Page 17 - 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

Quality

Manual

Standard Operating Procedures

Other Documents

Retained documented information

Levels of Documentation of PPTL QMS

LEVEL 1: QUALITY MANUAL

This is a top-level policy document that consists of corporate goals and policies that ensure the smooth

operation of PPTL. It includes the following:

• The company profile.

• External and internal issues that can affect PPTL QMS.

• Needs and expectations of interested parties.

• The scope of the PPTL QMS.

• Interaction of processes.

• References to the procedures and other documents of the QMS.

• Justification for any clause of the ISO 9001 standard that is not applicable.

• Determination and review of requirements to products and services.

LEVEL 2: STANDARD OPERATING PROCEDURES

These documents describe the actual processes, and controls applied, to the activities concerned with the

attainment of quality products/services. Processes have one or more procedures related to them. Procedures

explain what, who and how activities are carried out in the company. They are comprised of the 9 mandatory

procedures, specified in the quality manual and other procedures, all referred to as QA SOPs. These include:

• Documents Control - PPTL/SOP/QA/003.
• Records Control – PPTL/SOP/QA/004.

• Quality Audits – PPTL/SOP/QA/005.
• Handling Deviations - PPTL/SOP/QA/006.

• Change Control – PPTL/SOP/QA/007.

• Trainings – PPTL/SOP/QA/008.

• Management Review – PPTL/SOP/QA/009.

• Risk Management – PPTL/SOP/QA/010.

• Sub-Contractor Management – PPTL/SOP/QA/011.

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