Clause 4.3 of ISO 9001:2015 is part of the standard's Section 4, which deals with the "Context of the Organization." This clause, titled "Determining the Scope of the Quality Management System," focuses on defining the boundaries and extent of the quality management system (QMS) within the organization. It is a fundamental step in establishing and documenting the QMS, as it clarifies the purpose and applicability of the system.
Here's what ISO 9001 Clause 4.3 means
Defining the QMS Scope: The organization needs to define the scope of its QMS. This means specifying which parts of the organization, which processes, and which functions will be included in the QMS. The scope should be documented and communicated within the organization.
Understanding External and Internal Factors: To determine the scope, the organization must take into account the external and internal issues referred to in Clause 4.1 of ISO 9001 that can affect its ability to achieve the intended outcomes of the QMS. These factors can include the organization's size, industry, regulatory requirements, and the expectations of interested parties.
The Boundaries of the QMS: The scope defines the boundaries of what is and isn't covered by the QMS. It may exclude certain processes or functions if they are not deemed relevant to the organization's quality management or if they are outsourced to external parties.
Alignment with the Organization's Purpose: The QMS scope should align with the organization's purpose (products or services it provides) and the results it intends to achieve. It should also align with it's interested parties (customers, employees, stakeholders, etc.) requirements determined in clause 4.2 of ISO 9001.
Documentation and Communication: The scope of the QMS should be documented, and this documented information should be maintained and communicated to relevant stakeholders, both within and outside the organization.
Flexibility for Change: The scope is not fixed and can be adjusted as the organization's circumstances change. It's important to review and, if necessary, revise the scope to ensure it remains appropriate for the organization's objectives.
Scope Statement: It's common for organizations to create a formal scope statement that outlines the boundaries, objectives, and applicable processes of the QMS. This statement provides a clear and concise description of what the QMS encompasses.
Justification or Exclusions to Scope
ISO 9001 allows organizations to exclude certain requirements of the standard from the scope of their QMS under specific conditions. However, these exclusions must be justified and documented. Justification for exclusions typically arises when requirements are not applicable to the organization's processes or when they fall outside the scope of the QMS.
Some key points regarding justifications for exclusions include:
Not Applicable Requirements: If certain requirements of ISO 9001 are not relevant to the organization's operations, products, or services, they can be excluded. For example, if a requirement applies to service organizations but not manufacturing, a manufacturing company can justify the exclusion of that requirement.
Outsourced Processes: If an organization outsources a process or function, it can exclude the corresponding requirements from its QMS. However, the organization remains responsible for ensuring the quality of outsourced processes.
Legal or Regulatory Exemptions: In some cases, legal or regulatory requirements might conflict with ISO 9001. In such instances, an organization can exclude ISO 9001 requirements that cannot be reconciled with legal obligations.
Justification Documentation: To justify an exclusion, the organization must provide documented evidence of why a specific requirement is not applicable and why it is in the best interest of the organization to exclude it.
Justification or exclusions to the scope of the Quality Management System (QMS) in ISO 9001 are important considerations that organizations must address when defining the scope of their QMS. The standard provides guidelines on how and when justifications or exclusions can be made.
Scope Statement: When defining the scope of the QMS, organizations often include a statement that specifies the boundaries of the system and may detail any justified exclusions. This scope statement serves as a clear and concise description of what is included and what is excluded within the QMS.
Implications of Exclusions: Organizations must understand that exclusions should not affect their ability to provide products or services that meet customer requirements or statutory and regulatory requirements. They are still responsible for ensuring quality, even in areas that are excluded from the QMS.
Maintaining Customer Confidence: While exclusions are allowed under ISO 9001, organizations should be cautious when considering them. Excessive or unjustified exclusions can erode customer confidence, and organizations should aim to have the broadest possible QMS coverage while still ensuring effectiveness.
External Auditing: During external audits, certification bodies will review and evaluate the justification for any exclusions. If the justification is deemed valid, the certification may proceed. However, if the justification is insufficient or unjustified, it could lead to non-conformities.
ISO 9001 allows organizations to justify
and make exclusions from the QMS requirements, but this should be done cautiously, with proper documentation and clear justification. The primary aim of exclusions is to ensure that the QMS remains relevant and applicable to the organization's specific context and processes while maintaining a commitment to quality.
ISO 9001 Clause 4.3 Define & Document the QMS Scope
ISO 9001 Clause 4.3 is about defining and documenting the scope of the QMS, including the processes, functions, and boundaries that will be covered by the system. The scope should be aligned with the organization's context and purpose and should consider both internal and external factors. It's a fundamental step in building a quality management system that is both effective and relevant to the organization's goals and circumstances.