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Medical Device Manufacturing

Quality System

World-class quality with every product and service we deliver. All Orchid divisions are certified to the requirements of ISO 13485:2003 and meet the requirements of FDA Quality System Regulations 21 CFR 820 as applicable. A shared commitment to meet or exceed our customer’s requirements ensures that these standards are maintained at every level or our organization.

The Orchid Quality Policy is our promise to you: “The Orchid Team is committed to complete customer satisfaction. This commitment and our core values guide us as we comply with our quality management system and drive continuous improvement in the ways we serve our customers.”

Quality Planning
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 Comprehensive quality plans developed through robust New Project Implementation program  
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 Risk assessment and mitigation (pFMEA) for all phases of process  
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 Statistical analysis used to ensure that all processes are capable  
     

Quality Inspection
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 State-of-the art inspection facilities and equipment  
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 In-house mechanical and metallographic lab testing  
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 Continuous training programs for quality personnel  
     

Continuous Improvement
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 Analysis of common quality metrics drives improved performance  
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 Best practices are identified and implemented throughout the organization  
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 Internal, customer and registrar quality system audits ensure compliance with standards  
     

Team Certifications
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 Certified Quality Engineers (CQE)  
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 Certified Quality Auditors (CQA)  
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 Certified Quality Technicians (CQT)  

 

 

  
 
 
 
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