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.

Supplier Prequalifcation

For products not approved by these agencies, we conduct vendor prequalification audits to ensure the suppliers’ proposed products meet our quality standards. These audits are done in accordance with the WHO’s Model Quality Assurance System for Procurement Agencies (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). In the past ten years, PFSCM has conducted over 100 audits, and owing to COVID-19, also started doing remote audits.

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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