Page 10 - 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

To demonstrate these PPTL has set up a Customer Support Department with several employees and a Director

to oversee. Customer satisfaction surveys are done annually and customer concerns and complaints are

tracked, root cause analysis done and then they are closed. PPTL has also established a risk management

procedure PPTL/SOP/QA/010 to ensure that risks that can affect the conformity of products and services are
determined and addressed.

5.2 POLICY

5.2.1 ESTABLISHING THE QUALITY POLICY

PPTL top management has established a Quality Policy that:

• Is appropriate to the purpose of PPTL, its Context and supports its Strategic Direction.

• Provides a framework for setting Quality Objectives.

• Includes a Commitment to satisfy applicable requirements.

• Includes a Commitment to Continual Improvement of the QMS.

The Policy (see Appendix VI – PPTL/QMS/QA/023) is approved by the Director and is supported at all levels of

management within the Phillips Pharmaceuticals (Tanzania) Limited and will be reviewed regularly for continual

improvement.

5.2.2 COMMUNICATING THE QUALITY POLICY
PPTL Quality Policy:

• Shall be available and maintained as a Documented Information.

• Be communicated, understood and applied within the Organization.
• Be available to relevant interested parties as appropriate.

A Quality Policy which is appropriate to the purpose of Phillips Pharmaceuticals (Tanzania) Limited has been

established and communicated by ensuring that it is placed at key areas including at the Reception as well

being communicated to new staff during their Induction Session of PPTL QMS. It shall also be included within

the corporate profile which is circulated amongst our interested parties before engagement. The Quality Policy

has also been translated into a Kiswahili version for better understanding of the staff (See – Appendix VII).

5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES

The Director has ensured that the responsibilities and authorities for relevant roles are assigned, communicated, and

understood within the organization. They have assigned responsibility and authority for the following:

• Ensuring that the QMS conforms to the requirements of the current international ISO 9001 standard.

• Ensuring that the processes are delivering their intended inputs.

• Reporting on the performance of the QMS and on opportunities for improvement to the top management.

• Ensuring the promotion of customer focus throughout the organization.

• Ensuring that the integrity of the QMS is maintained when changes to the QMS are planned and implemented.

5.3.1 ORGANIZATION STRUCTURE
PPTL is staffed by a blend of experienced personnel including registered pharmacists who are skilled in their

areas of operation. The hierarchical structure of PPTL Company is as shown in Appendix VIII –

PPTL/QMS/QA/024.

PPTL ensures that the responsibilities, authority and the interrelation of all personnel who manage, perform

and verify work affecting quality are defined and communicated in order to facilitate effective quality

management. All key personnel have been given authorities and responsibilities to enable them to assist in the

P a g e 9 | 28