Being recognized as an individual who has demonstrated a clear understanding of the ISO 9001:2015 family of standards, rather than just someone who claims to be conversant with "ISO 9000" adds to the credibility of the individual, the organization with which the individual is associated, and of the standards themselves.

Many of the criticisms that have been leveled against previous versions of the ISO 9001 standard have arisen due to a general lack of understanding as to what the standards require and what they aim to achieve, coupled with a number of flawed approaches to the implementation and assessment of ISO 9001- based quality management systems.

Typical flaws have included:

• Excessive focus on written procedures
• Lack of understanding of the organization's processes
• Lack of focus on the customer's needs and expectations
• Systems written and imposed by Quality Managers with no real top management commitment
• "Off-the-shelf" systems implemented with little or no understanding of the organization's processes
• Focus on certification as an end in itself

With the introduction of the ISO 9001:2015 QMS standard, a new and more business-oriented approach has been adopted in the way an organization must operate its quality management system. The focus is no longer on requiring written procedures for all activities and insisting on formal records as evidence, but on the determination of the context of the organization, the needs and expectations of the interested parties, and the risks and opportunities, and for the organization to have clearly defined processes that are managed in order to produce the planned results.

This change in approach requires a corresponding change in "mind-set" for many quality practitioners, if the integrity and credibility of the ISO 9001 standard and the certification process is to be maintained and improved.

Individuals may demonstrate their understanding of the concepts, terminology, requirements and guidance provided by the ISO 9001:2015 standard using the ISTO Certificate of TEST OF UNDERSTANDING or the TEST OF FUNDAMENTALS.

Candidates will be expected to be able to demonstrate their understanding of the following topics:

1. The principles, vocabulary, terms and definitions used in the ISO 9001 and ISO 9000:2015.
2. The requirements for a Quality Management System (QMS), as specified in ISO 9001:2015 ("Quality management systems - Requirements"), applied to organizations of different types, sizes and complexities.
3. The guidance presented in Annex A to ISO 9001:2015, and its role in the implementation of a QMS

1. The principles, vocabulary, terms and definitions used in the ISO 9001 and ISO 9000:2015.
2. The requirements for a Quality Management System (QMS), as specified in ISO 9001:2015 ("Quality management systems - Requirements"), applied to organizations of different types, sizes and complexities.