The best preparation for an external ISO9001 audit
We talk to quite a few QHSE and KAM Managers. And whatever they are doing at the time, the similarity is that they are always on their way to the next audit. But there is also a difference. One invariably has spots on the neck from stress in that run-up. The other doesn't worry too much about it and goes through it whistling. How do you prepare for an external audit? What makes the difference between stress and relaxation? We're going to answer those questions here.
Understand the standard
Okay, take a breath and then get started. You don't have to shoot straight into action mode. To start, it is important that you are fully aware of the content of the standard and how it applies to your organization. The various aspects of a standard may cover quality management, risk management, leadership and commitment, your organization's processes and continuous improvement. If you want to get a good idea of this standard, you can find information on the International Organization for Standardization (ISO) website.
Your QMS up to date
Everyone involved with ISO9001 has a QMS or QMS. That's a system you use to make quality manageable in your organization. That can be a digital repository of documents that you use manually to bring quality management to life. We still encounter constructions where Word and Excel in combination with Sharepoint and Power BI are used as separate tools. It can also be an integrated digital QMS - such as ISO2HANDLE - that allows you to work interactively on continuous improvement. But whatever system you use, make sure it's in order.
Check that your quality manual, procedures, work instructions and forms are complete and up-to-date. And also make sure changes are properly recorded. In a manual system, you need to keep a record of changes. In your ISO2HANDLE system, automatic version control is already integrated and you can see how thousands of versions differ from previous and subsequent versions.
Also, make sure your processes are well described and record where process responsibilities are placed in the organization. Your QMS is also where you record your KPIs.
First an internal audit
The purpose of an internal audit is to tighten up in advance all the issues that will be raised in an external audit. Proper preparation begins with preparing an audit plan using a checklist that covers all the relevant requirements of ISO9001. During the internal audit, you try as hard as you can to identify any deficiencies (non-conformities). You can then resolve those deficiencies before the external audit begins.
Engaging employees
An audit is a great opportunity to put quality management on the agenda and involve your colleagues. You can train colleagues in an internal meeting about the ISO9001 standard and their role in the QMS. On the one hand, you want to create awareness, but a training course is also a good way to connect with practice. Let colleagues think for themselves about how ISO9001 fits in with their work. You can also prepare colleagues for conversations with the auditor. For example, if they are asked about their roles and responsibilities, it's great if they can tell that, but also where to find that information in company policy.
Assessing risks and opportunities
Before going into an external audit, you want to have a good idea of the risks and opportunities for each process used in your company or organization. And of course, with risks come control measures. Check in advance that you have control measures in place for each risk and that they are effective and well documented. The risk component in ISO2HANDLE gives you an exact overview of all described risks and their development over time. For each risk, you can immediately see which control measures you have taken and what the status is of their implementation. Your risk matrix shows which residual risks still exist and what measures have been implemented to deal with them.
Management Reviews
Management reviews are intended to be conducted regularly as part of ISO9001. These will cover topics such as QMS performance, customer satisfaction, audit results, the status of improvement actions, and risks and opportunities. It is of course very important that the output of these reviews be well documented.
Attention to customer satisfaction
Customer feedback is essential to the organization's ability to improve. Therefore, analyze that feedback and document how complaints are handled and improvement actions implemented. Show your auditor what actions you have taken (or initiated) to improve customer satisfaction.
Demonstrate continuous improvement
The process you put in place to cause continuous improvement is the heart of your quality management. Therefore, you would like to show your auditor how you have organized this process. So show how you resolve non-conformities and take preventive measures. Use KPIs and other measurable (SMART) goals to demonstrate improvements.
Audit-friendly work environment
Before an auditor visits your company, you naturally check that the workstations look neat and organized. Preferably, you announce your internal inspection in advance so your colleagues can ensure an orderly workplace. You can also check at this stage whether processes, protocols or procedures are known and followed. Organize your documentation so that it is accessible to your auditor. If you have a digital audit system like ISO2HANDLE's, simply give the auditor an auditor login to your system. This saves an enormous amount of work and is greatly appreciated by auditors.
Communicate with your auditor
Some QHSE/CAM managers stiffen slightly as the audit nears. A bit like a rabbit in the headlights of an oncoming BMW. That's not necessary. An auditor may ask tough questions, but your common goal is always to level up and improve the quality of the organization. So there is equivalence, remember. You can request the audit agenda from your auditor in advance. Ask questions if you don't fully understand parts of that agenda. Also ask the auditor what his or her focus points will be.
Furthermore, it is convenient to arrange some practical things. Such as a quiet working space for your auditor and a contact person, who accompanies the auditor during the audit.
Preparing for typical audit questions
Typical questions to expect during an audit are "how do you ensure that processes are carried out consistently?", "how do you measure and assess customer satisfaction? And 'how do you handle non-conformities and improvement actions?' Ideally, all your colleagues will have simple and factual answers to these questions. If you have a digital audit system such as ISO2HANDLE, then you can not only tell how you do things, but you can also show it directly and thus demonstrate that you are not talking nonsense.
Relax (but not too much)
If your preparation has been good, you can go through the audio process relaxed. Good preparation is at least half the battle. But at the same time, guard against feeling like you know it all and not being open to feedback and improvement. Because that is precisely what makes auditioning meaningful. Someone who looks at your processes and measures with a different eye than you, wants to help you improve things. So show that you are open to feedback and improvement.
