This is an overview of each clause of ISO 9001:2015 explained and how it is organized into clauses that define the requirements for a quality management system. Its structure consists of ten clauses, each focusing on specific aspects of a quality management system (QMS) and arranged using the PDCA process approach.
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 standard’s scope, specifying the boundaries and applicability of the quality management system (QMS). It outlines what parts of the organization are covered by ISO 9001 and which processes are not.
Clause 2: Normative References
Any references to external documents (standards, regulations) essential for applying ISO 9001 are listed here.
Clause 3: Terms and Definitions
This clause defines key terms used throughout the standard to ensure a common understanding.
Auditable Clauses of the ISO 9001:2015 Standard: “PLAN” Clauses
Clauses 4, 5, 6, and 7 represent the first auditable clauses. These are “Plan” clauses, the first step in the process approach defined as Plan, Do, Check, Act.
Clause 4: Context of the Organization
This crucial clause requires organizations to determine the internal and external issues affecting their purpose and strategic direction. Organizations must also 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, and responsibilities, and ensuring available resources.
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 the resources, competence, awareness, communication, and documented information needed for the quality management system to be effective.
ISO 9001:2015 Standard “DO” Clause
Clause 8 concerns Operations, which generates a lot of data. Since the “DO” clause concerns data, clause 8 has the most documented information. It also contains the core processes in ISO: scheduling, order taking, design and development, purchasing, production, shipping, and quality control (nonconformances).
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, measuring, analyzing, and evaluating the QMS, including internal audits, management reviews, and customer satisfaction monitoring.
ISO 9001:2015 Standard “ACT” Clause
Clause 10 is the primary “Act” clause, where action is taken after “checking” the QMS. Actions include corrective action, taking action on risks and opportunities (preventive action), or 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 apply to any organization, regardless of its size or the nature of its products and services. Remember that the specifics of ISO 9001 may evolve, so it’s essential to refer to the latest standard version for the most accurate information.
