Page 4 - 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
1.0 TERMS AND DEFINITIONS
For the purposes of this quality manual, the terms and definitions found in the current edition of ISO 9000
International Standard shall apply.
Customer Firm or person having a contractual agreement with, or the recipient of a
product from Phillips Pharmaceuticals (Tanzania) Limited.
Internal Audit Systematic independent and documented process for obtaining audit evidence and
evaluating it objectively to examine the extent to which audit criteria are fulfilled.
Organization Phillips Pharmaceuticals (Tanzania) Limited.
Procedure Specified way to carry out an activity or a process.
Product Result of a process which is the result of a number of four generic product
categories including hardware, software, processed materials and services.
Supplier Party to whom an order has been placed by the organization for the purchase of
supplies, or the execution of a specific part of a particular order.
Quality Management System Management System to direct and control an organization with regard to its
quality.
In addition, the following terms/Acronym are also referenced:
ERP Enterprise Resource Planning
EU European Union
GDP Good Distribution Practice
GFD Group Financial Director
GMD Director
HR Human Resource
PPTL Phillips Pharmaceuticals (Tanzania) Limited
QA Quality Assurance
QM Quality Manual
QMR Quality Management Representative
QMS Quality Management System
SOP Standard Operating Procedure
TFDA Tanzania Food and Drug Authority
USAID United States Agency for International Development
WHO World Health Organization
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