Quality PolicyThe management and employees of Affinity Biologicals Inc. endeavour to design, produce and distribute quality products. Affinity Biologicals Inc. will maintain a documented quality system in accordance with ISO13485:2003 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 customerâ€™s needs. The regulatory requirements of Canada (CMDR, Canadian Medical Device Regulations), the United States (21 CFR part 800-861 and 864), Europe (in vitro Diagnostic Directive 98/79/EEC) and India (Indian Central Drugs Standard Control Organization (CDSCO) will apply to in vitro diagnostic products only. 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.
ValuesThe values that drive the activities of Affinity Biologicals are:
- A commitment at all levels to the continuous improvement of our quality system, our manufacturing processes and our business practices. We will always endeavor to provide world-class products and enhance customer satisfaction.
- Teamwork. We will benefit from the increased potential of individuals working together to solve problems and generate new ideas.
- A commitment to creating a positive work environment, where individuals are encouraged to develop professionally and personally through continuous learning, and where performance is recognized and rewarded.
- Integrity. We will always conduct our business and manufacturing practices in an open and ethical manner. We treat our customers, our coworkers and our suppliers with respect.