ISO 13485:2003 Certification


The ISO 13485:2003 Standard is a quality management systems for Medical Devices Industry, including IVD (In Vitro Diagnostic). This standard can be used by a company for design and development, production, installation & servicing of medical devices as well as for the design, development and provision of related services. We provide ISO 13485:2003 certification services in Nepal.

Benefits of ISO 13485:2003

  • Improved Customer satisfaction - by meeting customer requirements as well as quality & legal requirements
  • Ability to get more business - particularly where procurement specifications require certification
  • Reduced operating costs - through continual process improvement & operational efficiencies
  • Improved risk management - through greater consistency and traceability of products
  • Improved stakeholder relationships - including staff, customers and suppliers
  • Legal compliance - by understanding how statutory and regulatory requirements
  • Proven business credentials - through independent verification
ISO 13485 certification is required for national and international business. This is also required in government tenders. Universal Quality Standards Registrar is playing a major role in providing audit services for ISO 13485:2003 certification in Nepal

Requirements of ISO 13485:2003 Certification Standard

ISO 13485:2003 certification standard is based on following principles :- Management commitment, Customer focus, Quality policy, Quality objectives, QMS planning, Deciding Responsibility & authority, Management review, Resource management, Product / Services realization, Measurement analysis and improvement.

ISO 13485:2003 Certification Process

Apply to UQSR with filled in application form - Application review & acceptance by UQSR - Stage one audit(document review audit) - Stage two audit(Process control audit) - Certification decision & issuance of ISO 13485 certificate - Surveillance audit to be conducted every year - Re - Certification after three years

Locations We Cover

ISO 13485:2003 Certification in Kathmandu, ISO 13485:2003 Certification in Biratnagar, ISO 13485:2003 Certification in Pokhara, ISO 13485:2003 Certification in Lalitpur, ISO 13485:2003 Certificationn in Bharatpur, ISO 13485:2003 Certification in Birganj, ISO 13485:2003 Certification in Butwal, ISO 13485:2003 Certification in Dharan, ISO 13485:2003 Certification in Dhangadhi, ISO 13485:2003 Certification in Bhim Datta.

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