Preparing employees for an ISO audit is a common concern in organizations. The ISO audit plays a crucial role in demonstrating compliance with international standards set by the International Organization for Standardization (ISO) and other regulatory bodies. The audit process involves assessing the quality of operations and adherence to defined standards.
There are two main types of audits: internal and external. Internal auditors evaluate employees’ knowledge and compliance with company rules, policies, and procedures. They also assess whether employees have received proper training and work in satisfactory conditions, such as the ability to work remotely. External auditors establish their own procedures when conducting an external audit. For example, when an employee fills out a form and signs it as “completed,” the auditor can verify the accuracy of the form before departing from the office.
But preparing employees for this kind of event can be a challenge, especially if many of them have never experienced an audit before. Here are three tips for making sure everyone knows what to expect during an audit:
The right time for an ISO audit
The question, of how to prepare employees for ISO audit is directly related to the question, of how ready the organization is.
The first step in preparing for an ISO audit is to make sure your company is ready. This involves ensuring that you possess the necessary documentation, that your employees are aware of what to expect, and that they receive proper training to answer questions accurately and promptly.
You should also take into consideration any recent changes or developments at your company that may impact the audit process. For example, if you recently had to recall one of your products because of safety concerns or if you just started using new processes or procedures for managing product quality, these details could change how an auditor evaluates risk factors related to internal controls over financial reporting (ICFR).
In turn, this might require auditors to ask more pointed questions about those topics during the actual audit itself—so it makes sense for employees who work on these issues on a regular basis to be familiar with them ahead of time!
Once all preparations are complete and everyone is aware of their roles and responsibilities during the audit process, including when auditors will interact with individuals from their respective departments, training can commence.
Employees should know what to expect during an ISO audit
During an ISO audit, it is important for employees to be aware of what to expect. The audit team will arrive at a prearranged time, requiring all employees, even those who did not participate in the initial meeting, to be ready to respond to inquiries regarding their roles and responsibilities. This includes any recent or expanded duties since the previous audit.
Employees should also be prepared to present relevant documents that substantiate their responses during the audit. Additionally, they should be able to articulate the impact of any alterations in procedures or policies on areas such as quality management, environmental management, and occupational health and safety.
Employees should be able to provide a trail of any changes. This is easier if the company has Quality Management Software that comes with an Audit trail. But if not, employees should have documents that show the trail.
Employees should also be aware of all the policies related to their work, e.g. the Quality policy. Employees should possess knowledge of the fundamental elements of the ISO audit and have a clear understanding of how these elements align with their specific operational roles.
Here are some questions which can be asked during an audit;
- What is the document control procedure in your area (Related to Document Control)
- Show me the action item X and show me if the effectiveness was documented (Related to CAPA)
- What are the findings of the last internal audit? Are any of them past the due date?
Closing meeting with the audit team
The closing meeting conducts a thorough review of the audit, ensuring that all concerns are addressed and eliminating the requirement for further meetings with the audit team. It should take place within 24 hours of the audit’s conclusion or as soon as possible thereafter.
Key stakeholders, including the team leader and representatives from QA, HR, and finance, should attend the closing meeting. The meeting should cover the following:
- Summarizing the discussions held during each session, referring to notes if necessary. Any overlooked items can be included in an action plan for future audits.
- Summarizing any changes implemented during the audit. This may include new policies or procedures introduced by the company. It is important to document these changes for future reference if customers inquire about them.
- Reaching an agreement on the timeframe for the next ISO certification process.
The team leader should arrive at the closing meeting fully prepared, taking care to address and account for all the mentioned points.
We hope this article has provided you with some insight into what to expect during an ISO audit. Remember that the most important thing is to have a prepared team that knows all of the right questions to ask and can answer them confidently. If you follow these tips and keep up with your own training programs, then passing an ISO audit should be no problem at all!