Page 16 - 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

process areas.

• Minutes of departmental, business operations and management meetings.

• Results of both internal and external audits.

7.2 COMPETENCE

• PPTL has determined the necessary competence of persons doing the work under its control that affects the
performance and effectiveness of the QMS.

• PPTL has ensured that the persons are competent on the basis of appropriate education, training or

experience. Employees are given job descriptions and made aware of the relevance and importance of

their activities and how they contribute to the achievement of quality objectives are defined. The HR

maintains records of education, experience and training as stated in the SOP Number

PPTL/SOP/HR/003.

• Will retain applicable documented information as evidence of competence.

7.3 AWARENESS

The organization shall ensure that the persons doing the work under the organization control are aware of:

• Quality Policy through creating awareness for the new staff as stated in the SOP Number PPTL/SOP/HR/001 as

well as placing it in strategic places for the staff to see.

• Relevant Quality Objectives. The process leads shall set quality objectives for their area and monitor them

quarterly as well as create awareness of the quality objectives to their staff.

• The process leads will ensure that the persons understand their contribution to the effectiveness of the QMS

including the benefits of improved performance.

• The persons will also be made aware of the implications of not conforming to the QMS requirements.

7.4 COMMUNICATION

PPTL has determined the internal and external communications relevant to the QMS including:

• What to communicate - PPTL will communicate the Quality Policy and Quality Objectives.

• When to communicate - Quality Policy will be communicated to new staff and all the other staff continually,

and to interested parties when required.

• With whom to communicate - Staff and Interested parties.

• How to communicate - Quality Policy will be communicated to new staff through the introduction to the PPTL
QMS as well as mounting it in strategic places.

• Who communicates - The Top Management will communicate Quality Policy while process leads will
communicate quality objectives to the staff.

7.5 DOCUMENTED INFORMATION

7.5.1 GENERAL

PPTL Quality Management System shall include:

• Documented Information required by this standard example: Quality Policy, Quality Objectives, SOPs and

Organizational Structure.

• Documented Information determined by PPTL as being necessary for the effectiveness of the QMS example:

Quality Manual and Mandatory Procedures named Quality Assurance Procedures.

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