Being ISO 13485 certified helps build business and employee confidence, an essential requirement in the medical device manufacturing industry. ISO 13485 has become the globally accepted standard in the medical manufacturing industry and certifies compliance with regulatory requirements. Industry organizations are expected to provide evidence of the implementation of the quality management system throughout the production cycle. That is why it is so important to obtain the ISO 13485 certification.
ISO 13485 certification guarantees compliance with international standards in all phases of the life cycle of medical devices: design, manufacturing, installation, technical support and sales. This QMS standard also covers other aspects of post production, such as storage, distribution and the provision of associated services. Also, the disposal and dismantling of used or damaged medical devices is regulated by this ISO standard.
This standard is based on the ISO 9001 QMS standard, adapted for the medical device manufacturing environment. Being certified to both standards ensures competitiveness, transparency, effectiveness, and will only bring more confidence to potential business partners.
For manufacturers, certification means greater market access. Being able to work with a global network of potential customers and business partners is one of the main reasons any business should apply for certification. National and international regulatory authorities prefer manufacturers with a third-party audited and certified quality management system. Investing in such a system speeds up access to those countries that require it. Expanding production or sales operation to a new country with this QMS is difficult and in some cases impossible.
Investing in the implementation and recognition of ISO 13485 has the potential to save a lot of money. First of all, by providing proof of compliance with high quality standards, the search for potential clients takes much less time. All large companies that buy medical equipment require credibility and commitment to qualify for all business partners.
Although this standard does not emphasize the need for continuous improvement, strictly aiming to meet quality requirements and achieve customer satisfaction, by implementing it the company will obtain process control that will allow it to continue developing and improving.
The latest version of this ISO further highlights the need for effective risk management and risk decision management. Risk management for any medical device must be fully documented and applied throughout the entire life cycle of any product. Demonstrating that the risk was fully understood and documented will help companies achieve not only ISO 13485, but also ISO 14971, which is the ISO standard for the application of risk management to medical devices.