ISO/IEC 17025:2017 Clause 4.2 Confidentiality

 

Confidentiality is an essential aspect of laboratory work, and its importance cannot be overstated. This is because laboratories are often entrusted with technical and non-technical information from consumers, such as specifications, procedures, methods, contract documentation, and other materials that must remain confidential. It is the responsibility of the laboratory to protect this information and ensure that it is accessible only to authorized personnel.

In the laboratory, confidentiality refers to the safeguarding of information to ensure that it is not made available or discussed with unauthorized individuals, entities, or processes. This is necessary because customers expect that the information they provide to the laboratory will remain confidential and not be shared with their competitors. The consequences of a breach of confidentiality in the laboratory can be severe, as it can lead to loss of business, legal liabilities, and damage to the laboratory's reputation.

The ISO 17025:2017 standard places a strong emphasis on confidentiality and requires laboratories to be responsible for the management of all information obtained or created during the performance of laboratory activities through legally enforceable commitments. This means laboratories must have policies and procedures to protect their customer’s confidential information. The standard also requires that laboratories inform customers in advance if any additional information will be made publicly available.

Laboratories may receive information from various sources other than the customer, such as complainants or regulators. Even if information is obtained from these sources, it is the laboratory's responsibility to keep this information confidential and not disclose it to anyone unless required by law. If the release of confidential information is prohibited by law or required by law to release information to an authority having jurisdiction, the laboratory must comply with the appropriate laws.

To ensure confidentiality, the laboratory should ensure that information and data are accessible only to authorized personnel and not made available to unauthorized individuals. This includes personnel such as committee members, contractors, personnel of external bodies, or individuals acting on the laboratory's behalf, who should keep confidential all information obtained or created during the performance of laboratory activities.

Implementing impartiality is also important in maintaining confidentiality. Impartiality refers to the ability of the laboratory to carry out its activities without bias or influence from internal or external sources. Impartiality helps to ensure that the laboratory does not disclose confidential information to any unauthorized parties. Training on the confidentiality policies of the organization should be given to the management and employees. Confidentiality training should be part of new employee orientation and completed within a reasonable time after personnel begins work within the laboratory. The laboratory's policies should be communicated to all laboratory personnel through regular staff meetings and at the annual management review. Formal confidentiality non-disclosure agreements may need to be signed and recorded by all personnel before accessing confidential information or data.

The laboratory should have controlled policies in place to ensure the protection of its customers' confidential information. This includes procedures for protecting the electronic storage and transmission of data. The laboratory should also have strict controls on who can access confidential information and how it is handled. This may include physical security measures such as locked cabinets or secure rooms for storing confidential information. The laboratory should have a well-designed and implemented information security system that includes monitoring, recording, and access control mechanisms.

Laboratories must ensure that they have policies and procedures in place to protect their customer's confidential information. Laboratory personnel must be trained on these policies and procedures and be aware of the importance of maintaining confidentiality. Strict controls must also be in place to ensure that confidential information is not accessed or disclosed to unauthorized individuals or entities. The laboratory must also have in place an incident management system that can respond effectively to any security breaches.

Overall, confidentiality is a crucial aspect of laboratory work, and laboratories must take steps to protect their client's confidential information. This includes having policies and procedures in place to protect the electronic storage and transmission of data.

Protection of information “Confidentiality”

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