Next March 2019, the transitional period for medical device companies to comply the new ISO 13485 standard will end.

What are the differences between the EN ISO 13485:2012 and the ISO 13485:2016 standards? What are the new requirements? How to comply?

The driver behind the new version of the ISO 13485 standard is the promotion the world-wide harmonization of regulatory requirements as imposed by national standards.  The changes are based on developments in quality management systems, European and international legislation, and technology progress. The main changes include:

  • attention to the whole life cycle of the product/service: design, production, logistics, installation and maintenance
  • stricter controls throughout the supply and distribution chain
  • focus on the risk management system
  • higher specificity of the requirements in the design phase
  • attention to the post-market phase, in relation to the management of complaints and surveillance.

Why certify your QMS according to the ISO 13485 standard?

The ISO 13485 standard specifies the requirements for a quality management system for manufacturers to develop and demonstrate a  company production system  that ensures the safety and quality medical of devices.  The standard also provides companies with a useful tool to improve their internal processes for efficiency and performance. ISO 13485 certification is the evidence of the company’s ability to provide medical devices and services that meet market standards and regulatory requirements.

What will manufacturers have to do to comply with the new EN ISO 13485:2016 and get the QMS certification?

The new version of the international quality management standard for the medical device industry replaces the previous EN ISO 13485:2012 and, from March 2019, certifications in accordance with EN ISO 13485:2012 will no longer be considered valid. Companies certified to ISO 13485 must update their QMS to the requirements of the new standard, through:

  • a specific training to understand the main changes and acquire the necessary skills,
  • a gap analysis of the processes and policies for compliance to the previous standard and those needed for compliance to the new standard
  • a plan for transition and implementation to ensure compliance with the new requirements.

In addition, it is necessary to plan an audit, in order to assess the conformity to the new standard and obtain Notified Body certification to EN ISO 13485:2016.

For companies not currently ISO 13485 certified, they will have to set up their quality management system in order to meet the requirements and start the certification process with an accredited certification body.

ECM (Ente Certificazione Macchine), is a Notified Body accredited for EN ISO 13485:2012 standard. ECM is also accredited, by Accredia, for the certification of Quality Management Systems to EN ISO 13485:2016 standard. We support companies in the complex transition process by performing all the services required for the issuance of certification of compliance to this standard.

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