Clause 1 of the ISO 9001:2015 standard is titled "Scope." This introductory section outlines the general scope of the standard, specifying the purpose and application of ISO 9001 within the context of a quality management system (QMS). The key points covered in this clause include:
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General Purpose: The clause begins by defining the general purpose of the standard, which is to specify requirements for a quality management system. Organizations use the standard to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements and to enhance customer satisfaction through effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
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Applicability: It states that the standard is applicable to any organization, regardless of its type or size, or the products and services it provides. This universality is a key feature of ISO 9001, making it applicable to a wide range of organizations from manufacturing to service sectors, including both for-profit and non-profit organizations, public and private companies.
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Exclusions: The clause also addresses the subject of exclusions. It specifies that requirements within the standard that cannot be applied due to the nature of an organization and its product can be considered for exclusion. However, exclusions are limited to the requirements within Section 7 (Support) and cannot affect the organization's ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction. The most common exclusions are Product Design and after sale service provision.
The "Scope" clause sets the foundation for the rest of the standard, clarifying its intent, breadth of application, and the framework for its use. It emphasizes the standard's flexibility and its focus on quality management principles that can be universally applied to improve organizational performance and customer satisfaction. This introductory clause is critical for understanding the intent and applicability of ISO 9001, ensuring that organizations can effectively implement its requirements regardless of their specific industry or sector.