How to prepare for an ISO 9001 audit

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, conduct a spot check of all QMS processes and practices to ensure alignment with ISO 9001 audit standards. Consequently, the internal audit should highlight areas needing review and the updating of shortcomings.

In addition, completing a comprehensive ISO 9001 audit strengthens your QMS in both the short and long term. Therefore, before facing an external audit, review and prepare the following items:

Review documents and records for ISO 9001 audit

1. Verify that your records are current and being used for the correct purpose to meet ISO 9001 audit requirements.
2. Check that all documents have been reviewed and updated if needed. Ensure they are approved, communicated and followed by everyone involved in the process or activity.
3. Make sure any obsolete documents have been removed from circulation and are no longer being used.

Organize the site for an ISO 9001 audit

• Of course, your site should already stay organized and clean. However, before going into an external audit—especially an ISO 9001 audit—you must 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. 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, auditors may interview employees, so workers must feel comfortable answering questions about how they perform their job duties. In particular, this requirement becomes especially important during an ISO 9001 audit.
• Discuss with the interviewees what to expect so they can prepare ahead of time.
• Everyone must receive proper training to perform their duties. In addition, you must confirm that this training has been completed and retain 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.
• You must review the quality system for accuracy and discuss it 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

1. Employees must perform all processes, including critical ones, correctly.
2. In addition, employees must follow all procedures, work instructions, and related documentation exactly as written to comply with the ISO 9001 audit standard.

Review your corrective action process

1. You must review the quality system for accuracy and discuss it with personnel. As a result, everyone gains a clear understanding of what the site has agreed to in terms of quality.
2. Moreover, record each finding, review it, and assign an action to someone for completion. As a result, this ensures accountability throughout the process.
3. After you complete and close a finding, you must follow up to confirm that the corrective fix works effectively.

If you have been through an external ISO 9001 audit then you have a pretty good idea of what to expect. However, if you have not, this list will help you prepare. Above all, the internal audit process prepares you more than anything else. When you use the internal audit process correctly, it strengthens your QMS. It ensures that your external audit goes much smoother.

In addition, if you have had an external audit in the past, the external auditor will review that audit to check the recorded findings. They will also expect to see a plan for closing any open findings. Auditors may request evidence of closed items relevant to ISO 9001 requirements.

Moreover, when auditors want to verify a closed item, they may review documentation or ask to see the corrective action in the field. Either way, it is a good idea to review the previous audit before your next one. This ensures you feel confident about the status of all findings.