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ISO 9001:2008

AS9100 Aerospace

AS9110 Maintenance/Overhaul

AS9120 Aerospace Requirements for Stocklist Distributors

TS16949 Automotive

AS13485/13488 Medical

AS13485/13488 Medical

Does your Company need ISO13485 or ISO 13488?


What is the difference between ISO 13485 and ISO 13488?

ISO 9001 is a quality system standard applicable to many different types of businesses. ISO 13485/13488 are standards specific to medical device quality systems that supplement the ISO 9001 standard. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, records retention, and regulatory actions, which are more critical for the medical device industry. ISO 13485/13488 are very similar to the European Standards EN 46001/46002, but do contain some additional requirements.

ISO 9001 / ISO 13485 — Who is certified to these standards?

Medical companies who intend to export their products to the global market will find this standard advantageous and Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 or ISO 13488 after January 2003.

US manufacturers that are in compliance with the FDA Quality System Regulations can assume that their quality system is close to meeting the requirements of the ISO 9001/ISO 13485 standards.

Let one of our professionals advise you on the different standards and give options as to how you may want to proceed based on the company's business objectives.