Paragraph 4.2 of ISO/IEC 17025:2017 examines confidentiality requirements. The laboratory is responsible for the management of all information received or produced during laboratory activities and is held responsible by the application of prosecution law. The standard requires the laboratory to inform its customers in advance of the information it intends to share with the public. It is also looking at what action it will take when confidential information is made public. Confidential also asks for laboratory staff. As a general rule, the laboratory and its staff are responsible for the information obtained or produced during the execution of laboratory activities and all information is considered protected and considered confidential, except as required by law. The definition of ISO/IEC 17025 2017 is “presence of objectivity” and is specified in a note that states that “objectivity means that conflicts of interest do not exist or are resolved so as not to compromise the laboratory`s subsequent activities.” In many countries, there are laws that protect the confidentiality of certain workplace information. The calibration industry has specific rules and rules for the handling of confidential information, as defined in various international standards. ISO/IEC 17025:2017, which regulates the accreditation of calibration laboratories, stipulates that the laboratory must “keep confidential all information obtained or produced during the performance of laboratory activities, unless required by law.” MOTIVA publishes a series of information videos on laboratory accreditation. As each is developed, it is added to the list displayed on this page.
The videos are in .mp4 format. They are an excellent starting point for learning more about accreditation and the preparation and implementation of an ISO/CIS 17025 compliant laboratory quality system. Because each wehapsator gives someone the learning they need, they can go back to that page and download the necessary documents and forms. Formal Confidentiality or Confidentiality Agreements (NOAs) may need to be signed and obtained by all staff members before they have access to confidential information. These agreements are now necessary for most companies, as employees are able to transmit large amounts of data simply electronically. Most confidentiality agreements remain in place indefinitely and can protect the laboratory long after leaving the lab. Laboratory staff, suppliers, external staff, etc., should also sign a confidentiality statement. ISO standards define confidentiality as “information protection to ensure that data is only accessible to authorized employees and is not made available or disclosed to unauthorized individuals, businesses or processes.” Click here for the full ISO/IEC 17025:2017 and simplify the ISO/IEC 17025 2017 implementation.
Impartiality is an important clause in ISO/CIS 17025. This clause addresses the risks associated with the development of biased results. Under no circumstances should the laboratory affect conflicts of interest on its results and the laboratory must engage in a risk-based approach when dealing with impartiality. Essentially, there should be no conflict of interest in training laboratory management and staff in laboratory privacy policies and procedures.