External auditor

Adopted as a national standard by most countries, ISO 9001 is the choice of over a million companies in the vast majority of countries around the world, as the foundation of their quality management systems. It is also a major strategic element in supply chains for goods and services.

This standard serves as the foundation for most sector-specific quality management system (QMS) standards, whether in the automotive, aerospace, medical device or physical laboratory, biomedical or other sectors.

Supplier QMS auditors have an important role to play in qualifying and monitoring suppliers, in addition to or in the absence of third-party certification.

Although focused on supplier auditing, this course is entitled “External Auditor”, as it is also relevant to the auditing of delocalized or decentralized facilities. In such cases, the auditor will be faced with situations that are more akin to external auditing than internal auditing. The planning of this type of audit must take into account factors such as geography, language, culture, etc., which are rarely or rarely encountered in internal audits.

Target clientele

This course is aimed at future auditors who will have to carry out or lead audits of their organization’s suppliers – or third-party suppliers – and at supervisors of suppliers’ QMS, whether certified or not.

Although the course is linked to ISO 9001, the skills acquired are applicable to all types of management systems, such as ISO 14001, ISO 45001, AS9100, etc.

The course provides a solid foundation for new auditors, a useful refresher for auditors with previous experience, and an introduction to the role of lead auditor.

For those aiming to work for a registrar, it’s a good idea to ask the registrar about their specific requirements beyond what is included in this course.

Course objective

This 3-day course on QMS auditing, reflects the requirements of theISO 19011:2018 – Guidelines for auditing management systems – which governs audits of all management systems, whether related to quality, the environment, occupational health and safety, or other areas.

Following a contextualization of the auditor’s role when faced with an ISO 9001:2015-compliant management system, and through discussions on audit situations, the course provides knowledge of the principles and techniques of external supplier auditing.

The course pays particular attention to the process approach and the risk-based approach. To better understand the fundamental approach to auditing, the course also looks at the auditing of undocumented processes.

Content

If an external audit is to provide a proper assessment of an organization’s QMS, it must be carefully planned and prepared. The auditor needs a flexible and effective auditing technique, good communication skills and rigorous documentation and follow-up. These elements are also relevant to the audit program manager.

The course enables participants to rediscover the requirements of ISO 9001:2015 through the auditor’s questions and the ISO principles of quality management.

The course presents proven methods for evaluating a QMS. Practical workshops will guide you step-by-step through the audit process, from audit planning to audit conclusions.

You’ll discover common pitfalls to avoid.

You can also have in-depth discussions with an experienced professional instructor and other participants.

This course, combined with academic prerequisites and appropriate audit experience, will enable you to audit effectively and lead an audit team.

The main aspects covered are :

• ISO principles of quality management
• Auditing ISO 9001 requirements (applicable to other management system standards)
• Interface between audit process and audit program management
• Audit activity inputs
• Review of manual and documentation
• Using checklists
• Trigger the audit and hold opening meetings
• Information gathering
• Audit psychology
• Prepare audit conclusions
• Conducting effective closing meetings
• Audit report
• Corrective action follow-up

Prerequisites

To benefit fully from the course, it is recommended that all participants have a good prior knowledge of ISO 9001, or some familiarity gained through experience, with this standard or any other management system standard developed in, or consistent with, ISO 9001.

Total time

The course is spread over 3 days of 7 hours’ training each, generally from 8:30 a.m. to 4:30 p.m.
For in-house sessions, this schedule can be adjusted to suit the organization’s preferences.

Evaluation

A written exam is available at the end of the session. This review covers ISO quality management principles, their application to ISO 9001:2015 or other relevant standards, and the requirements of ISO 19011:2018. It also covers verbal and written communication skills.

• On-site examinations must be arranged with the session manager.
• In public sessions, the exam is optional.

Rates

• 1 725 $ / participant in virtual class
• 1 875 $ / participant in classroom
• Request a quote for a private group session