In today’s competitive manufacturing environment, maintaining high quality standards is essential. That’s where Quality Management System (QMS) audits come into play. Whether you’re aiming to get certified, maintain compliance, or improve internal processes, understanding how QMS audits work, and how to prepare for them, can make the difference between a smooth pass and a stressful scramble. In this post, we’ll walk you through what QMS audits are, the types you might face, what to expect and how to prepare for success.
What is a QMS Audit?
A QMS audit is a systematic and independent examination of a company’s quality management system to determine whether activities and results comply with planned arrangements and whether these arrangements are effectively implemented and maintained.
These audits are crucial for ensuring compliance with industry standards such as ISO 9001, improving operational efficiency and building customer trust through consistent product and service quality.
Types of QMS Audits
There are several types of QMS audits, each with its own purpose and timing:
1. Internal Audit:
Also known as a first-party audit, this is conducted by or on behalf of the organisation itself to check compliance and identify areas for improvement. It’s a proactive tool for preparing for external audits and enhancing quality control.
2. External Audit:
Also called a second- or third-party audit, this is conducted by an outside body:
- Second-party audits are usually conducted by customers.
- Third-party audits are performed by independent certification bodies for certification or surveillance purposes.
3. Surveillance vs. Recertification Audits:
Surveillance audits are periodic checks (usually annually) done by the certifying body to ensure your QMS continues to meet the standards. Recertification audits occur every few years and are more comprehensive, reassessing the entire QMS for renewal of certification.
What to Expect During a QMS Audit
During a QMS audit, auditors typically conduct a thorough review of documentation, including quality manuals, standard operating procedures (SOPs) and records, to ensure they align with both internal requirements and external standards. They will also interview employees to assess their understanding of the company’s processes and policies, and observe operational activities in real time to confirm that procedures are being followed as documented.
Suggested Read – Key Differences between Audit and Inspection
Throughout the audit, auditors look for any non-conformities or areas where the system can be improved. The process usually involves a mix of desk-based reviews, facility walkthroughs and open dialogue with staff. It’s important to remember that the audit is generally a collaborative exercise, auditors are there to verify compliance and help strengthen your quality management system, not to assign blame.
Common Challenges Companies Face
Many companies face similar obstacles during a QMS audit:
- Inadequate documentation or outdated procedures
- Lack of employee awareness of QMS policies and processes
- Poor record-keeping, especially in areas like training, calibration, or supplier performance
- Failure to act on previous audit findings
- Over-reliance on a single person to manage the entire QMS
These issues can be avoided with strong internal controls and a culture that embraces quality as everyone’s responsibility.
Preparation Tips for a Successful Quality Management Audit
Here’s how you can set yourself up for audit success:
Conduct Regular Internal Audits
Internal audits are your first line of defence when it comes to QMS compliance. Think of them as a dress rehearsal for the main event. Regular internal audits help identify issues before they escalate and ensure that processes are being followed as documented. They also reinforce a culture of continuous improvement and keep your team audit-ready at all times. Use them to simulate external audits as closely as possible, complete with documentation reviews and process observations.
Keep Documentation Up to Date
Outdated or inconsistent documentation is one of the most common causes of non-conformities. Make sure your quality manuals, SOPs, work instructions, checklists and forms accurately reflect current practices. Review them periodically and involve the people who actually perform the tasks to ensure what’s written aligns with what’s done. Also, version control and proper approvals are essential. Auditors will check that the right documents are being used at the right time.
Train Your Team
Your employees are a key part of the audit process. Auditors will often ask team members questions about procedures, responsibilities and quality objectives. To prepare, conduct regular training sessions and refreshers on your QMS policies, audit procedures and each team member’s role in maintaining quality. Make sure they understand the “why” behind the processes, not just the “how”. A confident, knowledgeable team reflects well on your company’s commitment to quality.
Review Previous Audit Findings
One of the first things an auditor will check is whether you’ve addressed any issues raised during past audits. This shows that your organisation is committed to corrective action and continuous improvement. Go through previous audit reports, ensure that corrective actions were properly implemented and verify that they were effective. Keep records of your follow-up actions, including timelines, responsible persons, and outcomes. These demonstrate accountability and progress.
Do a Pre-audit Gap Analysis
A gap analysis is a proactive way to assess your current QMS performance against the applicable standards or audit criteria. This allows you to identify any weak areas or non-compliance before the official audit begins. Use checklists and, if possible, involve someone external or unfamiliar with your processes for a more objective review. The goal is to close gaps early and reduce the risk of surprises during the actual audit.
Be Transparent
Auditors appreciate openness and honesty. If there’s a known issue in your system, don’t try to hide it. Instead, show that you’ve acknowledged it and are taking steps to address it. Being transparent builds credibility and demonstrates a genuine commitment to quality and compliance. Most auditors will value a company that is actively improving more than one that appears perfect but uncooperative.
QMS Audit Checklist
Use this high-level checklist to ensure you’re ready and customise it to suit your specific standards (e.g., ISO 9001, AS9100, IATF 16949).
- Quality Manual is current and approved
- Procedures and SOPs are accessible and followed
- Records are complete, legible and retained per requirements
- Internal audits and management reviews are conducted regularly
- Corrective and preventive actions are documented and tracked
- Training records are up to date
- Calibration records for equipment are available
- Supplier evaluations and approvals are documented
- Risk assessments are available (if required)
- Employees understand their role in the QMS
QMS audits don’t need to be intimidating. With the right mindset, preparation and ongoing commitment to quality, they can serve as a valuable tool for business improvement, not just a box to check for certification. By understanding the audit process and proactively addressing common pitfalls, your organisation can pass with confidence and continue delivering high-quality results to your customers.
Need help preparing for your next QMS audit? At Global Inspecting Management our inspection experts are here to guide you through every step of the process, from internal audits to full compliance consulting. Contact us today to learn how we can support your quality goals.