The latest edition of ISO 13485, the internationally recognised quality management systems standard for the medical device industry, with over 27,000 certificates globally, has been published on March 1, 2016.
ISO 13485:2016 identifies the requirements for a quality management system (QMS) in which an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet both customer and regulatory requirements.
This third edition cancels and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised. It also incorporates the Technical Corrigendum ISO 13485:2003/Cor.1:2009.
Some of the most critical changes in the 2016 version include:
The ISO 13485 standard was updated for two main reasons: to keep up with changes in the industry and to address changes in the underlying ISO 9001 standard. While the old ISO 13485 2003 standard was based on the old ISO 9001 2000 standard, the new one is based on ISO 9001 2008. While some people expected the new ISO 13485 standard to use the latest ISO 9001 2015 standard, ISO TC 210 evidently feels that the older ISO 9001 standard better serves the needs of medical device suppliers, regulators, and customers.
Please fill out the Questionnaire or contact us if you need our hands to assist you in developing and establishing your management system in compliance with the requirements of ISO 13485:2016 standard. We also offer a gap assessment service to find out how close you are to your ISO 13485:2016 certificate.
We have professional consultants in all states who are assisting you with implementing and improving your management systems, including ISO 9001, ISO 14001, ISO 45001, ...
Read MoreWe offer Internal Audit and Gap Analysis services where we plan, conduct and manage the audits on your behalf by professional, experienced and knowledgeable ...
Read MoreOnce you achieve your certificate, you will face a new challenge for maintaining what you have achieved as every year your certification body comes back for a surveillance audit ...
Read More