ISO 13485:2016
ISO 13485:2016
ISO 13485:2016 for Medical Devices (Quality Management Systems) – Requirements for Regulatory Purposes, specifies quality management system requirements that can be used by organizations for the design and development, production, installation, and servicing of medical devices, as well as the design, development, and provision of services related to medical devices.
ISO 13485:2016 can be applied independently; however, as it is derived from the ISO 9001 standard, it can also be applied in conjunction with it. Therefore, quality management system certificates can be issued for compliance with ISO 13485 alone or jointly with ISO 9001.
The ISO 13485 standard specifies requirements for a quality management system when an organization needs to demonstrate the ability to provide medical devices and related services that meet regulatory requirements and customer expectations.
The primary goal of the ISO 13485 standard is to facilitate the harmonization of regulatory requirements for medical devices with the quality management system. As a result, there are some specific requirements for medical devices that cannot be addressed by the requirements of the ISO 9001 standard.
Implementation and certification of compliance with the ISO 13485 standard bring about several benefits, such as:
Enhancement of the organization's image as a reliable trading partner operating in accordance with international standards' requirements.
Improvement of competitiveness in the market offering.
Ensuring stability and repeatability of processes through their systematization.
Ensuring and maintaining order within the organization by defining procedures, methods of operation, responsibilities, and authorities.
For entities that have previously operated under a Quality Management System based solely on the ISO 9001:2015 standard, difficulty may arise in identifying the exclusions from its application as mentioned above. Due to these exclusions, organizations whose Quality Management System complies with ISO 13485 cannot expect compliance with ISO 9001 unless their quality management system meets all ISO 9001 requirements.
eCValidation offers comprehensive consulting services in this regard, including:
- Comprehensive assistance in handling formalities with the Notified Body.
- Preparation for certification by the Notified Body.
- Development of required quality documentation necessary for Certification by the Notified Body (Quality Policy, Quality Manual, procedures, and instructions).
- Conducting audits to assess the entity's readiness for certification by the Notified Body.
ISO 13485:2016 implementation
Our approach begins with collaborative workshops where we gain a deep insight into the organization’s processes. By analyzing current practices, we create a personalized roadmap and scope of work for the successful implementation of the Quality Management System.
Throughout the entire certification process, our team provides continuous support, ensuring that the organization is adequately prepared for audits and certification. We guarantee a positive outcome of the compliance audit.
We encourage you to engage in a partnership with eCValidation to achieve comprehensive implementation of the quality management system and experience the multitude of benefits it brings.