ISO 9001 and Quality Auditing: What CQE Candidates Need to Know
Quality systems and auditing form a full section of the CQE Body of Knowledge. Here is what ISO 9001 requires and how audits actually work.
Statistical tools improve individual processes, but it is the quality management system that holds everything together—and auditing is how organizations verify the system is actually working. Together they make up a full section of the CQE Body of Knowledge devoted to quality system development, implementation, and verification.
I am John Lee of Alpha Training and Consulting. Here is a CQE-focused overview of ISO 9001 and the auditing practices that keep quality systems honest.
What ISO 9001 requires
ISO 9001 is the world’s most widely adopted quality management standard. It does not tell you how to make your product; it defines requirements for the system that ensures your product consistently meets customer and regulatory expectations. Two ideas run through the current standard: the process approach, which treats the organization as interlinked processes with inputs and outputs, and risk-based thinking, which asks organizations to identify and address risks and opportunities proactively.
- Leadership commitment and a clear quality policy.
- Documented processes and control of documents and records.
- Management of resources, competence, and infrastructure.
- Monitoring, measurement, internal audit, and management review.
- Continual improvement driven by data and corrective action.
The three types of audit
| Type | Who performs it | Purpose |
|---|---|---|
| First-party (internal) | The organization on itself | Self-assessment and improvement |
| Second-party | A customer on its supplier | Evaluate and qualify a supplier |
| Third-party | An independent registrar | Certification to a standard such as ISO 9001 |
How an audit is conducted
- 1Planning: define scope, objectives, and criteria, and select the audit team.
- 2Preparation: review documents and build checklists tied to requirements.
- 3Execution: gather objective evidence through interviews, observation, and records.
- 4Reporting: document conformities and nonconformities against specific requirements.
- 5Follow-up: verify that corrective actions addressed the root cause and were effective.
The quality engineer’s role
Quality engineers are often trained internal auditors, and the CQE expects you to understand both sides of the table—how to conduct an audit and how to respond to findings with effective corrective action. Auditing also connects to the economics of quality: a strong system reduces failure costs, which links back to the Cost of Quality framework at the heart of quality management.
Frequently asked questions
What is ISO 9001?+
ISO 9001 is the internationally recognized standard for a quality management system. It sets requirements for how an organization plans, controls, and improves its processes to consistently meet customer and regulatory requirements.
What are the three parties in auditing?+
First-party audits are internal, conducted by the organization on itself. Second-party audits are conducted by a customer on a supplier. Third-party audits are conducted by an independent registrar for certification.
What makes a valid audit finding?+
A finding must rest on objective evidence—records, observations, or statements that can be verified—and must reference a specific requirement of the standard or the organization’s own procedures. Auditors report facts, not opinions.
Written by
John Lee
President, Alpha Training and Consulting
John Lee has more than 25 years of experience in quality engineering and has personally earned every ASQ certification, including the Certified Quality Engineer (CQE). A Shingo Award–winning author, he has helped thousands of engineers pass their ASQ exams on the first attempt with a 94% first-time pass rate.
Certifications: BSME, MBA, CMQ/OE, CQE, CRE, CQA, CQIA, CQI, CCT, CQPA, CQT, CHA, CBA, CSQE, CSQP, CCQM, CSSYB, CSSGB, CSSBB, CPGP, CMBB
Alpha Training and Consulting is an independent training provider and is not affiliated with, endorsed by, or sponsored by ASQ. "ASQ" and "Certified Quality Engineer (CQE)" are trademarks of the American Society for Quality. Exam policies, fees, and Body of Knowledge weightings are set by ASQ and can change—always confirm current details at asq.org.