ISO 9001:2015 is structured into ten clauses, each addressing specific aspects of a quality

management system (QMS). Here's a detailed outline of the standard by clause:

Clause 1: Scope

● Purpose: Defines the scope of the standard, stating that it specifies requirements for
a QMS that can be used by an organization to demonstrate its ability to consistently
provide products and services that meet customer and applicable statutory and
regulatory requirements.
● Key Points: Clarifies that the standard is applicable to organizations regardless of
size, type, or product/service provided.

Clause 2: Normative References

● Purpose: Lists any references to other standards that are essential for the
application of ISO 9001:2015.
● Key Points: Specifies which editions of referenced documents are applicable.

Clause 3: Terms and Definitions

● Purpose: Provides definitions of key terms used throughout the standard to ensure
consistent interpretation and understanding.
● Key Points: Includes definitions critical to understanding the requirements and intent
of the standard.

Clause 4: Context of the Organization

● Purpose: Requires the organization to determine the external and internal issues
that are relevant to its purpose and that affect its ability to achieve the intended
outcomes of its QMS.
● Key Points: Emphasizes understanding the organization and its context to define the
scope of the QMS and to determine risks and opportunities.

Clause 5: Leadership

● Purpose: Establishes leadership and commitment within the organization regarding

the QMS.
● Key Points: Requires top management to demonstrate leadership and commitment
by establishing policies, ensuring integration of the QMS into business processes,
and promoting continual improvement.

Clause 6: Planning

● Purpose: Requires the organization to plan actions to address risks and

opportunities and to integrate them into the QMS processes.
● Key Points: Includes requirements for quality objectives, planning to achieve them,
and planning for changes.
Clause 7: Support

● Purpose: Provides requirements to support the operation of processes within the

QMS.
● Key Points: Covers resources, competence, awareness, communication,
documented information (formerly documentation requirements), and control of
documented information.

Clause 8: Operation

● Purpose: Specifies requirements for planning and controlling the processes related
to the organization's products and services.
● Key Points: Includes requirements for planning and controlling operational
processes, determining requirements for products and services, and controlling the
provision of products and services.

Clause 9: Performance Evaluation

● Purpose: Requires the organization to monitor, measure, analyze, and evaluate

performance of the QMS.
● Key Points: Includes requirements for monitoring and measuring, customer
satisfaction, internal audits, management review, and determining what needs to be
monitored and measured.

Clause 10: Improvement

● Purpose: Emphasizes the need for continual improvement of the QMS.

● Key Points: Includes requirements for nonconformity and corrective action, continual
improvement, and addressing risks and opportunities.

Additional Considerations:

● Process Approach: ISO 9001:2015 emphasizes a process approach to managing

the QMS, focusing on understanding and managing interrelated processes as a
system.
● Risk-Based Thinking: The standard incorporates risk-based thinking throughout,
requiring organizations to consider risks and opportunities in planning and
implementing the QMS.
● Context of the Organization: Understanding the external and internal context of the
organization is essential for determining the scope of the QMS and its processes.

Implementing ISO 9001:2015 involves aligning organizational processes with these clauses
to achieve consistency in product/service quality, customer satisfaction, and continual
improvement. Each clause provides a framework for establishing, implementing,
maintaining, and improving a QMS tailored to an organization's needs and objectives.