Page 7 - PPTL.QM.001 Iss 01 - ISO 9001 Quality Manual - Full [Unsigned]
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QUALITY MANUAL
PHILLIPS PHARMACEUTICALS (TANZANIA) LIMITED
DOCUMENT NUMBER ISSUE NUMBER SUPERSEDES EFFECTIVE DATE
PPTL/QM/001 02 01 14.12.2018
4.0 CONTEXT OF THE ORGANISATION
4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT
PPTL has determined the External (see Appendix II – PPTL/QMS/QA/019) and the Internal Issues (see Appendix
III – PPTL/QMS/QA/020) that are relevant to its purpose and its strategic direction and that can affect its ability
to achieve desired results of its Quality Management System. Such internal and external issues are subject to
change and thus require monitoring and review. The review is done annually during Management Review as
stated in the SOP Number PPTL/SOP/QA/009; Point 5.3.8. Monitoring is a constant process with information
about external and internal issues available from many sources, such as through internal documented
information and meetings, in the national and international press, websites, publications from national
statistics offices and other government departments, professional and technical publications, conferences and
meetings with relevant agencies, meetings with customers and relevant interested parties, and professional
associations.
4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES
Due to their effect or potential effect on the organization ability to consistently provide products and services that
meet customer and applicable statutory and regulatory requirements, PPTL has determined the interested parties that
are relevant to the QMS and their requirements (see Appendix IV – PPTL/QMS/QA/021).
4.3 DETERMINE THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM
The scope of the PPTL QMS will cover the Entire Organization located at Plot 111, Vingunguti Industrial Area, Dar-es-
Salaam, Tanzania.
PPTL shall apply the requirements of these International Standard but Clause 8.3 on Design and Development of
Products and Services will not be applicable within the above determined scope of its Quality Management
System. This is because PPTL does not do any design or development. The fact that this particular clause is not
applicable does not affect the PPTL’s ability, or responsibility to ensure conformity of its products and services
and enhancement of customer satisfaction. We confirm the quality of the products we receive through our
internal quality control activities as stated in the SOP Number – PPTL/SOP/DH/002 – Receipt of Goods.
4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES
PPTL has established, documented, implemented a QMS which we maintain and continually strive to improve
its effectiveness in accordance with the requirements of the current ISO 9001.
4.4.1 PPTL’S PROCESSES
The company has determined the main business or core processes as well as relevant support processes and
their application throughout the organization. Within each process are other sub processes:
• Determined the sequence and interaction of the processes. (See Appendix V – PPTL/QMS/QA/022)
• PPTL has determined and applied criteria and methods (including monitoring, measurements, and
related performance indicators) needed to ensure effective operation and control of these processes.
• Determined the resources for these processes and ensured their availability.
• PPTL has also assigned the responsibilities and authorities for these processes.
• Addressed the risks and opportunities determined.
• Continually evaluate the processes and implement any changes needed to ensure that these processes
achieve intended results.
• Improve the processes and the Quality Management System. The PPTL’s QMS is comprised of the processes
as listed in the table that follows:
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