Laboratory activities in Section 5 - Structural Requirements

Section 5 refers to legal business, organisational structure and management responsibility. Typically this is included in the Quality manual. You then have other procedures, appendices and associated records available to provide evidence that the stated approach is followed.

Clause 5.1 refers to the need for a legal entity.

5.2 Requires you to define who the Senior management are and who holds the top management position. This is for resource allocation (budget), dealing with any conflicts of interests in the laboratory. That is who has overall responsibility to ensure policies are supported and that quality /accreditation objectives are met. This person signs the quality  policy, typically approves the quality manual and chairs or oversees the Management Review.

5.3 Requires you define the scope of work (what you do) and state which activities comply with ISO 17025. Those are the tests you will apply for accreditation for.

5.4 Requires you to look beyond just your operational and quality preferences, the mandatory requirements of ISO 17025 and those of your accreditation body. You need to consider and include all applicable regulations and requirements of interested parties. For example, Safety laws, labour laws and any requirements of your sector for the laboratory to be registered or certified with a particular regulatory body.

5.5 a) Requires you have a clear management structure documented and to provide an organogram as defined.

5.5 b) ties in with clause 6.2. Personnel must be informed of their roles and this must be documented. For example, a small laboratory may not have a person appointed as a quality manager; however senior analyst may be required to perform the role of a quality manager together with other functions. This must be clearly stated and communicated.

5.5 c) This ties in with clause 8.2 Management system documentation. All mandatory requirements must be met plus any needed (processes, procedures and records) to control your specific risks (operational and quality) as necessary. These requirements should be directed by your policies, objectives and method performance. For example if turnaround time (TAT) for resulting is an objective, you need to document a way and use charts or other tools to monitor your success and risks of not meeting TAT.

5.6 Ties in with clause 6.2. Personnel must be assigned to the activities listed in a to e.

5.7 Is directed specifically at laboratory management. You have to define how communication is going to take place, such as how often you have meetings and how management idevelop a quality culture in the laboratory to meet your quality objectives. Secondly, management must have a system in place for change control so that  laboratory personnel, even if authorised, don’t just move ahead with changes to the management system to adopt opportunities for improvement without considering the risks to current operations and quality.

The Whitepaper Clause-by-clause explanation of ISO 17025:2017 may assist you, available at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/