Recognize How to Use an ISO/IEC 17025 Audit Checklist for Laboratory

For carrying out or organizing a process audit, an audit checklist is essential. An audit checklist is a tool made by the requirements of the ISO/IEC 17025 standard and is made up of inquiries drawn from the standards for a quality management system, the standards for how well a process is performed at work, and the supporting paperwork. When it comes to auditing a laboratory procedure, there are a few considerations that an auditor should take into account when creating the audit checklist.

Using checklists, auditors will look for evidence that a laboratory's operations comply with ISO/IEC 17025 requirements to assess the compliance of the lab to the specification. An auditor will assess the procedure using general ISO 17025 standard requirements in cases when the laboratory has not kept track of process documentation, as stated in clause 8. It is important to realize that employing an audit checklist in a laboratory serves the dual purposes of evaluating the process' efficacy and preventing non-conformities. The objective of the ISO 17025 Audit checklist for a Laboratory is to analyze the process and make sure that the records show that the process complies with its standards, not merely to look for non-conformities. Only in cases where the process does not adhere to requirements does the auditor raise concerns about a necessary corrective action to be taken by the process owner.

Guidelines for getting prepared for the Laboratory Audit Checklist

Typically, laboratories operate under one of two guiding principles: either they perform tests and analyses within an organization on specific goods, operations, or production processes; or they work independently as a third party on samples that clients or customers supply. There are specific process flow processes that must be followed in any laboratory, regardless of the criteria being used:

• Receiving test samples
• Classification of test samples
• Preparation for testing (conditioning, apparatus preparation, or other pre-requisites)
• Performing test analysis
• Generation of test reports

To get reliable test results, it's important to take a few precautions when executing these five fundamental processes. They can consist of input/output criteria for test analysis, measurement traceability of test findings, test environment, measuring equipment fitness, documentation of test processes, competent test staff, competent testing equipment, and a competent testing environment. Following are a few elements that should be included in an ISO/IEC 17025 Laboratory audit checklist:

• Risks and opportunities related to laboratory operations
• Objectives and targets of the laboratory and planning to achieve them
• Resource requirements and their provision to perform laboratory operations
• Competence of personnel performing test analyses
• Fitness records for testing equipment
• Documentation maintained for laboratory processes
• Sample-taking criteria, retained information, and classification of samples and their identification
• Retained information for test results
• Control of non-conforming test results

The questions relevant to such requirements can be asked through audit checklists if specific requirements for process operations are included in the laboratory's written procedures. If there are established requirements for record retention, an auditor can review the records by those requirements in the documentation. The table that follows provides illustrations based on a series of laboratory activities that demonstrate how an auditor might utilize an audit checklist to confirm the various actions carried out in the lab.

How to use an audit checklist

The auditing process is built on organized actions that are taken to assess or measure a process's level of conformance. To verify that a process complies with the criteria outlined in the audit, the auditor employs a checklist to collect proof. One laboratory-specific checklist is provided in the example above. The two main audit criteria that will be used when performing a laboratory audit are as follows. One is the specifically identified process requirements for that laboratory, and the other is the process requirements specified by the ISO/IEC 17025 standard. If the laboratory does not have clearly defined documentation for its processes, the auditor will evaluate process activities by the standards of the ISO 17025 standard. Because the criterion for documented information was not met, there will be a non-conformity in the process of the audit's findings. Due to a lack of documentation, the process owner will need to take remedial action, which will be indicated in the audit's findings.

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