Clause 5 – Leadership of ISO 9001:2015 ensures that top management actively leads, supports, and is accountable for the Quality Management System (QMS). Leadership cannot be delegated solely to the Quality Assurance department.
The clause has three sub-clauses:
5.1 Leadership and Commitment
5.2 Quality Policy
5.3 Organizational Roles, Responsibilities, and Authorities
Below is a sample procedure suitable for an API pharmaceutical manufacturing company.
Clause 5 – Leadership
ISO 9001:2015
1. Purpose
To define how Top Management demonstrates leadership, establishes the Quality Policy, assigns responsibilities, and promotes continual improvement of the Quality Management System (QMS).
2. Scope
This procedure applies to Top Management and all departments involved in the QMS.
3. Leadership and Commitment (Clause 5.1)
Top Management shall:
- Be accountable for the effectiveness of the QMS.
- Establish and maintain the Quality Policy and Quality Objectives.
- Ensure the QMS is integrated into business processes.
- Promote process-based thinking and risk-based thinking.
- Provide adequate resources, including personnel, infrastructure, and training.
- Ensure compliance with customer, statutory, and regulatory requirements.
- Promote continual improvement.
- Support managers in achieving quality objectives.
- Participate in Management Review meetings.
- Promote a culture of quality, compliance, and customer focus.
4. Customer Focus (Clause 5.1.2)
Top Management shall ensure that:
- Customer requirements are identified and fulfilled.
- Applicable statutory and regulatory requirements are met.
- Customer satisfaction is monitored and improved.
- Risks and opportunities affecting product quality are addressed.
5. Quality Policy (Clause 5.2)
The organization shall establish a Quality Policy that:
- Is appropriate to the organization's purpose and strategic direction.
- Provides a framework for setting quality objectives.
- Includes a commitment to satisfy customer and regulatory requirements.
- Includes a commitment to continual improvement.
- Is communicated, understood, and applied throughout the organization.
- Is available to relevant interested parties.
Sample Quality Policy
"Our organization is committed to manufacturing safe, effective, and high-quality Active Pharmaceutical Ingredients that consistently meet customer expectations and applicable regulatory requirements. We are committed to continual improvement of our Quality Management System through employee involvement, innovation, compliance, and operational excellence."
6. Organizational Roles, Responsibilities, and Authorities (Clause 5.3)
Top Management shall define and communicate responsibilities.
Managing Director / Site Head
- Provide strategic direction.
- Allocate resources.
- Review QMS performance.
Head – Quality Assurance
- Maintain the QMS.
- Ensure compliance with ISO 9001 and GMP.
- Coordinate internal audits and Management Reviews.
Production Head
- Ensure manufacturing complies with approved procedures.
- Achieve production and quality targets.
Quality Control Head
- Ensure accurate testing and timely release of results.
- Maintain laboratory compliance.
Engineering Head
- Maintain equipment, utilities, and facilities.
- Ensure calibration and preventive maintenance.
All Employees
- Follow approved procedures.
- Report deviations and quality concerns.
- Participate in training and continual improvement.
7. Leadership Activities
Top Management demonstrates leadership through:
- Regular Gemba Walks.
- Management Review Meetings.
- Internal Audit Reviews.
- KPI Reviews.
- Customer Complaint Reviews.
- Risk Review Meetings.
- Resource Planning.
- Employee Recognition and Engagement.
8. Records
The following records shall be maintained:
- Quality Policy
- Organization Chart
- Job Descriptions
- Management Review Minutes
- Quality Objectives
- KPI Reports
- Training Records
- Resource Planning Records
9. References
- ISO 9001:2015 – Clause 5
- Quality Manual
- Management Review Procedure
- Human Resources Procedure
Post a Comment