ISO 9001:2015 is organized into several clauses that define the requirements for a quality management system. ISO 9001:2015 has a structure consisting of ten clauses. Each clause focuses on specific aspects of a quality management system (QMS) and are arranged using the PDCA process approach.
Overview of Each Clause of ISO 9001:2015
Introduction to the ISO 9001:2015 Standard
The first three clauses introduce the ISO 9001 standard and set the foundation with a scope, normative references, and terms and definitions used. Additional terms and definitions can be found in the ISO 9000 glossary.
Clause 1 Scope
This clause defines the scope of the standard, specifying the boundaries and applicability of the quality management system (QMS). It outlines what parts of the organization and which processes are covered by ISO 9001.
Clause 2: Normative References
Any references to external documents (standards, regulations) that are essential for the application of ISO 9001are listed here.
Clause 3: Terms and Definitions
This clause provides definitions for key terms used throughout the standard to ensure a common understanding.
Auditable Clauses of the ISO 9001:2015 Standard: "PLAN" Clauses
Clause 4, 5, 6, and 7 represent the first of the auditable clauses. These are "Plan" clauses, which is the first step in the process approach defined as Plan, Do, Check, Act.
Clause 4: Context of the Organization
This is a crucial clause that requires organizations to determine the internal and external issues that can affect their purpose and strategic direction. Organizations are also required to identify the needs and expectations of their interested parties (customers, employees, suppliers, etc.). This information is used to establish the scope of the quality management system and set its objectives.
Clause 5: Leadership
Leadership sets the tone for the quality management system. It includes the organization's commitment to quality, establishing policies, roles, responsibilities, and ensuring resources are available.
Clause 6: Planning
This involves actions to address risks and opportunities, establishing quality objectives, and planning changes to the quality management system.
Clause 7: Support
Support includes resources, competence, awareness, communication, and documented information needed for the effectiveness of the quality management system.
ISO 9001:2015 Standard "DO" Clause
Clause 8: Operation
This covers the planning and control of the processes needed to meet product or service requirements.
ISO 9001:2015 Standard "CHECK" Clause
Clause 9 represents the checks on the system performed by Monitoring and Measuring QMS results, Internal Auditing, and Management Reviews.
Clause 9: Performance Evaluation
This involves monitoring, measurement, analysis, and evaluation of the QMS, including internal audits, management reviews, and monitoring customer satisfaction.
ISO 9001:2015 Standard "ACT" Clause
Clause 10 is the primary "Act" clause, where action is taken as a result of "checking" the QMS. Actions include corrective action, acting on risk and opportunites (preventive action), or just initiating improvements.
Clause 10: Improvement
This covers nonconformity and corrective action, as well as continual improvement.
Clauses of ISO 9001:2015 Explained
Each clause contributes to establishing a robust quality management system within an organization. The standard is designed to be applicable to any organization, regardless of its size or the nature of its products and services. Keep in mind that the specifics of ISO 9001 may evolve, so it's essential to refer to the latest version of the standard for the most accurate information.