Clause 5 of ISO 9001:2015 places direct accountability on top management for the effectiveness of the quality management system. The 2015 revision eliminated the concept of a “management representative” and instead requires top management to take active ownership of the QMS, demonstrate customer focus, and drive a quality culture throughout the organization.
Clause 5.1.1: Leadership and Commitment — General
Top management must demonstrate leadership and commitment by taking accountability for QMS effectiveness, ensuring the quality policy and objectives are established and compatible with strategic direction, ensuring integration of QMS requirements into the organization’s business processes, promoting the use of the process approach and risk-based thinking, ensuring resources are available, communicating the importance of effective quality management, ensuring the QMS achieves its intended results, and directing and supporting persons to contribute to QMS effectiveness.
Clause 5.1.2: Customer Focus
Top management must demonstrate leadership and commitment with respect to customer focus by ensuring that customer and applicable statutory/regulatory requirements are determined, understood, and consistently met, risks and opportunities that can affect product/service conformity and customer satisfaction are addressed, and the focus on enhancing customer satisfaction is maintained.
Clause 5.2: Quality Policy
The quality policy must be appropriate to the purpose and context of the organization, provide a framework for setting quality objectives, include a commitment to satisfy applicable requirements, and include a commitment to continual improvement. It must be available as documented information, communicated and understood within the organization, and available to relevant interested parties.
Best Practices
- Keep the quality policy concise and specific to your organization
- Ensure it is meaningful — avoid generic boilerplate language
- Communicate the policy in ways all employees understand
- Post the policy prominently and include it in onboarding
- Review the policy at least annually during management review
Common Pitfalls
- Top management treating the QMS as something the quality department owns
- Creating a quality policy disconnected from actual business operations
- Failing to communicate the policy beyond the quality team
- Not reviewing the policy when strategy or context changes
Related Ecesis Solutions
Document Management
Version-controlled procedures and records
Audits & Inspections
Schedule, conduct, and track audit findings
Nonconformity Tracking
Report, investigate, and resolve nonconformities
Training Management
Track competence requirements and records
Change Management
Structured review of planned changes
Compliance Obligations
Track requirements and evaluation schedules
