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Quality

Our Quality Promise

Quality Management System

Our ISO 9001:2015 certified Quality Management System (QMS) informs all our decisions and ensures continuous improvement, customer satisfaction, and product and service excellence.

PFSCM was recertified to ISO 9001:2015 in August 2020. Our QMS received its initial ISO 9001:2008 certification in 2014, and the organization advanced to the latest ISO 9001:2015 standard in 2017.

PFSCM has upheld the highest quality standards, ensuring successful annual surveillance audits and registration by one of the world’s most reputable certification bodies for management systems, DQS Management Systems Solutions.

Through our QMS and standardized ISO framework we ensure that:

 

  • All processes and procedures are documented
  • Staff roles are clearly defined and reviewed regularly
  • Internal quality audits and self-inspections are completed periodically
  • Client requirements and expectations are understood, met and exceeded
  • A robust incident management system is used to report and track incidents
  • Deficiencies are identified, corrected and improved upon

Product Quality Assurance

PFSCM’s clients are assured that products are safe, fit-for-use, and produced by reliable well-known and reliable manufacturers.

PFSCM upholds a strict quality assurance (QA) policy and program 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.

PFSCM’s Quality Management Unit also manages an innovative product quality assurance program.

Through this program manufacturers, suppliers and distributors are pre-qualified and audited to improve their compliance with the World Health Organization (WHO) Model for Quality Assurance System for Procurement Agencies Guideline (MQAS), current Good Manufacturing Practices (cGMP) and current Good Distribution Practices (cGDP), where applicable. 

Through this effort PFSCM is expanding the pool of local reliable sources bringing life-saving commodities closer to communities in need and building self-reliant supply chains.

Our Code of Conduct

PFSCM’s Code of Business Conduct and Ethics

PFSCM’s code of business conduct and ethics outlines the values, principles, and acceptable practices underlying PFSCM’s operations. The code serves as a guide for all staff, agents, contractors, and suppliers located domestically and abroad. Terms include, but are not limited to:

  • Compliance with all applicable laws, regulations, rules, and regulatory orders. This includes the Foreign Corrupt Practices Act (FCPA), applicable patent and antitrust law, applicable Federal Acquisition Regulations, the Executive Order on Terrorism Financing, and the U.S. Export Control Act, in addition to any laws that are applicable in the countries where we do business.
  • Avoidance of conflicts of interest.
  • Rules around compliant accounting and public disclosure.
  • Standards for personal behavior.

 

PFSCM’s Whistleblower Policy and Procedure

PFSCM’s established, formal whistleblower procedure outlines policies for the submission and  management of complaints received by PFSCM regarding accounting, internal control, or auditing matters. The policy ensures protections for whistleblowers reporting compliance and/or business ethics concerns.

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