About:
The Certified Quality Auditor (CQA®) certification is a prestigious credential awarded to professionals who specialize in evaluating quality systems and processes, ensuring they adhere to industry standards and regulations. A CQA® plays a vital role in identifying areas for improvement, enhancing organizational efficiency, and ensuring compliance with applicable quality systems. This certification is an industry-recognized mark of expertise in auditing, quality assurance, and continuous process improvement.
Certification body: American Society for Quality (ASQ®)
Learning Objective:
The CQA certification is designed to equip professionals with the knowledge and skills to:
- Evaluate and analyze quality systems using established auditing principles and techniques.
- Conduct thorough audits and produce comprehensive audit reports.
- Identify deficiencies and areas for improvement within an organization’s quality systems.
- Apply critical thinking skills in analyzing case studies and audit scenarios.
Understand and manage the audit process, including audit program management and business applications.
Exam information:
- 150 multiple-choice questions (15 unscored)
- Topics include auditing fundamentals and quality tools
- Available in computer-based and paper-pencil formats
- Computer Exam: 165 questions, 5 hours 18 minutes
- Paper Exam: 150 questions, 5 hours
- Open-book exam (candidates must bring their own reference materials)
- Case studies account for 10-15% of the test
Re certification:
- Recertify every 3 years
- Ensures up-to-date knowledge of industry standards
- Maintains proficiency in quality auditing best practices
Eligibility:
- 8 years of on-the-job experience in Certified Quality Auditor areas
- 3 years in a decision-making role
- Full-time, paid professional experience required
- Educational qualifications may waive part of experience:
- Technical/trade diploma: 1 year waived
- Associate degree: 2 years waived
- Bachelor’s degree: 4 years waived
- Master’s/Doctorate: 5 years waived
Target Audience:
The CQA certification is ideal for:
- Pharmaceutical quality auditors and compliance professionals
- Regulatory affairs specialists
- Quality assurance managers and consultants
- Manufacturing professionals in GMP environments
- Those seeking career advancement in pharmaceutical and quality management sectors
Curriculum:
- The CQA curriculum covers the following key areas:
- Auditing Fundamentals
- Audit Process
- Auditor Competencies
- Audit Program Management and Business Applications
- Quality Tools and Techniques
