Preparing for an annual ISO audit

January 24, 2017

Preparing for an annual ISO audit

Mark Blackwell


So it’s that dreaded time of year again. No, I’m not talking about the time of year when we need to start coming good on all of our New Year’s resolutions. I’m talking about something much worse than that: ISO audit time. Everything is on the line – your certification, reputation, and official affirmation that your QMS is the well-oiled machine everyone’s worked hard to develop and maintain. Here are a few tips I use to ensure my ISO audits are as less stressful as possible.

1. Be Prepared.

Procrastination will lead to disaster. If you’re going to wait until the last week before your audit to start reviewing documentation, records, process conformance, etc.  you’re probably in for a very rough time. It’s critical that all aspects of your QMS are functioning properly throughout the year. Use your internal audit process to check on the health of your system regularly. I schedule small internal audits monthly, spread out over the entire year, in order to keep my finger on the pulse of the overall health of the QMS. Remember to use CAPA analysis to address problems you identify, and be prepared to answer auditor questions on any gaps you’ve found. Close out NCs in a timely manner and record OFIs as they arise. Being diligent in ensuring records are kept up throughout the year can save you a huge headache in preparation later.

2. Stay cool and confident.

There is absolutely no good that can come out of a heated argument with an auditor (believe me). I realize that it can often times be very frustrating when bombarded with questions about processes, procedures, documentation, records…etc. during an audit, and that some auditors can come across as untrusting and seemingly determined to catch you in a lie, but it’s important that the auditor sees that you are in control of the situation and that you genuinely believe your QMS is meeting your customer’s requirements, and the requirements of the standard.  Don’t let an overly aggressive auditor cause you to doubt your system or yourself.

3. Be humble.

It’s important to remember that your auditor has a wealth of knowledge and experience in the area that he or she is auditing. If there is a gap identified, be open to hearing what the auditor has to say. Oftentimes, he or she have seen similar situations in other companies and are happy to share real-life solutions. I use these opportunities to get insight into how other companies do things, and on several occasions have went on to implement changes and improvements based on suggestions from auditors. I always keep a notepad at the ready and record auditor feedback as it is being given.

4. Be a good host.

While an auditor is at your facility, it is important that they are made to feel comfortable. Make sure they are offered coffee and water, and that you show them where all necessary facilities are. In most cases, lunch is provided by the auditee, so it’s important to make sure any special food requirements are discussed with the auditor(s) before ordering lunch. This will go a long way in ensuring you receive a fair audit by a happy auditor.

5. Give them space.

Auditors not only have to assess a huge amount of information, but they need to formally document all of their findings. This process usually occurs during the time allotted for the audit. Once the auditor starts working on their report for the day, excuse yourself and let them know where they can find you if they have any questions. They’ll appreciate the space and privacy, especially if there are multiple auditors on site that day.

Most of this is common sense and not ground breaking information. But I hope, at the very least, it helps make the process a little less stressful for someone. And by the way, we just passed our fourth ISO audit in 3 years and have yet to receive a major NCR! 

Preparing for an annual ISO audit