Quality Management Systems

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Objectives

The objective on QMS is to ensure implementation of QMS in line with national and international standards for NMRAs handling the regulation of medicines in the West African region. This is to ensure;

• A common QMS based on national, regional, continental and internationally recognized standards developed and adopted by NMRAs’ in the West African Member States.
• QMS policies and manuals in each of the West African member states NMRAs implemented to ensure efficiency and transparency in the provision of regulatory services by the NMRAs in the region

Documented Information for Quality Management System

Guidelines/Guidance Documents; these include;

ISO 9001:2015 Requirements

ISO 9001 states the requirements for your Quality Management System (QMS):
• Scope
• Normative References
• Terms and Definitions
• Context of the Organization
• Leadership
• Planning
• Support
• Operation
• Performance Evaluation
• Improvement

WA-MRH Programme Quality Policy

SOPs (Standard Operating Procedure)

SOP for Control of Documented Information

Purpose:

• To provide a procedure for the control of documented information in the West Africa Health Organization (WAHO) medicines regulation harmonization (MRH) programme.
• Documented information controls (Documents & Records) cover:
• Preparation and approval of documented information for adequacy prior to issue
• Review and update of documented information
• Identification of change and current revision status of documents
• Access to relevant versions of applicable documented information by authorised persons
• Ensuring that documented information remain legible and identifiable
• Identification and proper maintenance of documented information of external origin
• Prevention of unintended use of obsolete documented information

Scope

• This procedure applies to documents related to the quality management system in the WA-MRH programme.

SOP for Handling Nonconformance & Corrective Actions

Purpose

• This SOP describes the steps involved in:
• Identification, processing and dispositioning of Non-conforming services
• Addressing Corrective Actions

Scope

• This document covers all activities relating to handling of non-conformances and corrective actions by EWGs under the West Africa Medicines Harmonization (WA-MRH) programme

SOP for Internal Quality Audit

Purpose

• This SOP describes the steps involved in:To define activities involved in planning, conducting and reporting Internal Quality Audits and follow-up actions.

Scope

• This SOP applies to all processes relating to internal audits for the WA-MRH programme

SOP for Management Review

Purpose

• This procedure defines the activities involved in the management review of the Quality System of the West Africa Medicines Regulatory Harmonization (WA-MRH) programme in order to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of WA-MRH programme.

Scope

• This SOP applies to the Quality Management System of WA-MRH Programme.

SOP for Monitoring and Evaluation

Purpose

• To describe the methods in conducting measurement, analysis and continuous improvement regulatory processes according to ISO 9001:2015 requirements and other policies to be used within the WA-MRH programme.

Scope

• This procedure covers all the integrated management system within the WA-MRH programme.

SOP for Client service:

Purpose:

• To outline procedure to receive client complaint and feedback for prompt action

Scope:

• Any complaint and feedback relating to the services being rendered by the WA-MRH programme.