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. Below 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
- This should already be the case. Your site should always be organized and clean. But, going into an external audit, you want to make sure you put your best foot forward.
- Auditors will find it much easier to see what is going on in your QMS if they don’t have to wade through clutter. If your site is clean and organized, the auditors appreciate the effort and it makes their job easier.
- Make sure to have any and all records, procedures, forms, etc. available for the auditors.
Prepare your employees
- During an audit, employees can be interviewed so they should be comfortable answering questions about how and what they do in their job capacity.
- Discuss with the interviewees what to expect so they can prepare ahead of time.
- Everyone should be trained properly to perform their duties. Ensure that this has been done and you have retained the records to prove this.
- All employees must know where to find the most current copies of work instructions, procedures and forms needed to complete their tasks.
- The quality system should be reviewed for accuracy and discussed with personnel. This will ensure everyone has a clear understanding of what the site has agreed to as far as quality.
- Discuss the schedule of the audit so your personnel understand what the auditor may be checking and confirming.
Processes must be performing correctly
- All processes, including critical ones, should be performed the correct way by everyone.
- All procedures, work instructions, etc., must be followed as written.
Review your corrective action process
- You must review any and all findings from previous audits. This includes internal and external audits. You must be able to show that they all have been addressed.
- Any findings must be recorded, reviewed and an action assigned to someone for completion.
- When a finding has been completed and closed, there should be a follow-up showing the fix has been effective.
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.