Page 9 - PPTL.QM.001 Iss 01 - ISO 9001 Quality Manual - Full [Unsigned]

QUALITY MANUAL

PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED

DOCUMENT NUMBER ISSUE NUMBER SUPERSEDES EFFECTIVE DATE

PPTL/QM/001 02 01 14.12.2018

5.0 LEADERSHIP

5.1. GENERAL

The Directors and other Top Management demonstrate leadership and commitment with respect to the Quality

Management System by:

• Taking Accountability for the Effectiveness of the Quality Management System.

• Ensuring the Quality Policy and the Quality Objectives are established for the QMS and are compatible

with the context and strategic direction of PPTL.

• Ensuring the integration of QMS requirements into PPTL Business Processes.

• Promoting the use of the Process Approach and Risk Based Thinking.

• Ensuring the resources needed for the QMS are available.

• Communicating the importance of Effective Quality Management and of conforming to the QMS

requirements.

• Ensuring the QMS achieves its intended results.

• Engaging, directing and supporting persons to contribute to the effectiveness of the QMS.

• Promoting improvement.

• Supporting other relevant management roles to demonstrate leadership as it applies to their areas of

responsibility.

To demonstrate evidence of leadership and commitment to the development and improvement of the Quality

Management System, the Director has established a Quality Policy and ensured that Quality Objectives are
established at relevant processes and ensures the availability of necessary resources. The Management Review

Meetings are chaired by the Director.

The Director has assigned the Manager – Quality Assurance and QPPV as the QMR with the delegated authority

and responsibility for the development, overall implementation and maintenance of the Quality Management

System together with the control and issue of all Quality Documentation.

The QMR is responsible for monitoring the QMS and in particular for advising, training other personnel in the

system, continually looking for improvements, ensuring that internal quality audits are carried out as detailed

on a planned schedule, ensuring that all corrective and preventive actions arising from audits are closed out,

reporting to the management review on the performance, including need for improvement and the awareness

of customer needs and requirements throughout Phillips Pharmaceuticals (Tanzania) Limited.

5.1.1 CUSTOMER FOCUS
The Directors and other Top Management demonstrate leadership and commitment to Customer Focus by

ensuring that:

• Customer and applicable statutory and regulatory requirements are determined, understood and

consistently met.

• The risks and opportunities that can affect conformity of products and services and the ability to

enhance Customer Satisfaction are determined and addressed

• The focus on enhancing Customer Satisfaction is maintained.

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