ISO/IEC 17025:2017 Clause 5.4 to 5.5 - Structural requirements

 Clause 5.4  requires labs to follow ISO 17025 standards, as well as meet the requirements of  regulatory authorities, and accreditation bodies.  In addition to meeting the standards, labs must also make sure their work meets their customers' needs.

For example, let's consider a food testing laboratory that tests food products for various food manufacturers. The laboratory must follow the requirements of ISO 17025 standard i.e latest methods, equipment calibration, quality control measures etc. to ensure the accuracy and reliability of their test results. In addition to following ISO 17025 standards, a food testing laboratory must also pay attention to its customer's specific needs. To meet their customer's needs, a laboratory must work closely with them to understand their specific requirements. This involves communicating with customers to find out what they need, and then making sure that the laboratory's tests and procedures are available to meet those specific requirements. For example, a food manufacturer may need the laboratory to test for certain contaminants like pesticides, heavy metals, or allergens. The laboratory must make sure that its testing procedures can accurately detect/quantify these contaminants. To ensure this, the laboratory should have a valid accreditation scope for testing  and must use the latest testing methods.

The requirement of ISO 17025 standard applies to all laboratory activities, no matter where they take place. This includes activities carried out at the laboratory's permanent facilities, at sites away from those facilities, in temporary or mobile facilities, or even at a customer's location.

Additionally, the laboratory must comply with the requirements of regulatory authorities, and accreditation bodies to maintain its accreditation status. For example, the laboratory is  required to participate in proficiency testing programs or undergo regular audits to ensure that its laboratory meets the standards set forth by ISO 17025.

Clause 5.5 (a) requires laboratories to define their organization and management structure. This includes identifying the laboratory's place within any parent organization and outlining the relationships between different aspects of the laboratory's operations. Specifically, the laboratory must define the relationships between management, technical operations, and support services.

To meet this requirement, a laboratory must create a clear and concise organizational chart that shows the reporting structure for all personnel within the laboratory. This chart should outline the roles and responsibilities of management, technical personnel, and support staff. Additionally, it should show how the laboratory fits within any larger parent organization, if applicable.

By having a well-defined organizational and management structure, a laboratory can ensure that everyone within the organization understands their roles and responsibilities. This can help to improve efficiency and effectiveness, reduce the risk of errors or misunderstandings, and ultimately contribute to the laboratory's ability to provide accurate and reliable results.

 Clause 5.5 (b) requires laboratories to specify the responsibility, authority, and interrelationship of all personnel who manage, perform, or verify work affecting the results of laboratory activities. This means that the laboratory must define the roles and responsibilities of all personnel involved in laboratory activities and specify how they interact with each other.

To meet this requirement, a laboratory must create a clear and concise description of the roles and responsibilities of all personnel involved in laboratory activities. This includes management, technical personnel, and support staff. Additionally, the laboratory must define the level of authority that each person has in their role and how they are accountable for their work.

The laboratory must also define how different personnel groups interact with each other, including communication protocols and reporting structures. This helps to ensure that laboratory activities are performed effectively and efficiently, with clear lines of communication and responsibility.

By specifying the responsibility, authority, and interrelationship of all personnel involved in laboratory activities, a laboratory can ensure that everyone understands their roles and responsibilities, which can help to reduce the risk of errors or misunderstandings. This ultimately contributes to the laboratory's ability to provide accurate and reliable results.

Clause 5.5 (c) requires that a laboratory should document its procedures to ensure the consistent application of its laboratory activities and the validity of the results. Documentation is an essential part of quality management systems, and it helps ensure that laboratory personnel consistently follow procedures.

The laboratory should document procedures for all activities that affect the quality of the results. Documentation should be clear, concise, and unambiguous. It should include all necessary information, such as instructions, forms, and checklists, to ensure that laboratory activities are carried out consistently and accurately. It is essential to ensure that documents are up-to-date and that any changes to procedures are properly documented and communicated to all relevant personnel.

Proper documentation helps to ensure that laboratory personnel is following established procedures, which is important for quality control and assurance. It also provides a record of activities performed, useful for audits and inspections by accreditation bodies or regulatory agencies.

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