Our Commitment to Quality

The management and employees of Affinity Biologicals endeavor to design, produce and distribute quality products.

Affinity Biologicals will maintain a documented quality system in accordance with ISO 13485 and 21 CFR820 (Quality System Regulations). This system will identify and comply with the regulatory requirements for in vitro diagnostic medical devices as appropriate to meet our customer’s needs.

The regulatory requirements of Canada (CMDR, Canadian Medical Device Regulations) and the United States (21 CFR part 800-861 and 864) will apply to in vitro diagnostic products only.

View ISO 13485 and MDSAP Certificate

The following commitments support achievement of our quality policies:

  • Management is visibly committed to this quality policy.
  • Empower, educate and train employees to accomplish quality goals.
  • Identification, resolution, correction and prevention of quality problems.
  • Proactively establish and nurture customer relationships to stay abreast of market needs and opportunities.
  • Continuous effort to improve methods and processes.
  • Establish, communicate and monitor quality objectives.
  • Recognize quality achievements throughout the organization.
  • Form cooperative relationships with our suppliers to ensure quality products.
  • Comply with requirements and maintain the effectiveness of the quality management system.

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