ISO 9001:2015 Clause 6.3, titled "Planning of Changes," pertains to the management of changes within the quality management system (QMS) of an organization. This clause focuses on ensuring that changes are carried out in a structured and controlled manner to prevent adverse impacts on the QMS's effectiveness and the organization's ability to meet its quality objectives.
What this Clause 6.3 Means in More Detail
Need for Change: The organization must identify and determine the need for changes in its QMS. Changes could be driven by various factors such as evolving customer requirements, technological advancements, regulatory updates, or internal process improvements.
Planning: Changes should be carefully planned, documented, and executed following a systematic approach. The planning process should consider the scope and implications of the proposed changes.
Consideration of Consequences: When planning changes, the organization should evaluate the purpose of the change and its potential consequences. This means understanding why the change is necessary and what impacts it may have on processes, products, and services.
Maintaining QMS Integrity: The organization must ensure that changes do not compromise the integrity of the QMS. This involves verifying that the fundamental principles and structure of the QMS remain intact and that the QMS continues to meet its intended goals.
Resource Availability: The organization should assess the availability of resources required for implementing the changes. Resources may include personnel, equipment, technology, and financial resources. Adequate resources are essential to execute the changes effectively.
Responsibilities and Authorities: Changes may necessitate the allocation or reallocation of responsibilities and authorities. The organization should review and adjust roles and responsibilities as needed to support the changes.
In essence, Clause 6.3 emphasizes that any changes to the QMS should be well thought out, planned, and executed in a manner that ensures the QMS's continued effectiveness. It's about managing change in a way that minimizes disruption and maximizes the organization's ability to meet its quality objectives. By adhering to this clause, organizations can maintain control over the evolution of their QMS and keep it aligned with their strategic goals and the needs of their customers.
ISO 9001:2015 Clause 6.3 Requirements for Managing QMS Changes
The key elements of this clause are as follows:
Purpose and Consequences (6.3a): When contemplating changes to the QMS, the organization must consider the purpose of the change and its potential consequences. This involves clearly defining why the change is necessary and what impact it may have on the organization, its processes, and its ability to meet quality objectives. The purpose and consequences should be well-understood before implementing the change.
Integrity of the Quality Management System (6.3b): The organization must ensure that any proposed changes do not compromise the integrity of the QMS. This means that changes should not negatively affect the organization's ability to maintain and improve the effectiveness of its QMS, deliver conforming products and services, and enhance customer satisfaction. The QMS's core principles and structure should remain intact.
Availability of Resources (6.3c): Before implementing changes, the organization should assess whether it has the necessary resources (including personnel, materials, equipment, and financial resources) to support the change. This ensures that the change can be carried out effectively without straining the organization's capacity.
Allocation or Reallocation of Responsibilities and Authorities (6.3d): Changes to the QMS may involve adjustments to roles and responsibilities within the organization. The organization must consider whether any allocation or reallocation of responsibilities and authorities is necessary to support the change. It's crucial to ensure that individuals or teams responsible for specific QMS activities are aligned with the new requirements.
ISO 9001:2015 Clause 6.3 Planning of change
In summary, this clause emphasizes that changes to the QMS should not be haphazard but carefully planned and executed. Organizations should thoroughly assess the need for change, evaluate its potential consequences, and ensure that the integrity of the QMS is maintained.
Adequate resources should be available, and responsibilities and authorities may need adjustment to support the change effectively. By addressing these considerations, the organization can manage change in a controlled and systematic manner, which is essential for maintaining the effectiveness of the QMS and achieving quality objectives.