Table 2.
List and description of procedures of the Quality Assurance Manual.
| Number | Title | Scope and Application |
|---|---|---|
| P1 | Protection of confidential information | The laboratory guarantees the confidentiality of customer data |
| P2 | Management of documentation of Quality Assurance System | The external or internal documents are identified, registered, and listed in a specific archive |
| P3 | Definition of the contract | The customers accept and sign the proposal of the contract with the Laboratory |
| P4 | Selection of suppliers | The Laboratory selects a specific list for qualified suppliers of reagents, instruments, and equipment and periodically updates it |
| P5 | Check of reagents and equipment | The Laboratory verifies the correct status of equipment and expiry date and the suitability for use of reagents (e.g., pepsine) for the analysis |
| P6 | Resolution of customers’ complaints | The customers’ complaints are registered in a database and analyzed in order to be solved by corrective actions |
| P7 | Management of non-compliance | If the Laboratory verifies a non-compliance, it prepares a document named “Risk Assessment” with corrective actions to be applied |
| P8 | Management of corrective and preventive actions | The Laboratory evaluates the cause of non-compliance and implements corrective/preventive actions in order to avoid the recurring of such event |
| P9 | Management of audit | The audits are conducted annually aiming at verifying if the Quality Assurance System is compliant with ISO/IEC 17025:2005 |
| P10 | Revision by General Direction | The General Direction makes an annual revision of the Quality Assurance System generally after the visit by ACCREDIA |
| P11 | Training of personnel | The Technical Direction guarantees the training of personnel and confirms its effectiveness |
| P12 | Monitoring and maintenance of environmental conditions | The procedures of sanitation are applied daily after the analysis and more accurately each month |
| P13 | Validation of analysis | The validation involves only the good practice of both equipment and technician because the applied method is already officially recognized |
| P14 | Control of data | The Technical Direction examines and signs the test report |
| P15 | Management of equipment | The Laboratory tests the equipment before the analysis in order to check its suitability |
| P16 | Management and setting of instruments | The Laboratory performs the setting of instruments when required |
| P17 | Sampling | The sampling is carried out by qualified personnel under the supervision of the competent authority |
| P18 | Handling and storage of sample | The Laboratory controls the integrity, temperature, and quantity of samples at their arrival |
| P19 | Quality Assurance | The Laboratory assures the quality of the analysis by using spiked meatballs as a reference certified material and participating in inter-laboratory tests |