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SPEC Q2 (API) Lead Auditor Course

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Course Information

Duration: 5 Days


Designed For

Our SPEC Q2 (API) lead auditor course is designed to train delegates in the principles and practices of undertaking API Q2 quality management system audits. These are in line with the generic guidelines laid down in ISO 19011 and the requirements of the ISO EN 17021 standard.

Participants will also learn the skills and techniques of auditing and how to communicate the findings of the audit effectively to the management of the audited organisation. On completion of the course, delegates should also understand the principles of accreditation and certification schemes.


Course Content

This course is designed to provide delegates with the knowledge needed to audit and improve quality management systems. The course comprises a mix of lectures and practical exercises including role‐play and case studies to provide the delegates with a full understanding of the quality audit process. The practical exercises focus on the audit process using the ISO and API series of standards.
• Module 1 ‐ Introduction to Auditing
• Module 2 – Importance of API Q2 to Industry, Business Drivers and Industry Response
• Module 3 ‐ Principles of ISO & API Standards
• Module 4 – Quality Management System Requirements – Scope, Exclusions and Section 4
• Module 5 ‐ Quality Management System Requirements ‐ Section 5, Realisation of Service
and Service Related Product
• Module 6 ‐ Section 5: Quality Management System Requirements ‐ Section 6,
Measurement, Analysis and Improvement
• Module 7 – Conducting the Audit
• Examination – open book

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