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ISO 9001:2015 Basic Principles

ISO 9001-2015 Requirement: What are the major elements of ISO 9001 2015, and why they are important.

Primary Section(s): 0.1, 0.2, 0.3, 0.4

Secondary Section(s): 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, A.1, A.4, Annex B,

Key Requirements:

Implementation Tools:


Section 0.1: General and Section 0.2 Quality Management Principles

This section outlines the major tenants of the ISO series approach to quality management touching on key issues such as satisfying customer requirements, leadership’s critical role in quality assurance, process-based quality management and employing known measurements and principles. While ISO 9001 2015 builds upon its predecessors (ISO 9001 2008, ISO 9001 2000, etc.), it provides some key expansions that greatly change how it is implemented including:

    • Elevation of responsibility for the quality management function to the highest level of an organization’s management, and the need for top managers to be ensure that a process-based quality management function is aligned with the organization’s goals, strategy and tactics.
    • A continued, but more powerful emphasis on ways to increase and maintaincustomer satisfaction, including supporting the customer’s regulatory environment and providing a constantly improving customer experience*

Introduction to ISO 9001 PowerPoint Reviews each section of the standard

Section 0.3 and 0.4: Process Approach

This section includes and emphasis on using a controlled approach for optimizing results in the traditional PDCA methodology. It also makes risk evaluation/management an explicit part of the quality planning and implementation process that anticipates problems from ongoing operations -and risks from embarking upon new endeavors (including its application to groups that may impact an organization such as suppliers, employees, distributors, local/national governments, etc.)

It also creates a means for better conformity to other ISO management standards (such as ISO 14001 or AS9100) through adherence to a common structure, content and terminology, making implementation of multiple (or integrated) ISO standardseasier.

Continued emphasis on using an organization-wide process approach for managing quality (see Principle 3: Involvement of People), but with greater emphasis on:

* A focus on customer satisfaction permeates all aspects of quality management to include many organizational types (essentially a broader definition of what is a “business” to include non-profits, non-governmental entities, etc.), employing a continuous improvement effort to customer satisfaction metrics, using customer requirements as key goals in the QMS, using a risk-based evaluation process in seeking to deliver customer satisfaction and more.

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