Clause 5.3 - Leadership by Defined Roles & Responsibilities
Standard Operating Procedure (SOP)
Clause 5.3 – Organizational Roles, Responsibilities and Authorities
ISO 9001:2015
Document No.: QMS/SOP/006
Version: 01
Effective Date: __________
Review Date: __________
Approved By: Head – Quality / Site Head
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1. Purpose
To define, assign, communicate, and maintain organizational roles, responsibilities, and authorities to ensure the effective implementation and continual improvement of the Quality Management System (QMS) in accordance with ISO 9001:2015 Clause 5.3.
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2. Scope
This procedure applies to all employees, departments, and functions involved in the manufacture, testing, storage, release, and distribution of Active Pharmaceutical Ingredients (APIs).
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3. Definitions
Responsibility: The duty assigned to perform a specific activity.
Authority: The power to make decisions and take actions within an assigned role.
Accountability: The obligation to ensure assigned responsibilities are effectively completed.
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4. Procedure
4.1 Organizational Structure
Top Management shall establish and maintain an organization structure that clearly defines reporting relationships, responsibilities, and authorities.
The organization chart shall:
- Identify all key positions.
- Define reporting relationships.
- Be reviewed whenever significant organizational changes occur.
- Be maintained as controlled documented information.
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4.2 Roles and Responsibilities
Top Management
- Establish the Quality Management System.
- Provide leadership and strategic direction.
- Ensure Quality Policy and Quality Objectives are established.
- Provide adequate resources.
- Conduct Management Reviews.
- Promote customer focus and continual improvement.
Head – Quality Assurance
- Maintain the QMS.
- Ensure compliance with ISO 9001 and applicable GMP requirements.
- Approve quality system documents.
- Oversee internal audits, CAPA, deviations, change controls, and risk management.
- Report QMS performance to Top Management.
Production Head
- Ensure manufacturing activities comply with approved procedures.
- Achieve production targets without compromising quality.
- Investigate manufacturing deviations.
- Ensure trained personnel and qualified equipment are available.
Quality Control Head
- Ensure testing complies with approved specifications and methods.
- Review analytical data.
- Ensure laboratory compliance and data integrity.
- Approve laboratory results as authorized.
Engineering Head
- Maintain facilities, utilities, and equipment.
- Ensure calibration, preventive maintenance, and equipment qualification.
- Support validation activities.
Warehouse Head
- Control receipt, storage, dispensing, and dispatch of materials.
- Ensure inventory accuracy and traceability.
- Maintain storage conditions.
Human Resources
- Ensure recruitment of competent personnel.
- Coordinate induction and periodic training.
- Maintain employee competency records.
All Employees
- Follow approved procedures.
- Complete documentation accurately.
- Report deviations and quality concerns promptly.
- Participate in continual improvement initiatives.
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4.3 Communication of Responsibilities
Responsibilities and authorities shall be communicated through:
- Organization charts.
- Job descriptions.
- SOPs.
- Training programmes.
- Department meetings.
- Management communications.
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4.4 Review of Roles
Roles and responsibilities shall be reviewed:
- During organizational restructuring.
- Following significant business changes.
- During Management Review.
- When regulatory or customer requirements change.
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5. Documented Information
The following documents and records shall be maintained:
Documents
- Organization Chart
- Job Descriptions
- Delegation of Authority Matrix
- Training Matrix
Records
- Employee Training Records
- Competency Assessments
- Management Review Minutes
- Internal Audit Reports
- Appointment Letters (where applicable)
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6. Responsibilities for Maintaining this Procedure
Top Management
- Approve the organizational structure.
- Ensure adequate resources are available.
Head – Quality Assurance
- Maintain this procedure.
- Verify implementation through internal audits.
Department Heads
- Ensure employees understand their roles and responsibilities.
- Keep job descriptions current.
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7. References
- ISO 9001:2015 – Clause 5.3
- Quality Manual
- Human Resources Procedure
- Training Procedure
- Management Review Procedure
- Document Control Procedure
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Auditor Expectations
During an ISO 9001 audit, auditors typically verify that:
- Roles, responsibilities, and authorities are clearly defined.
- Employees understand their responsibilities.
- Job descriptions are current and available.
- Responsibilities are communicated effectively.
- Top Management demonstrates leadership and accountability.
- QMS responsibilities are assigned and implemented.
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Typical Auditor Questions
1. What are your job responsibilities?
2. Who do you report to?
3. Who has authority to approve deviations, CAPA, and change controls?
4. How were your responsibilities communicated?
5. How do you know you are competent to perform your work?
6. How does Top Management support the QMS?
7. Where is the organization chart maintained?
8. What happens when responsibilities change?
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Expected Employee Response
"I know my responsibilities from my job description, SOPs, and training. I follow approved procedures, complete records accurately, report any deviations immediately, and escalate issues to my supervisor when required. My responsibilities and authority are clearly communicated, and I receive training whenever there are changes."
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