SPEC Q1 (API) Lead Auditor Course
Course Information
Duration: 5 Days
Designed For
Our SPEC Q1 (API) auditor course is designed to train delegates in the principles and practices of undertaking API Q1 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 – Principles of ISO & API Standards
- Module 3 – Quality Management System Requirements ‐ Section 4
- Module 4 ‐ Quality Management System Requirements ‐ Section 5, Product Realisation
- Module 5 ‐ Section 5: Quality Management System Requirements ‐ Section 5.7, Product and Service Provision
- Module 6 ‐ Section 6: Quality Management System Requirements ‐ Section 5.8 Control of Testing, Monitoring, Measuring, Analysis & Improvement
- Module 7 ‐ Section 6: Quality Management System Requirements ‐ Section 6 QMS Monnitoring, Measuring, Analysis and Improvement.
- Module 8 – Conducting the Audit
- Examination – open book