API Q1 Internal Auditor
Offered via Instructor-Led (4 days)
Develop the expertise to plan and conduct internal audits that ensure API Q1 compliance and improvement
Next Class: 12/09/2025 - Live Stream

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About

The 4-Day API Q1 Internal Auditor training course provides a complete understanding of the API Q1 10th Edition standard and the practical auditing skills needed to assess compliance. The course includes:

  • 3 days of comprehensive training on the API Q1 standard

  • 1 day of practical Internal Auditing Techniques based on ISO 19011:2018

Description

Designed by Mireaux Management Solutions, this course prepares participants to audit API Q1-based Quality Management Systems with confidence and accuracy. As with our implementation course, this class uses our proven 3-prong approach to break down each clause:

  1. What the standard says

  2. How to implement the requirement

  3. How to audit it

The final day is dedicated to developing auditing competencies through hands-on exercises, role-playing scenarios, and real-world audit examples.

Core topics include:

  • API Q1 structure, scope, and background

  • Clause-by-clause explanation of API Q1 10th Edition

  • Key changes from the 9th to 10th Edition

  • The complete Internal Audit process: planning, execution, reporting, and follow-up

Learning Objectives​

By the end of this course, participants will understand:

API Q1 10th Edition:

  • The industry scope and use of API Q1

  • How to identify processes using the Process Approach

  • How to implement and audit each clause of the standard

  • Transition strategies from the 9th Edition or ISO 9001:2015

  • APIQR certification requirements and documentation best practices

Internal Auditing Techniques:

  • The roles and responsibilities of Internal Auditors

  • How to plan, conduct, and report Internal Audits

  • How to interview personnel, observe processes, and review records

  • How to write clear, concise nonconformities and effective audit reports

  • Best practices for following up on audit findings

Prerequisites​

This course does not have formal prerequisites. However, for those with limited experience in Quality Management Systems, we recommend completing:

  • Mireaux’s Fundamentals or Advanced Document Control courses

  • ISO 9001:2015 Implementation or Internal Auditor course

Teaching Methods

Summary Agenda

The topics in this course include:

API Q1 10th Edition

  • Background and History of API Q1
  • Quality Management Principles
  • Structure of API Q1 10th Edition
  • The Process Approach
  • About APIQR Registration and Certification Program
  • Detail review of Clause 4: Quality Management Systems Requirements
    • Quality Management System
    • Management Responsibility
    • Organization Capability
    • Documentation Requirements
    • Control of Records
  • Detail review of Clause 5: Product Realization
    • Contract Review
    • Planning
    • Risk Assessment
    • Design
    • Purchasing
    • Control of Product Realization
    • Product Release
    • Testing, Measuring, Monitoring and Detection Equipment (TMMDE)
    • Control of Nonconforming Product
    • Management of Change (MOC)
  • Detail review of Clause 6: QMS Monitoring, Measurement, Analysis and Improvement
    • General
    • Monitoring, Measuring, and Improving
    • Analysis of Data
    • Improvement
    • Management Review

Internal Auditing Techniques

  • Establishing the Audit Program:
    • Audit Frequency and Schedule
    • Audit Templates
    • Audit Findings
    • Audit Planning
  • Principles of Auditing
  • Auditor Competence
  • Performing the Audit:
    • Preparing the Audit Agenda
    • Preparing Checklists
    • Opening Meeting
    • Audit Interviews
    • Closing Meeting
    • Audit Report

Successful Completion​

Participants’ successful completion of the course is determined by:

  • Active participation
  • Completion of workshops administered at various stages of the class
  • Completion of Implementation and Internal Auditor Tests

Upcoming Classes

DatesDelivery MethodLocationCost (USD)Register
Dec 9 - Dec 12, 2025Live StreamOnline via Microsoft Teams$1,795Add to Cart
Dec 9 - Dec 12, 2025
Live Stream
Location
Online via Microsoft Teams

Self-Paced Online

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