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12 November 2020
You have completed your ISO 9001 implementation and the day of the certification audit is approaching fast. Do you need to prepare anything? What can you do to increase your chances of success? We'll share our insider tips and show you how to prepare your company, management, and staff for a successful certification audit.
The ISO 9001 certification audit will be similar to a (good) internal audit. The auditor will verify that your company's quality management system complies with ISO requirements and is working well for your organization.
No matter if physically on-site or remotely through video conferencing, the auditor will watch work being performed, observe the work environment, and interview personnel at all levels of the organization, including department management and executives. The auditor will request documents, look at records and data, and cross-check what he has seen and heard.
It's quite normal for employees to be unnerved by external auditors – something which could lead to mistakes that impact on the success of the certification assessment. So what should you do to prepare, put staff at ease, and increase your chances of success?
Communicate what will happen on the day and what to expect from the auditors.
Explain that the auditor's job is not to find fault but to establish that the system is working.
Emphasize that the audit is not pass or fail but that certification can be issued after correction of any problems.
Show employees how to best interact with an auditor.
Teach employees how to respond to common auditor questions.
An easy yet effective way to prepare staff for the external auditor is our video course. It's available in DVD and LMS/network versions.
It's important to remember that ISO 9001 is a management tool. Your auditor will verify that management understand this tool and actively use it. How will the auditor verify this and establish compliance with the standard?
The quality policy should reflect the believes of top management and guide the organization.
Leaders actively communicate the quality policy, its meaning and importance.
There is a mechanism that ensures that organizational goals fall in line with the quality policy.
Results of audits and other performance indicators enter the decision making progress.
The QMS is fully integrated into strategic planning and other responsibilities of executives.
Top managers have a sufficient understanding of ISO 9001 requirements and their application.
Every certification audit includes an (extensive) interview of one or more top managers. A bad performance during the interview not only jeopardizes successful certification but also embarrasses. Based on our experience it is wise to prepare top management well prior to the audit; a concise online course would be an excellent choice.
There are certain elements of a quality management system where auditors often find problems. For example, one of the most common nonconformities is related to document control. Other common areas include internal audits and the effective correction of identified issues, management reviews and their adoption as a real management tool, calibration of monitoring and measuring equipment, and employees and their department metrics supporting the overall quality objectives. Below are a few preparation tips on how to prevent common nonconformities.
Have all personnel check their work area for uncontrolled, unauthorized or superseded documents. This includes "personal" copies and printouts, as well as sticky notes.
Have your audit manager review audit reports and verify that all nonconformities have been resolved effectively.
Check that there are complete records of at least one management review. Prepare the executive team to demonstrate their use of management reviews as a basis for executive decision making.
Get staff to check their monitoring and measuring equipment to ensure it's properly maintained and calibrated, identified as such, and that there are records to prove it.
Have managers and staff remind themselves of their personal or department objectives, and how they support the quality policy and quality objectives of the company.
Ensure that training records are complete and available. Certification auditors frequently check ISO 9001 related training records (employee introduction, executive training, auditor training).
Use the audit preparation as an opportunity to have everybody organize and tidy up their work areas.
As part of the certification audit, your auditor will observe work being performed and ask questions. Auditors also commonly interview managers and executives.
As preparation for the audit, explain that auditor questions should be answered truthfully and that the auditor will ask for evidence to support answers. Nevertheless, staff shouldn't volunteer additional information or steer the auditor towards issues not pertinent to the subject. Also, make everybody aware that they should ask the auditor or the accompanying member of the implementation team for clarification if they don't understand what the auditor is asking. While it would be inappropriate for the escort to answer the question for them, it's acceptable to interpret the question into language your employees understand.
Audits may cover any requirement of the ISO 9001 standard, but as a general rule the following audit questions should be expected:
Quality policy: Do you understand the content of the quality policy? How does the quality policy relate to your work? How do you contribute to the objectives of your company's quality policy?
Objectives: What are your objectives, how do you achieve them, and how do you measure success? How do your objectives relate to the quality policy?
Customer focus: How does your work affect your company's customers? Do you know what the customers think of your company's products or services?
Customer requirements: How do you know if the products you are producing meet customer requirements? How do you know you perform your work correctly?
Document control: Are your work instructions current? How do you know? Is there a chance that you mistakenly use obsolete documents? Show me the instructions for the XYZ process.
Process interaction: Do you know how your work processes affect other processes? Do you understand what impact your work has on other processes?
Suppliers: How do you select suppliers? Are suppliers approved? And if so, by whom? What do you do if a supplier doesn't perform according to expectations?
ISO 9001 standard: Show me the ISO 9001 standard! (Only applies to internal auditors and those responsible for implementation and documentation of ISO 9001 requirements).
Obviously not all audit questions apply to all employees and managers. Also, remember that these are not meant to be pass-fail questions. Instead, the auditor is using these questions to establish if the ISO 9001 system is properly and effectively implemented.
The certification audit tends to be a stressful experience and particularly challenging for department managers. Being well prepared for the audit and knowing what to expect not only reduces stress but also increases the chances for success. So be sure to prepare your company properly in the days leading up to the big day.
If you are uncertain about your company's readiness, you may want to consider our internal audit service. With this service you'll get our guarantee that you'll pass your subsequent certification audit. Just the peace of mind could be worth it but the service also adds value through the tips and best practices shared by our experienced lead auditor.
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