Quality: quality assurance and management

Commitment to quality at our core

We are known for our uncompromising quality standards, from the products we source and procure, to the systems and processes we deploy to meet our clients’ requirements.

We take the utmost care to ensure the organizations we procure from, share our passion for-, and commitment to quality. We have due diligence procedures in place to ensure our suppliers’ compliance with quality management system requirements such as those specified by ISO 9001 and ISO 13485.

Product Quality Assurance

We uphold 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.

We only procure products that are:

  • 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.

Non-Pharma Products Prequalification Guide for Suppliers

PFSCM prequalification of non-pharmaceutical products is coordinated through our Quality Assurance & Regulatory (QA&R) unit. This quality and regulatory assessment of non-pharmaceutical products – through a standardized procedure in compliance with the WHO model quality assurance system (MQAS) for procurement agencies – is aimed at determining whether a product meets our prequalification requirements and can be procured.

  • The full prequalification assessment process includes the review of a full product dossier according to the quality and regulatory requirements defined for each product risk class.
  • The duration of the validity of the prequalification status of a product is dependent on the manufacturer’s continuous fulfillment of our quality and regulatory requirements.
  • The findings are used to assess the regulatory and quality compliance of a product commercially available for procurement on behalf of our clients.

Please download PFSCM’s Non-Pharmaceutical Products Prequalification Guide for Suppliers here. Vendors are encouraged to familiarize themselves with the prequalification steps are explained in this document.

Supplier Audits

PFSCM conducts audits to ensure the suppliers’ proposed products meet our quality standards. These audits are done in accordance with the WHO MQAS, and includes documentation reviews, product dossier reviews, and site visits to assess a supplier’s adherence with current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP). 

Quality Management System

All our services comply with our ISO 9001:2015 certified Quality Management System (QMS). We received our ISO 9001:2015 certification in November 2017, and we were 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. Our QMS is compliant with the WHO-MQAS.

 

PFSCM upholds the key global principles of a QMS:

3

Customer Satisfaction

2

Customer Satisfaction

A fundamental principle of ISO 9001:2015 is to continuously improve customer satisfaction by meeting and exceeding customer expectations.

3

Process Integration

2

Process Integration

The ISO process approach helps organizations to identify areas where efficiency and cost savings can be improved.

3

Evidence-based Decisions

2

Evidence-based Decisions

Through ISO 9001:2015, the organization commits to making decisions based on accurately analyzed data and facts.

3

Continuous Improvement

2

Continuous Improvement

ISO 9001:2015 requires an organization to continuously improve the adequacy, and effectiveness of its QMS.

Customer Satisfaction

A fundamental principle of ISO 9001:2015 is to continuously improve customer satisfaction by meeting and exceeding customer expectations.

Process Integration

The ISO process approach helps organizations to identify areas where efficiency and cost savings can be improved.

Evidense-based Decisions

Through ISO 9001:2015, the organization commits to making decisions based on accurately analyzed data and facts.

Continuous Improvement

ISO 9001:2015 requires an organization to continuously improve the adequacy, and effectiveness of its QMS.

Please send an email to sourcing@pfscm.org if you are interested in becoming a PFSCM supplier.

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