Strahinja Stojanovic What is an ISO 9001 audit?
An ISO 9001 audit is a documented, systematic, and objective process for gathering facts.
What is an ISO 9001 Audit Checklist?
An ISO 9001 audit checklist is a key element in planning for and carrying out a process audit, which is a requirement of the ISO 9001 standard. The checklist for any internal quality audit is composed of a set of questions derived from the quality management system standard requirements and any process documentation prepared by the company. The checklist is created in step two and used in step three of the Five main steps in ISO 9001 Internal Audit.
ISO 9001 Audit Checklist Preparation
As part of the internal quality audit preparation, the ISO 9001 auditor will review the ISO 9001 requirements and process documentation defined by the company for the process to be audited. While it may be beneficial to use an audit checklist template when preparing for an audit, it is important to ensure that the checklist be adapted to the process of the organization, and that it is not a generic process. So, the steps of creating an audit checklist would be reviewing the ISO 9001 standard, and then creating questions to ask when reviewing records and personnel of the process. The goal is to find evidence that the process is meeting its own requirements.
As an example, the ISO 9001 clause for management review inputs requires that management review include:
- information on results of audits,
- customer feedback,
- process performance and product conformity,
- status of corrective and preventive actions,
- follow-up actions from previous management reviews,
- changes that could affect the quality management system, and
- recommendations for improvement.
If the company process requires that management reviews produce minutes of meeting as a record, then the internal audit checklist could request that the auditor review the minutes of meetings and question that each piece of input information was presented to the management review meeting for assessment.
As this would only be one question on a checklist for reviewing the management review process, the ISO 9001 audit checklist would contain the many questions required to assess the process.
Using the ISO 9001 Audit Checklist
To audit ISO 9001 the auditors will use the checklists created and look for evidence that the process being audited meets the requirements of the defined process. Where process documentation is not present, it is often relevant to use the requirements of the ISO 9001 standard, focusing on reviewing the process suppliers, process inputs, process steps, process outputs and process customers to ensure that they are consistently understood by the employees using the process. The idea is to review for the effectiveness of the process, and to ensure that non-conformances could not be caused because the process does not have a written document describing it. Again, the goal of using the internal audit checklist for ISO 9001 is to review the process and to confirm that the process records provide evidence that the process meets its requirements. Only secondly does the auditor raise a corrective action to have the process owner correct instances when the process does not meet requirements.
For a better understanding of the ISO 9001:2015 internal audit process, see this free online training: ISO 9001:2015 Internal Auditor Course.
