After the new update of ISO 13485, which entered into force in March 2016, Deltalab decided to adapt to it immediately and implement it with the maximum speed during the first half of 2017, without benefit from the period allowed adaptation three years, that is, until March 2019, for companies certified with the previous regulations.
ISO 13485: 2016 has been updated to accommodate changes to ISO 9001. The new version makes it more incisive in compliance with regulatory requirements, risk management, subcontractor control, process validations, equipment and validations of computer systems.
That is why we are pleased to inform you with great satisfaction that Deltalab has become the first company certified by SGS in Spain according to the new ISO 13485: 2016.
In turn, Deltalab has also successfully passed the certification of the new ISO 9001: 2015, proof of the willingness of the company to adapt to the new standards with utmost diligence.
Both audits took place the past 17, 18, 19 and 20 of July and Deltalab has already received the new certificates.