ISO 13485:2016 Medical Devices - Quality Management Certification

ISO 13485:2016 recognizes needs for a quality management system where an organization requirements to demonstrate its capability to offer medical devices and related services that persistently meet client and applicable regulatory needs. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by dealers or outside parties that deliver product, including quality management system-related services to such organizations.

The standard offers manufacturers, designers, and suppliers to the medical device industry with the framework necessary to demonstrate compliance to regulatory requirements, mitigate risks, and confirm best practices are taken for quality, safety, and sustainability.

Some of the biggest changes between the 2003 and 2016 version include:

• Incorporation of risk-based approaches beyond product recognition. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements;
• Developed connection with regulatory requirements, particularly for regulatory documentation;
• Application to organizations throughout the lifecycle and supply chain for medical devices;
• Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard;
• Force on correct infrastructure, particularly for production of sterile medical devices, and addition of requirements for validation of sterile barrier properties;
• Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design transfer and design records;
• Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, and consideration of post-market surveillance; and
• Planning and documenting corrective action and preventive action, and applying corrective action without undue postponement.

Benefits of ISO 13485:2016

• ISO 13485 certification helps in developing customer fulfilment and refining operational proficiency internal and external to the organization.
• ISO 13485:2016 Certification supports businesses entity win public and private contracts thus broadening the scope of potential clients.
• Companies that certified by ISO 13485 are considered more trustworthy by the consumers than the company that doesn’t have. Because the customers intensely believe that the company has a good QMS.
• ISO certification supports organizations in reducing wastage, expand working culture and make sure best practices, which helps in reducing the overall cost.