ISO 9001 audit checklist for laboratory

An audit checklist is a key element for conducting or planning for a process audit. Considering the requirements for ISO 9001 standard, an audit checklist is a tool consisting of questions taken from the quality management system requirements, work performance criteria of the process and the documentation generated for the process that is going to be audited. Now, when it comes to auditing a laboratory process, there are certain requirements which an auditor should consider while preparing the audit checklist.

ISO 9001 laboratory process flow steps:
1) Receiving test samples
2) Classification of test samples
3) Preparation for testing
4) Performing test analysis
5) Generation of test reports

Laboratory audit checklist preparation

Generally, laboratories are based on two working principles: either they work in any organization to perform tests and analysis on certain products, production processes or operations, or the laboratories work independently as a third party to perform tests and analysis on provided samples from clients/customers.

Whichever criteria is being followed in any laboratory, certain process flow steps are followed:

1) Receiving test samples
2) Classification of test samples
3) Preparation for testing (conditioning, apparatus preparation or other pre-requisites)
4) Performing test analysis
5) Generation of test reports

In performing these five basic operations, there are several things that need to be taken care of to produce effective test results. They can include documentation of test procedures, competence of personnel performing tests, fitness of testing equipment, environment in which tests are being performed, measurement traceability of test results, and input/output criteria for performing test analysis.

There are a few constituents mentioned below that should be incorporated in an ISO 9001 Laboratory audit checklist:

1) Risks and opportunities related to laboratory operations (if applicable)
2) Objectives and targets of the laboratory and planning to achieve them (if applicable)
3) Resource requirements and their provision to perform laboratory operations (manpower and machinery)
4) Competence of personnel performing test analyses
5) Fitness records for testing equipment (Calibration records)
6) Documentation maintained for laboratory processes
7) Sample-taking criteria, retained information and classification of samples and their identification
8) Retained information for test results
9) Control of non-conforming test results

If there are certain requirements for process operations defined in the laboratory’s documented procedures, then the questions related to those requirements can be asked through audit checklists during an audit. For more information, see the article ISO 9001 Audit Checklist to get more advice which can help with your audit preparation.

If there is defined criteria for retention of records, then an auditor can check the records based on the criteria in the process documentation.  The table below gives examples, based on a sequence of laboratory activities, which show how an auditor can use an audit checklist to verify the lab’s different activities.

ISO 9001 for laboratories – How to develop an audit checklist

Because these questions are based on the guidelines of ISO 9001, an auditor can have a set of questions which are based on a laboratory’s specialized functions. The questions being asked will depend on the nature of the tests being performed.

How to use 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. While conducting a laboratory audit, the audit criteria will consist of two major things. One is the defined process requirements for that particular laboratory, and the other will be the ISO 9001 standard requirements for a process.

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. Learn more about an ISO 9001 audit in the article How to prepare for an internal audit.

The goal of the audit checklist is to review the effectiveness of the process

To audit a laboratory’s conformity with ISO 9001, auditors will use checklists to find evidence that laboratory processes meet the requirements of ISO 9001. Where laboratory has not maintained process documentation, an auditor will use general ISO 9001 standard requirements to review the process, as in clause 8. One thing that should be clearly understood is that the purpose of using an audit checklist for a laboratory is to review the effectiveness of the process, and to ensure that non-conformities do 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 requirements.

Sign up for this free online training ISO 9001 Internal Auditor Course to learn more details about developing audit checklists.