How to prepare for an ISO 9001 audit
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When a site has an external ISO 9001 audit scheduled, the best way to prepare is to perform an internal audit. An effective internal audit can be your best tool to ensure your quality management system (QMS) is successful. During the internal audit, a spot check of all QMS, processes, and practices should be reviewed.
An internal audit should provide an idea of where you need to spend time reviewing and updating shortcomings. Through an ISO 9001 audit, your QMS will become stronger in both the short and long run. Here is a list of things to review or prepare before an external audit:
Review documents and records
- Verify that your records are current and being used for the correct purpose.
- Check that all documents have been reviewed, updated if needed, approved, communicated and are being followed by everyone involved in the process or activity.
- Make sure any obsolete documents have been removed from circulation and are no longer being used.
Organize the site
Prepare your employees
Processes must be performing correctly
Review your corrective action process
If you have been through an external ISO 9001 audit then you have a pretty good idea of what to expect. If you have not, this list should help you get prepared. The internal audit process will help prepare for an external audit more than anything else. If the internal audit process is used correctly, it’ll make your QMS stronger. In turn, your external audit will go much smoother.
If you have had an external audit in the past, then the external auditor will want to review that audit to see what findings were recorded. They will expect to see a plan in place for the closure of any open findings and may also want to see any closed items. If they want to see a closed item then they may review documentation or ask to see the finding in the field. Either way, it’s a good idea to review the previous audit before your audit to ensure that you feel comfortable with where you are with the findings.