Where the laboratory has not maintained process documentation, the auditor will use the general ISO 9001 standard requirements to review 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. The goal of the audit checklist is to review the effectiveness of the process The lack of documentation means that corrective action will be necessary by the process owner, and noted in the result of the audit. In the results of the audit, there will be a non-conformity in the process because the requirement for documented information is not met. 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. 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. When performing a laboratory audit, the criteria for an audit will include two major factors.

The example checklist above is specific for one laboratory. 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 audit is a process, based on systematic activities which are carried out to examine or measure the conformity of any 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. ISO 9001 is a tool for considering Audit checklist requirements, including quality management system requirements, process performance criteria, and documentation created to avoid process. 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 audit checklist