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Quality

Commitment to quality at our core

Product Quality Assurance

PFSCM assures product quality by procuring from suppliers that have been approved by a Stringent Regulatory Authority (SRA) or prequalified by the World Health Organization (WHO).

For products not approved by an SRA or prequalified by WHO, PFSCM conducts dossier reviews and performs quality audits of manufacturers for compliance with WHO Good Manufacturing Practice (cGMP) guidelines before these products can be procured.

In addition, PFSCM has an established automated online sampling and quality testing system through which products are flagged for quality testing to continuously monitor quality standards.

PFSCM also prequalifies our suppliers to maintain and grow a supplier network for our clients. Our audits cover aspects of the WHO’s cGMP and “A Model Quality Assurance System for Procurement Agencies” (MQAS).

In 2017, PFSCM audited more than 58 suppliers in eight African countries. In total, 37 (63%) of the 58 vendors passed the pre-qualification audits.

PFSCM participated in the working group that collaborated with the committee to review and develop the WHO MQAS.

We gained vast experience in prequalifying vendors during the 10 years we managed the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) Supply Chain Management System (SCMS) project. During this period, PFSCM prequalified 57 manufacturers, 10 of which were based on the African continent.

 

Quality Management System

Quality is at the core of PFSCM and all our services comply with our ISO 9001:2015 certified Quality Management System.

PFSCM has a reputation for uncompromising quality standards, from the products we source and procure, to the systems and processes we deploy to meet our clients’ requirements.

PFSCM received ISO 9001:2015 certification in November 2017, and we were awarded the previous ISO 9001:2008 certification standard  in 2014. The certifications were both awarded by one of the world’s most reputable certification bodies for management systems, DQS Management Systems Solutions.

What does ISO 9001:2015 mean for PFSCM clients?

ISO 9001:2015 Quality Management System certification provides PFSCM’s current and new clients with the assurance that PFSCM’s business is conducted within a standardized framework, with documented process methodology, competent staff, and defined roles, as well as an understanding of client requirements.

PFSCM upholds the  key global principles of quality management systems:

 

  • Improving customer satisfaction: A fundamental principle of ISO 9001:2015 is to continuously improve customer satisfaction through planning and striving to meet and exceed customer expectations.
  • Improving process integration: ISO 9001:2015’s process approach enables an organization to easily identify areas where efficiency and cost savings can be improved. Improved process flow and integration reduces errors and inefficiencies, increasing service levels and cost savings for customers.
  • Upholding evidence-based decisions: Through ISO 9001:2015, the organization commits to making decisions based on accurately analyzed data and facts. This not only ensures that the organization is able to meet and measure its goals and progress, but also gives customers the assurance that decisions are based on sound judgement.
  • Continuous improvement: A requirement of ISO 9001:2015 is to continuously improve the suitability, adequacy, and effectiveness of the organization’s quality management system. These improvements are based on the analysis of results and the outcomes of management reviews

The ISO 9001:2015 certification provides clients with peace of mind in knowing that their expectations will be met in a transparent and compliant manner.

View our certificates below:

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