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Quality

Commitment to quality at our core

Product Quality Assurance

PFSCM upholds a strict product quality assurance (QA) policy that ensures patient safety, and prevents costly and wasteful product quality issues that may result in destruction or recalls.

PFSCM only procures products that comply with defined quality requirements as prescribed in applicable QA policies. This includes products that are either prequalified by the World Health Organization (WHO), approved by stringent regulatory authorities (SRAs), or the International Medical Device Regulatory Forum (IMDRF); and meet national regulatory requirements.

 

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. Local sourcing stimulates economies and uplift companies, providing them access to international buyers. Our audits cover aspects of the WHO’s cGMP and “A Model Quality Assurance System for Procurement Agencies” (MQAS).

In the past ten years, PFSCM has conducted over 100 audits. The most recent audits were done in South Africa and Uganda in 2020.

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

 

 

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 was successfully recertified in 2020. We received our first ISO 9001:2008 certification standard in 2014. The certifications were 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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