ISO/IEC 17025:2017 Clause 5.1 to 5.3 - Structural requirements

 The ISO: 17025:2017 clause 5 Structural requirements emphasize several key elements, including the legal status of the laboratory, its organizational structure, personnel identification and management, and the availability of personnel responsible for maintaining the integrity of the management system. Additionally, the standard emphasizes the need for clear and consistent documentation of laboratory procedures to ensure the accuracy and validity of results.

Clause 5.1 of ISO: 17025:2017 specifies the requirement for a laboratory to have a legal entity in order to comply with the standard. A legal entity is defined as an association, corporation, partnership, proprietorship, trust, or individual that has the legal capacity to enter into agreements or contracts, assume obligations, incur and pay debts, sue and be sued, and be accountable for illegal activities. In other words, a legal entity is a recognized and distinct entity under the law.

Having a legal entity is crucial for a laboratory because it provides a basis for its operations and management. A legal entity allows the laboratory to enter into contracts with its clients, suppliers, and other stakeholders, and it also enables the laboratory to assume obligations and incur debts. Furthermore, a legal entity provides a framework for accountability, as the laboratory can be held responsible for any illegal activities that may occur.

To fulfill the requirement of legal status, the laboratory must provide documentation supporting its legal entity status. The standard specifies that the laboratory must provide a copy of the Certificate of Formation, Business License, Tax ID Number, Trust Registration Act, Limited Liability Partnership, or government notification or declaration. This documentation serves as proof of the laboratory's legal entity status and is necessary for the laboratory to operate within the legal framework of the jurisdiction in which it operates.

Governmental laboratories are considered legal entities based on their status as part of a government organization. This recognition is important because it provides a basis for their operations and management, just like any other legal entity. However, it is important to note that governmental laboratories still need to comply with the requirements of the standard, including those related to management, personnel, and documentation, to ensure the quality and reliability of their testing and calibration services.

A legal entity is a fundamental requirement for laboratories to operate in compliance with ISO: 17025:2017. It provides a basis for their operations and management, and it enables them to enter into agreements, assume obligations, and be held accountable for their actions. The laboratory must provide documentation supporting its legal entity status, and governmental laboratories are recognized as legal entities based on their status as part of a government organization.

Clause 5.2 of ISO 17025:2017, the laboratory shall identify the management responsible for overall laboratory operations. This means that the laboratory must have a designated management team that is responsible for the effective functioning of the laboratory, ensuring that it meets all the requirements of the standard.

Identifying the management team responsible for the laboratory is important because it provides a clear structure and hierarchy for decision-making and accountability within the organization. The management team is responsible for ensuring that the laboratory's policies, procedures, and operations comply with the requirements of the standard and any relevant regulatory or legal requirements. They are also responsible for providing direction and support to the laboratory staff, promoting a culture of quality, and ensuring that the laboratory's resources are utilized effectively.

The management team is expected to have the necessary knowledge, skills, and experience to effectively manage laboratory operations. This includes having a good understanding of the laboratory's testing and calibration activities, as well as the technical and regulatory requirements associated with these activities. In addition, the management team should possess strong leadership and communication skills to facilitate effective collaboration and communication within the laboratory.

Identifying the management team responsible for the laboratory is an essential aspect of compliance with ISO 17025:2017. This ensures that the laboratory has a clear structure and hierarchy for decision-making and accountability and that the necessary expertise and resources are available to manage laboratory operations effectively.

 

Clause 5.3 requires the laboratory to define and document the range of laboratory activities for which it conforms to the standard. This means that the laboratory must clearly identify and document the specific testing activities that are covered by its compliance with the standard. The laboratory can only claim conformity with the standard for the specific range of laboratory activities that it has documented.

The documentation of the laboratory's range of activities is important because it ensures that the laboratory's compliance with the standard is focused and clearly defined. This documentation also helps to prevent confusion and misunderstandings about the scope of the laboratory's accreditation.

It is important to note that the laboratory can only claim conformity with the standard for laboratory activities that are performed in-house. The standard specifically excludes externally provided laboratory activities on an ongoing basis. This means that if the laboratory outsources any of its testing activities, it cannot claim conformity with the standard for those activities.

To comply with this clause, the laboratory should carefully review and document all of its testing activities. This should include a clear description of the types of samples tested, the methods used, and any relevant standards or regulations that apply. The documentation should be comprehensive and should clearly define the laboratory's scope of accreditation or certification.

Due to limitations, we covered only clauses 5.1 to 5.3 of ISO 17025:2017 in this article. To keep the coverage brief, we mentioned that we would be splitting it into multiple blog posts.

 

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