Deutsch: Umfang / Español: Alcance / Português: Escopo / Français: Portée / Italiano: Ambito
Scope in the quality management context refers to the boundaries and extent of the activities, processes, products, services, and objectives covered by a Quality Management System (QMS). It defines what is included within the system, setting clear parameters for where quality standards, policies, and procedures apply. The scope is critical for establishing the range of operations, specifying applicable exclusions, and identifying the responsibilities within the organization's quality management efforts. It serves as a foundation for planning, implementing, maintaining, and improving quality across all relevant areas of the organization.
General
The scope is documented in the quality manual or similar QMS documentation and is essential for certification processes, such as ISO 9001. It helps all stakeholders understand the extent of the organization's commitment to quality, ensuring that the QMS is appropriately designed to meet the organization's specific needs, challenges, and goals.
Description
In quality management, the scope typically includes:
- Products and Services: The specific products or services to which the QMS applies.
- Processes: The key processes involved in delivering these products or services, from design and development to delivery and post-delivery support.
- Locations: Physical or virtual locations where the QMS is applied.
- Departments and Functions: Organizational units included in the QMS.
Application Areas
- Manufacturing: Defines the products manufactured, the processes involved, and the manufacturing locations covered by the QMS.
- Service Industries: Specifies the range of services provided, the processes for service delivery, and the customer segments served.
- Software Development: Outlines the software products developed, the development lifecycle processes, and the support services included.
Examples
- A manufacturing company's QMS scope may cover all processes related to the design, production, and delivery of specific product lines but exclude contracted services such as cleaning and maintenance.
- A hospital's QMS scope might include all patient care services, support services (e.g., laboratory, radiology), and administrative processes, specifying any outsourced activities not covered by the system.
Risks
A poorly defined scope can lead to confusion about the responsibilities and expectations for quality, potentially leading to gaps in the QMS and non-conformities with quality standards. It can also result in inefficiencies and a QMS that is either too narrow, missing critical areas, or too broad, becoming unwieldy and difficult to manage.
Summary
The scope in the quality management context is a fundamental aspect that defines the range of products, services, processes, and organizational units included in a Quality Management System. It provides clarity on what the QMS covers, guiding the development and implementation of quality policies and procedures to ensure they are relevant and effective. Properly defining the scope is crucial for achieving quality objectives, meeting customer and regulatory requirements, and facilitating continuous improvement.
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