Here again is a term that isn’t always well understood.

To assess whether your current quality management system (QMS) meets the requirements of ISO 9001 section 4.3, you’ll need to evaluate if you have clearly defined and documented the scope of your QMS. This scope establishes the boundaries of your quality efforts and ensures that relevant requirements are appropriately applied. Here’s what to examine to determine if you are meeting this requirement.

1. Defining the Boundaries and Applicability of the QMS:

Start by checking if you have a documented scope for your QMS. This scope should define which parts of your organization, processes, products, and services are covered under your QMS. A compliant system would include a statement that identifies these boundaries clearly. Look for any records or documents that specify what is included in your QMS and, if certain processes or functions are excluded, ensure that you have justified why these exclusions don’t affect your ability to deliver quality products and services.

2. Considering External and Internal Issues (Section 4.1) and Interested Party Requirements (Section 4.2):

When setting the scope, you need to account for both the external and internal factors identified in section 4.1 and the needs of relevant interested parties from section 4.2. Confirm that your scope statement reflects these considerations, demonstrating that you’ve taken into account issues like market trends, regulatory requirements, stakeholder expectations, and internal resources. This information should be documented and should show a logical connection between the scope and these influencing factors. If you don’t see these considerations reflected in your scope, you may have a gap in addressing all requirements.

3. Documenting Products and Services Covered:

Your QMS scope should specify the types of products and services it covers. Check if this information is clearly stated in your documented scope, as this helps establish the context and focus areas of your QMS. If certain products or services are excluded, the scope should provide a clear justification. For example, if you’re only certifying a specific division within the company, your scope should specify this limitation and justify any exclusions so it doesn’t mislead customers or other stakeholders.

4. Ensuring Availability and Maintenance of Scope Documentation:

Lastly, ISO 9001 requires that your scope is documented, readily available, and maintained as part of your QMS documentation. Confirm that you have a controlled document that outlines your scope and that it is easily accessible to relevant personnel. This documentation should also be reviewed periodically to ensure it remains accurate and relevant as the organization and its context evolve. If you cannot locate this document, or if it is outdated, this could indicate a gap in meeting section 4.3.

By reviewing each of these areas, you can determine if your current QMS scope meets ISO 9001 requirements or if there are areas that may require updates to achieve full compliance.