SGI Analytical Technologies

Quality is never an accident,
it is always the result of intelligent effort.

ISO 13485:2003 Certification

ISO 13485:2003 Certification

What is ISO 13485?

ISO 13485 is an ISO standard, published in 2003, that represents the requirements for a comprehensive "management system for the design and manufacture of medical devices". While it remains a stand-alone document, "ISO 13485" is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained.

ISO 13485:2003 provides a harmonized set of quality management system requirements for medical device manufacturers. Based on a process approach to quality management, it focuses on what the manufacturer does to provide safe and effective medical devices.

Your ISO 13485 certificates can help you enter into EU market.

While it is based on ISO 9001:2008, ISO 13485 does not include the customer satisfaction and continual improvement clauses - so an organization certified to ISO 13485 does not automatically meet the requirements of ISO 9001 unless it is assessed against that standard separately. Compliance with ISO 13485 also does not equate compliance with regulatory requirements, although in many cases it can facilitate the audit process for those requirements.

Why should my organization become certified to ISO 13485?

Your quality system's conformity with ISO 13485 can help you reap the benefits of:

Other specific differences include:

Contact Us Today or send an Enquiry for your ISO Certification requirements.