ISO 13485 certificate & ISO 13485 consultants for ISO certification. ISO 13485 certificate consultants and training in India


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ISO 13485

ISO 13485:2003 (Medical devices - Quality management systems - Requirements for regulatory purposes) is essentially ISO 9001 adapted to meet the requirements of the medical device industry and it addresses most FDA requirements (21CFR820). The main difference between ISO 9001 and ISO 13485 is that ISO 13485 is more focused towards ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement.

ISO 13485:2003 - Medical devices -- Quality management systems -- Requirements for regulatory purposes specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.

Who is it applicable to?
  • Companies, who design, manufacture, distribute, install and service medical devices for the European and World markets.
  • Companies who manufacture OEM products, which are sold under other, company names.
  • Companies who design and/or manufacture medical device components or raw materials for the medical device market.
  • Companies selling, installing or servicing medical devices.
  • Consultants providing design services to the medical device market.
  • Companies providing services to the medical device market such as sterilisation, cleaning, testing, etc
ISO 13485 Benefits of Certification

For manufacturers of medical devices who want to provide safe/effective equipment,   a proper Quality Management System (QMS) needs to be in place in order to comply with regulatory requirements.  Since 2003 when ISO 13485 was first implemented and recognized by the Global  Harmonization Task Force,  it has quickly become the model standard for the medical industry.

By becoming certified in the ISO 13485 standard your company will:
  • Increase the probability of making safe and effective medical devices
  • Meet regulatory requirements
  • Meet customer expectations
  • Help monitor the effectiveness of your supply chain
This standard is recognized by most major markets around the world (United States of America, Europe, Canada, Japan, and Australia) and more major markets are likely to adopt this standard.  With ISO 13485 certification you will be able to enter any major market around the world with one audit!
By becoming ISO 13485 certified your company’s Quality Management System (QMS) will be in line with the Food and Drug Administration’s (FDA) QSR standards.

Additional Benefits of ISO 13485 certification:
  • Increased Efficiency
  • Cost Savings
  • More Effective Risk Management and Quality Assurance
  • Improved ability to respond to Customer Requirements
How can Consultants - India help you to achieve ISO 13485 Certification?

Consultants - India will assist your organization in SA 8000 awareness training, documentation, implementation, internal auditing and overall process optimization as per ISO 13485 standard. Consultants - India is a result oriented professional training and certification service providers, offering systematic approaches to improve quality and effectiveness of the system and enhance the productivity by offering systematic approaches. Our main objective is to help you and your organization improve profitability, through better utilization of all of your resources.

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ISO 13485 certificate Consultants for ISO 13485 certification QMS in India, Agra, Hyderabad, Delhi, bangalore, Mumbai, Thiruvananthapuram, Calcutta, Ahmedabad, Jaipur, Chennai, Pune. Consultants for ISO 13485 standards, ISO 13485 implementation, ISO 13485 training, ISO 13485 documentation and ISO 13485 certification in India.
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