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Systems Consulting, Health Care & Medical Devices
ISO 13485:2003

ISO 13485 is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of medical devices. This standard can also be used by international and external parties, including certification bodies, for assessment of the organization's ability to meet customer and regulatory requirements. The quality management system requirements specified in the ISO 13485:2003 standard complements technical requirements for products. The primary purpose of the ISO 13485:2003 standard is to facilitate harmonized medical device regulatory requirements for quality systems. All requirements of the ISO 13485:2003 standard are specific to organizations providing medical devices, regardless of the type or size.

  • What is ISO 13485?.

    ISO 13485, published in 2003, and now fully recognized in many countries, is based on the ISO 9001 process model approach.  These standards provide a good base model, recognized by the Global Harmonization Task Force (GHTF), for compliance with the European Union (EU) CE marking medical device directives, Health Canada CMDCAS, Taiwan Medical Device Regulations, Japan JPAL and other international requirements.

    Certification to ISO 13485 takes place when an accredited third party, such as BSI, visits an organization, assesses the quality management system and, if satisfactory, issues a certificate confirming that the organization’s quality management system meets the requirements of the standard.

  • Which organizations can implement ISO 13485?

    ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

  • What are the Advantages of  ISO 13485?

    Gaining certification to ISO 13485 through BSI will help your organization do business in this highly regulated sector. Whether you are looking to operate internationally or to expand locally to accommodate new business, ISO 13485 will help you demonstrate to customers and regulators that you are committed to quality.
    The regular assessment process will ensure that your processes are continually checked for effectiveness and provide the opportunity to avoid unpleasant regulatory surprises. Certification can improve overall performance, remove uncertainty and widen market opportunities.

  • Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
  • Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
  • Improved stakeholder relationships - including staff, customers and suppliers
  • Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
  • Improved risk management - through greater consistency and traceability of products and use of risk management techniques
  • Proven business credentials - through independent verification against recognized standards
  • Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector
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