ISO 13485 and ISO 9001 Quality Systems

ISO 13485 is the ISO standard for quality management systems specific to medical device and IVD companies. The most recent revision was issued in 2016.
The main objective of this update was to align ISO 13485 with the quality system requirements of key global markets, promoting global harmonization.

ISO 9001 is the ISO standard for quality management systems applicable to all types of companies. The latest revision was issued in 2015, following the High-Level Structure (HLS) approach.

Maytal can support any company seeking certification under these standards (e.g., manufacturers, importers, distributors of medical devices and IVDs) to:

• Implement a Quality Management System in compliance with ISO 13485:2016 or ISO 9001:2015 requirements

• Conduct internal audits and supplier audits for outsourced processes

• Assist the company during the certification audit