An ISO 9001 certification audit is a critical step your business undertakes before being declared ISO compliant. The process typically involves an external auditor assessing your Quality Management System (QMS) to ensure you have met all the ISO 9001:2015 requirements for compliance.
Based on how well your business performs, the auditor will either issue your company with the ISO certification or ask for some corrective actions before giving approval. If you think your business is ready for ISO 9001 certification, these tips will help you prepare for a successful QMS audit.
What is a QMS audit?
A QMS audit is a systematic review of an organisation’s Quality Management System. The primary goal is to determine if the system conforms to planned arrangements, including the requirements of the ISO 9001 standard and the organisation’s own documented procedures. The auditor will verify that the QMS is effectively implemented and maintained to achieve quality objectives.
What are the benefits of an ISO 9001 audit?
ISO 9001 audits are essential for any organisation seeking continuous improvement. They provide valuable feedback on performance and highlight areas that need attention. Whether it’s for food businesses or manufacturers, a robust audit process helps maintain a strong quality culture.
Prepare employees for the audit
It is quite normal for your employees to feel nervous about the presence of external auditors in your offices. You need to bear this in mind, as it could lead to some basic mistakes that can get in the way of a successful certification audit.
To increase your chances of approval, you need to prepare your employees adequately and ensure that everyone is at ease before the external auditors arrive. Below are some of the things you can do to prepare them:
- Talk to them about what will happen on the audit day and what they should expect from the external auditors.
- Explain to them that the auditor’s job is primarily to establish if the quality management system works and not to find fault in their work.
- Emphasise to them that the audit process isn’t a test to pass or fail, and the ISO certification can still be issued if any identified problems are corrected.
- Show your employees the best ways to interact with external auditors.
- Teach your employees the best ways to respond to the auditors’ questions.
Give the auditors as much space as possible
In most cases, external auditors follow a specific procedure and plan to conduct an ISO 9001 audit. Your quality management team might prioritise giving some information while leaving out specific details, which might not be ideal for the auditors.
The truth is that the more information the auditors have access to, the more accurate and detailed the auditing report will be. For this reason, it’s best to embrace all opportunities for improved quality procedures and provide complete access to relevant documentation.
Prevent common nonconformities in your quality management system
Undoubtedly, there are particular areas of the quality management systems that auditors often find problematic. The most common variation is related to document control. Other nonconformities include a lack of management review, ineffective corrective action processes, problems with calibration of measuring and monitoring equipment, and all departmental metrics not supporting the overall quality objectives.
The good news is that all these divergences can be mitigated using the appropriate procedures. Here is how you can prevent them:
- Ensure all training records are complete and available.
- Ensure there is at least one complete record of management review.
- Have your staff check all the measuring and monitoring equipment to ensure they’re properly maintained and calibrated.
- Regularly remind the management and staff of their personal and department objectives.
- Use the audit preparation process as an opportunity to tidy up the workplace.
How often should an ISO 9001 audit be undertaken?
An ISO 9001 certification is not a one-time event. To maintain it, your organisation must undergo a cycle of audits. The cycle begins with the initial certification audit. After that, surveillance audits are conducted annually for the next two years. A recertification audit is then required every three years to renew the certification.
This regular schedule ensures the QMS continues to meet the standard and drives continuous improvement. It keeps the system active and prevents it from becoming a set of documents that are ignored after the initial certification is achieved.
What’s the difference between an internal audit and external audit?
The major difference between an internal audit and an external audit lies in who performs the audit and its primary purpose.
An internal audit is conducted by the organisation itself, using its own trained staff or a hired consultant. The main goal is self-assessment – to check the health of the QMS, identify weaknesses, and prepare for external audits. It’s a proactive tool for improvement and ensuring day-to-day compliance. Many organisations invest in auditor training to build this internal competency.
An external audit is performed by an independent, third-party certification body. Its purpose is to provide an impartial assessment of your QMS against the ISO 9001 standard. A successful external audit results in achieving or maintaining your official certification. This process is crucial for demonstrating conformity to customers and stakeholders.
What is the ISO 9001 audit checklist?
An ISO 9001 audit checklist is a tool used by an auditor to ensure that all requirements of the standard are covered during the audit process. It acts as a guide, breaking down the standard’s clauses into a series of questions or checkpoints. This helps the auditor systematically verify that each component of the QMS is in place and functioning correctly.
The checklist typically covers every section of the ISO 9001 standard, from leadership and planning to support, operation, performance evaluation, and improvement. While templates are available, many auditors customise their checklists to fit the specific industry, whether it’s hospitality, manufacturing, or tech. For any organisation, using a checklist during an internal audit is an excellent way to prepare for the external one.
How can Citation Certification help?
Complimentary online training for all clients: We offer complimentary nationally recognised training courses for our clients that can be accessed by your entire team – it’s the best way to gain confidence and knowledge, helping your organisation prepare for your certification audit and ensure ongoing compliance.
Partner with us to get your business to higher standards: With 30 years of experience, Citation Certification has partnered with thousands of organisations across New Zealand and Australia on their certification journey, driving continuous improvement.
Lean on us to access our expertise: Feel at ease knowing that our QMS audits team is supportive, friendly, and personable. Our auditors are passionate about high standards, dedicated to helping you conduct internal and external audits, verify conformity, and achieve excellence. They’re locally based and focused on delivering high-quality customer care and valuable feedback. We’re always available to answer any questions you have, including those about documentation and lead auditor training. Contact us here.