To assess if your quality management system (QMS) complies with ISO 9001 section 5.3, you need to ensure that roles, responsibilities, and authorities within your organization are clearly assigned, communicated, and understood, specifically with regard to maintaining QMS conformity. Here’s what to examine in your current system to determine if you’re meeting this requirement.

1. Clarity of Roles and Responsibilities:

Start by reviewing whether all relevant roles in your organization have clear, documented responsibilities related to the QMS. This includes identifying the individual(s) responsible for ensuring that the QMS meets ISO 9001 requirements. Look for role descriptions, job profiles, or a responsibilities matrix that specifically outline these duties. If responsibilities related to QMS compliance are not clearly defined or are ambiguous, this could indicate a gap in meeting section 5.3.

2. Communication of Responsibilities and Authorities:

Examine how these QMS roles and responsibilities are communicated across the organization. This could include onboarding materials, training sessions, or ongoing internal communications. Verify that everyone understands who is responsible for maintaining the QMS, meeting standards, and driving continual improvement. Evidence of communication could include meeting minutes, internal announcements, or accessible documentation on shared platforms. If these responsibilities are not actively communicated, it may suggest that the organization lacks clarity on QMS-related roles and duties.

3. Management’s Role in QMS Conformity (5.3a):

ISO 9001 requires that top management specifically assigns responsibility and authority to ensure that the QMS conforms to the standard’s requirements. Check if there is a designated QMS representative (such as a Quality Manager) who has been explicitly given the authority to oversee compliance. This person should have the authority to make QMS-related decisions, initiate improvements, and address non-conformities. If no one has been formally assigned this responsibility or if their authority is limited, this could indicate a gap in alignment with section 5.3(a).

4. Consistency and Understanding Across the Organization:

Finally, assess whether staff at all levels understand their QMS responsibilities. You might do this through employee feedback, observations, or internal audits. Employees should not only be aware of their own roles but also understand how their responsibilities support the QMS as a whole. If there’s inconsistency or confusion among employees about their role in the QMS, this may suggest that further clarification is needed to meet this requirement.

By examining each of these areas, you can determine if your organization’s structure of roles, responsibilities, and authorities meets the requirements of ISO 9001 section 5.3 or if additional clarification, documentation, or communication is needed to ensure compliance.