Why ISO 13485?

The medical device industry is affected by a complex array of regulatory systems, national and international standards and other requirements. We provide services that help manufacturers understand what they need to do to place compliant devices on markets throughout the world.

Whatever devices you produce, as a medical device manufacturer you have a responsibility to consistently deliver devices that are safe and effective. ISO 13485 is the international standard recognized for medical device regulations around the world.

 Its primary objective is to facilitate harmonized medical device regulatory requirements.

The standard contains specific requirements for manufacture, installation and servicing and calls for:

  • Implementation of a Quality Management System with several enhancements
  • Risk Management approach to product development and product realisation
  • Validation of processes
  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems

What are the benefits of ISO 13485 certification?

  • 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
  • Improved risk management – through greater consistency and traceability of products and use of risk management techniques
  • Legal compliance – by understanding how statutory and regulatory requirements impact the organization and its customers
  • 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

For whom is ISO 13485 applicable?

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.

Why Choose Transpacific Certifications Limited for ISO 13485 Certification?

  • Transpacific Certifications Limited offers certification/registration services for ISO 13485 Medical Devices – Quality Management Systems, besides offering a range of other services like certification of Quality Management Systems as per ISO 9001, Environmental Management Systems as per ISO 14001, Food Safety Management Systems (including HACCP) as per ISO 22000, Information Security Management Systems as per ISO 27001, Occupational Health & Safety as per OHSAS 18001 etc.
  • TCL is a fast growing certification body possessing highly skilled and experienced human resources dedicated to provide quality services to our clients for achieving excellence in business. Our clients, numbering more than 10,000 bear a testimony to this.
  • TCL has the distinction of being one of the few organizations accredited by JAS-ANZ for all scopes of QMS, EMS, OHSAS, ISMS and FSMS in India, which means we can handle work of all categories and diverse industry types.
  • TCL is also accredited with National Accreditation Board for Certification Bodies (NABCB) for Quality Management Systems, ISO 9001.
  • TCL is one of the very few certification bodies in India permitted to use logo of IAF Logo (International Accreditation Forum Inc., World Association for Conformity Assessment) on the certificate as per agreement signed with them through AB.
  • TCL has a global presence. We have offices in various countries like Bulgaria, Egypt, Korea, Turkey, UK etc.

ISO 13485 Registration Process : Our Methodology

At Transpacific Certifications Limited our methodology for ISO 13485 registration/certification consists of the following steps:

  1. Signing of Contract
  2. Pre-audit (optional) to identify gap analysis of your current position against the standard
  3. Stage I Audit – Documentation Review
  4. Stage II Audit – Initial Certification Audit
  5. Issuance of Certificate
  6. Surveillance Audits to ensure maintenance of system and continual improvement
  7. Re-certification through full audit after 3 years for continual assessment

Note – The certification of ISO 9001 is a pre-requisite for the clients interested in applying for ISO 13485 certification.

For any type of query, please click here.