According to the latest publication of ISO of statistics on certifications, the number of certified ISO 13485 companies far exceeded the 27,000 certifications worldwide with an increase of 8% and the norm in Spain had grown by more than 40 % of new certifications in just one year, reflecting the strength and well received this certification.
ISO standards are periodically revised to incorporate improvements and thus enhance and contribute to greater effectiveness of management systems certified companies.
The ISO 13485 Medical Devices. Quality Management Systems. Requirements for regulatory purposes is no exception and after publication in February 2016, certified companies have three years to adapt their system to the new requirements. This ISO 13485 enables companies to demonstrate compliance with regulatory requirements.
Some of the improvements established in this new version include:
- Risk Management processes and outreach activities Quality Management System.
- Compliance with regulatory requirements throughout the supply chain.
- Strengthening or greater clarity in some of the requirements such as customer feedback, software validation, control of suppliers, among others.
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