Page 26 - 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

• Performance and effectiveness of the QMS.

• If planning has been implemented effectively.

• Effectiveness of actions taken to address risks and opportunities.

• Performance of external providers.

• Need for improvements to the QMS.

9.2 INTERNAL AUDIT

9.2.1 PPTL shall conduct internal audits at planned intervals to provide information on whether the QMS is
effectively implemented and maintained and conforms to:

• The organization’s own requirements for its QMS.

• The requirements of this International Standard.

9.2.2 PPTL has done the following:

• Planned, established, implemented and maintained an audit programme(s) including the frequency, methods,
responsibilities, planning requirements and reporting, which takes into consideration the importance of the

processes concerned, changes affecting the organization, and the results of previous audits.

• Defined the audit criteria and scope for each audit.

• Selected auditors and conduct audits to ensure objectivity and the impartiality of the audit process; audits are
conducted by personnel other than those who perform the activity being audited.

• Ensured that the results of the audits are reported to relevant management.

• Taken appropriate correction and corrective actions without undue delay.

• Retained documented information as evidence of the implementation of the audit programme and the audit

results.

The documented procedure for Internal Quality Audits, PPTL/SOP/QA/005 includes the responsibilities and

requirements for conducting audits, ensuring their independence, recording results and reporting to

management.

Management ensures that timely corrective action is taken on deficiencies found during the audit. Follow up
action includes the verification of the implementation of corrective action, and the reporting of verification

results.

9.3 MANAGEMENT REVIEW

9.3.1 GENERAL

PPTL top management shall review the organization’s QMS, at planned intervals, to ensure its continuing suitability,

adequacy, effectiveness and alignment with the strategic direction of the organization. The Director in conjunction

with top management, QMR and appropriate staff, review the PPTL QMS at planned intervals of at least twice a

year to ensure its continuing suitability, adequacy and effectiveness and alignment with the strategic direction

of the organization. The review is for improvement and the need for changes to the system and to verify that

the quality policy and objectives are being satisfied. The meeting is arranged by the QMR and chaired by the

Director. Other personnel may attend where necessary to provide relevant input.

9.3.2 MANAGEMENT REVIEW INPUTS

The management review shall be planned and carried out taking into consideration the following:

• Status of actions from previous management reviews.

• Changes in external and internal issues that could affect the QMS.

• Information on the performance of the PPTL QMS, including:

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