ISO/IEC 17025:2017 Clause 5.6 to 5.7 - Structural requirements

 Clause 5.6

The laboratory require scientific and technical support to ensure the quality and reliability of products and services. The laboratory management system is designed to ensure that laboratory activities are performed in a controlled and consistent manner. This requires laboratory personnel who have the necessary authority and resources to carry out their duties.The laboratory personnel have several critical responsibilities that support the laboratory management system.

(a)    They must implement, maintain and improve the management system to ensure that the laboratory complies with relevant standards and regulations. This includes developing and maintaining policies, procedures, and guidelines to guide laboratory activities.

(b)   The laboratory personnel must ensure that laboratory activities are conducted in accordance with established procedures and guidelines. They must follow standardized protocols when performing tests, handling samples, and using laboratory equipment. This helps to ensure that laboratory activities are consistent and reliable.

(c)    The laboratory personnel must identify any deviations from the management system or the procedures for performing laboratory activities. Deviations can occur for various reasons, including errors in testing, equipment malfunctions, or human error. It is the responsibility of laboratory personnel to identify these deviations promptly and take appropriate actions to prevent or minimize them.

(d)   The laboratory personnel must report on the performance of the management system and any need for improvement. This reporting may include the results of internal audits, customer complaints, or any other relevant information that may impact laboratory operations. Reporting is critical to ensure that laboratory management is aware of any issues that may affect laboratory operations and can take appropriate corrective action.

(e)    The laboratory personnel must ensure the effectiveness of laboratory activities. This requires ongoing monitoring, measurement, and analysis of laboratory activities to ensure that they meet established quality standards. Laboratory personnel must perform regular checks on equipment and instruments to ensure that they are calibrated correctly and operate reliably. They must also monitor the quality of results produced by laboratory activities to ensure that they meet the necessary quality requirements.

The laboratory personnel play a critical role in ensuring the effectiveness and reliability of laboratory activities. They must implement, maintain and improve the laboratory management system, identify deviations and initiate actions to prevent or minimize them, report on the performance of the management system, and ensure the effectiveness of laboratory activities. By fulfilling these responsibilities, laboratory personnel can help ensure that laboratory activities are conducted in a controlled and consistent manner and produce reliable results that meet the necessary quality requirements. This, in turn, helps to ensure the quality and reliability of the products and services that rely on laboratory testing and support.

 

Clause 5.7

Laboratory management plays a critical role in ensuring that laboratory activities are conducted in a controlled and consistent manner, and the laboratory management system is effective in meeting the requirements of customers and other stakeholders. To achieve this, the laboratory management must ensure that communication takes place regarding the effectiveness of the management system and the importance of meeting customers' and other requirements. Additionally, the laboratory management must ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented.

a)      Communication is an essential aspect of laboratory management to ensure that all stakeholders understand the laboratory's operations, policies, and procedures. Laboratory management must ensure that communication takes place regarding the effectiveness of the management system and the importance of meeting customers' and other requirements. This includes communicating with laboratory personnel, customers, regulatory bodies, and other stakeholders.Effective communication can help to promote a culture of quality and ensure that laboratory personnel understand the importance of following established procedures and guidelines. Communication can also help to identify areas for improvement and encourage feedback from stakeholders, which can help to improve laboratory operations and performance.

b)      The laboratory management must also ensure that the integrity of the management system is maintained when changes to the management system are planned and implemented. Changes to the management system may be necessary to improve laboratory operations, meet regulatory requirements, or address issues identified through internal or external audits. However, it is crucial to ensure that changes to the management system do not compromise the effectiveness of the laboratory management system.

Maintaining the integrity of the management system requires careful planning and implementation of changes. Laboratory management must ensure that changes are documented, reviewed, and approved before implementation. This includes assessing the impact of changes on laboratory operations, identifying any risks associated with the changes, and ensuring that appropriate controls are in place to mitigate those risks.

Additionally, laboratory management must ensure that personnel are trained on the changes to the management system and understand their roles and responsibilities related to the changes. This can help to ensure that changes are implemented effectively and that the integrity of the management system is maintained.

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