In order to meet all the requirements of ISO 9001 Standard, it is critical to prepare and follow an audit checklist. This is a tool that consists of a series of questions taken from Quality Management System requirements, performance measures, and documentation generated for the process which is being audited. Every business needs ISO 9001 internal audits. When it comes to a laboratory, there are some important requirements that need to be audited, and this article will discuss these requirements. First, let’s focus on preparation.
How to Prepare an Audit Checklist
Most laboratories are as follows –
- They perform tests and analysis on specific products, production processes, or operations, or
- They independently work as a third-party to conduct tests on the samples collected from their clients.
A laboratory deals with a number of processes. In the list below are five major processes and record checking activities associated with each process:
- Collecting test samples-Identification, traceability, handling, storage, and receiving records,
- Labeling the test samples- Traceability, marking documentation, and non-conforming samples,
- Preparation for testing- Process documentation, testing requirements, and preparation criteria,
- Conducting test analysis-Process documentation, machine fitness or calibration, personnel competence, and process records,
- Generating test reports-records, control of non-conforming samples, and retention of records.
While dealing with these basic operations, generate accurate test results. These things may include documentation of test procedures, the competence of personnel performing tests, efficiency of testing equipment, environment in which tests will be performed, measurement traceability of the produced results, and input/output requirements for conducting test analysis.
Whenever preparing an ISO 9001 audit checklist for your laboratory, consider these aspects:
- Risks and opportunities related to laboratory functions,
- Objectives, targets, and planning to meet them,
- Resource requirements (human resources and machinery)and provision to conduct laboratory operations,
- Personnel performing test competence,
- Documentation for laboratory processes,
- Requirements for collecting samples,
- Retained information for test results,
- Control over non-conforming test results.
If there are any specific requirements for process operations, then questions regarding those requirements can be included in the checklist. If your laboratory has defined requirements for retention of records, then an auditor should check the records and consider the requirements stated in the process documentation.
How to utilize the audit checklist
An audit is an evaluation method that is based on systematic activities, and can be carried out to determine the conformity of any process. To audit any process, the auditor should use a checklist, as the checklist will gather evidence for ISO 9001 internal audits. Furthermore, the checklist will be used to demonstrate that a process meets the requirements stated in the criteria. The audit criteria must consist of two major elements, process requirements relevant to your laboratory, and defined ISO 9001 requirements for a process.
If your laboratory does not define documentation for its processes, the auditors will evaluate the process activities based on ISO 9001 Standard requirements. In the audit result there will be nonconformities because the requirement for documented information was not fulfilled. Lack of documentation implies that corrective actions are necessary by the process owner.
A Final Takeaway
While auditing a laboratory’s conformity with ISO 9001, the auditors should audit checklists to find evidence that the laboratory processes properly meet ISO 9001 requirements. If the laboratory does not carry out process documentation, the auditor will use general ISO 9001 standard requirements.
From the above discussion, it is clear that maintaining an audit checklist is very important. A proper checklist will ensure that ISO 9001 internal audits are organized and smoother.