The ISO 9001 audit checklist is a key element for conducting or planning for a process audit for quality management system in any organization. ISO 9001 is a tool for considering Audit checklist requirements, including quality management system requirements, process performance criteria, and documentation created to avoid process. Now, when it comes to performing the laboratory procedure, there are some requirements that need to be considered when preparing an ISO 9001 Audit checklist.
How to Use ISO 9001 Audit Checklist
The audit is a process, based on systematic activities which are carried out to examine or measure the conformity of any process. In order to audit any process, the auditor uses a checklist to gather evidence to show that the process meets the requirements defined in the criteria. The example checklist above is specific for one laboratory. When performing a laboratory audit, the criteria for an audit will include two major factors. One would be the prescribed process requirements for that particular laboratory, and the other would be the ISO 9001 standard requirements for the ISO 9001 procedure.
If the laboratory does not have defined documentation for its processes, the auditor will be looking at process activities based on ISO 9001 standard requirements. In the results of the audit, there will be a non-conformity in the process because the requirement for documented information is not met. The lack of documentation means that corrective action will be necessary by the process owner, and noted in the result of the audit.
The goal of the audit checklist is to review the effectiveness of the process
To audit the laboratory’s ISO 9001 compliance, will use the Auditor checklist to find evidence that laboratory procedures meet ISO 9001 requirements. Where the laboratory has not maintained process documentation, the auditor will use the general ISO 9001 standard requirements to review the process. One thing that should be clearly understood is that the purpose of using the audit checklist for the laboratory is to review the effectiveness of the process, and to ensure that non-consistency does not occur. The idea is not just to seek out non-conformities, the goal of the ISO 9001 Audit checklist for a Laboratory is to review the process and confirm that the records provide evidence that the process meets its requirements. The auditor only raises concerns about a corrective action to have the process owner correct instances when the process does not meet requirement.
Benefits of an Auditing Checklist
ISO 9001 provides an audit checklist that organisations are required to use when conducting internal audits.
The ISO 9001 audit checklist includes questions for assessing an organisation’s context, leadership, planning and quality management systems, support structures, operations, performance evaluation and areas for improvement.
- Checklists provide a reference in the planning of future audits.
- Audits proceed more smoothly when auditors know the specific requirements of the audit and further introduce consistency and objectiveness to the process.
- The results documented on the checklist can be used as an internal communication platform to motivate for corrective measures and improvements.
- The checklist becomes a repository for the findings of the internal audit and form part of the organisation’s requirements management documentation.
- A completed checklist serves as evidence that an internal audit was conducted and may be reviewed by external auditors.