Dqs iso 13485

Software-Validation was now clearly addressed. Some requirements, e. Risk Management now covers a company-wide approach. Further on the standard demands to document the Rolls and Function s of the organisation.

More specific input and output aspects of Management Reviews were added, same as additional documentation requirements for the Work Environment , Contamination Control of sterile medical devices and labelling. The level of focus on Reporting Procedures was emphasized. On the other hand it is an advantage, that the new ISO kept the established structure.

Request a quote. Request a call. Request information. Checklist Our Services System certifications What is Certification? Why certification? Who is concerned by certifications in the healthcare system? A risk management procedure according to ISO has to be introduced.

Validations are also required for production and testing software, if such software has an influence on product quality. Kalavriton 4 , Kifisia 62 33 — 62 33 62 33 62 33 info dqs. ISO Home ISO Certification Profile This standard is addressed to medical device manufacturers as well as suppliers and service providers who have to comply not only with international, European or national legal requirements, but also with corresponding requirements of customers.

Enterprises that want to develop and manufacture medical devices and place them on the market. Service providers and other suppliers within the value-added chain.