• Evidence of adherence to legal and regulatory or contractual requirements
• Minimize and manage risks
• Emphasize competence
• Error prevention instead of error correction
• Improved performance quality
• Customer and employee satisfaction
• Transparency and clarity of internal processes
• Time and cost savings
• Realization of quality policy and company goals
• International harmonisation - ISO 13485 promotes harmonisation of regulatory requirements for manufacturers of medical devices on an international scale. A number of countries have incorporated ISO 13485 into their regulatory systems. Compliance with ISO 13485 can be used in support of regulatory compliance.
• ISO 9001 quality - It incorporates many of the quality management principles and delivers the benefits of an ISO 9001 based quality management system.
ISO 13485 certification from Oxford Cert Universal enables you to:
• Provide evidence that you have met all statutory requirements relating to medical devices
• Increase the safety of your products and production processes
• Work in accordance with an internationally recognized standard
• Improve your competitive position
• Use our certification mark in your advertising to highlight product safety and quality
Oxford Cert Services
• Certification - Oxford Cert offer assessment and certification against ISO/TS 16949.
• Internal AuditAssessments - Oxford Cert offer gap analysis, preliminary assessments to prepare you for certification.
• Training -Oxford Cert offer training which will prepare you and your staff before and after the certification process.