ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory purposes) is one of the international standards that regulate the quality of medical devices. It was first introduced in 1996 and then constantly improved, with the current effective edition published on 1st March 2016. Although the course of certification process may seem quite demanding as the implementation involves many requirements, such as Audit Zero (analysis od the company), a creation of an implementation schedule, training for managers and employees, execution of Internal Audit and much more, it is definitely worth the effort.
With ISO 13485 safety and performance of medical devices are regulated by the establishment of QMS practices and therefore medical device compliance with the regulation is demonstrated by the manufacturer. That leads to an increase in confidence to the manufacturer himself and improvement of his image and brand in the medical devices market, creating a certain prestige of the company. As the quality of services is higher, fewer amount of complaints occurs
Another important benefit coming from an implementation of ISO 13485 is an acquisition of a competitive advantage both in domestic and foreign markets. As ISO certification is not mandatory, it is easier to seal the deal while meeting one of the requirements of a tender specification which might be essential to a potential customer.
“Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.”
More detailed information about the certification itself can be found in an information brochure. For the ones interested in implementing this standard, the regulation can be found on the official website of ISO. It is also worth visiting a Guide to ISO 13485.