified by the manufacturer, | - The equipment will be used as specified by the manufacturer, | ||