An Auditors Insight: What to Expect During an ISO 9001 or AS9100 Audit

Auditor Insights: What to Expect During an ISO 9001 or AS9100 Audit

Achieving ISO 9001 or AS9100 certification is a significant milestone for any manufacturing company. These certifications demonstrate your commitment to quality, consistency, and continuous improvement, opening doors to new business opportunities and solidifying customer trust. However, the road to certification often feels daunting, especially when facing an audit. Understanding what auditors are looking for and preparing your team can turn the experience from nerve-wracking to empowering.

In this blog, we’ll explore what to expect during an ISO 9001 or AS9100 audit and how proper preparation can ensure a smooth process.

Understanding the Different Types of Audits

There are generally two types of audits associated with ISO/AS certification:

1. Internal Audits

Internal audits are conducted by your own team or a third-party consultant to ensure your processes comply with the certification standards. These audits are a practice run to identify non-conformities and fix them before the formal audit.

2. Certification (or External) Audits

This is the formal audit conducted by a third-party certification body. It’s split into two stages:

• Stage 1 Audit (Documentation Review): The auditor evaluates your Quality Management System (QMS) documentation to ensure it aligns with ISO/AS requirements.
• Stage 2 Audit (Implementation Review): The auditor assesses the implementation of your QMS, ensuring the documented processes are followed and effective.

What to Expect During the Audit

1. Opening Meeting

Auditors begin with an opening meeting to explain the audit’s scope, objectives, and methods. This is an opportunity for you to clarify questions and understand the focus areas of the audit.

2. Documentation Review

Auditors will review critical QMS documents, including:

• Quality policy and objectives.
• Process flow diagrams and procedures.
• Risk management and mitigation plans.
• Internal audit and management review records.

They are looking for clear, comprehensive documentation that aligns with ISO/AS standards and your company’s processes.

3. Employee Interviews

Auditors will engage employees at all levels, from management to shop floor workers. They’re assessing whether team members understand their roles within the QMS and can demonstrate compliance with procedures.

Tip: Ensure employees are comfortable speaking about their tasks and how they contribute to quality objectives.

4. Process Observation

Auditors will observe processes in action, comparing what they see to your documented procedures. They are looking for evidence that:

• Procedures are followed consistently.
• Quality checks are conducted at appropriate stages.
• Corrective actions are taken when non-conformities arise.

5. Risk and Improvement Focus

ISO 9001 and AS9100 emphasize risk-based thinking and continuous improvement. Auditors will evaluate:

• How risks are identified, assessed, and mitigated.
• Evidence of ongoing improvement initiatives.

6. Closing Meeting

The audit concludes with a closing meeting where the auditor shares their findings. You’ll receive a report highlighting any non-conformities or areas for improvement. If there are major issues, you’ll need to address them before certification can be granted.

Common Audit Challenges

1. Inadequate Documentation

Insufficiently detailed or poorly maintained records can raise red flags during an audit.

2. Lack of Employee Awareness

If employees can’t articulate their role in the QMS, auditors may question the effectiveness of your system.

3. Non-Conformities

From missed calibration schedules to inconsistent process execution, even minor non-conformities can delay certification.

4. Poor Risk Management

Failing to demonstrate a proactive approach to identifying and managing risks can result in audit findings.

How to Prepare for a Successful Audit

1. Conduct Thorough Internal Audits

Regular internal audits help identify and address gaps before the certification audit.

2. Train Your Team

Ensure all employees understand their roles and how they contribute to the QMS. Provide training to build confidence and alignment with certification requirements.

3. Update Documentation

Maintain up-to-date records of procedures, risk assessments, and improvement actions. Ensure all documentation is easily accessible.

4. Address Non-Conformities Promptly

Act on findings from internal audits or pre-assessment reviews to minimize the risk of non-conformities during the formal audit.

5. Partner with Experts

Bringing in experienced consultants can streamline the preparation process, ensuring nothing is overlooked.

True North Quality: Your Partner for a Guaranteed Certification

At True North Quality, we understand the challenges of navigating ISO 9001 and AS9100 audits. With over 35 years of expertise, we offer a comprehensive, hands-on approach to preparing your manufacturing company for success. Our services include:

• Detailed gap analyses to identify and address deficiencies.
• Customizable QMS templates and documentation tailored to your operations.
• Expert guidance through internal audits and pre-assessments.
• Employee training programs to ensure your team is audit-ready.
• Ongoing support until certification is achieved.

We’re so confident in our process that we guarantee 100% certification success. With True North Quality by your side, you’ll navigate the certification journey with confidence, ensuring your company meets ISO/AS standards and is set up for long-term growth.

Ready to achieve certification without the stress? Contact True North Quality today and schedule your free Game Plan Call.