ISO 13485:2016
Medical Devices and Related Services Quality Management System
QLC’s ISO 13485 certification consultants answer your questions
ISO 13485 is an international standard developed by the International Organization for Standardization (ISO). It specifies the general requirements for a quality management system that organizations must meet to demonstrate their ability to provide medical devices and related services that comply with customer and applicable regulatory requirements. ISO 13485 is based on ISO 9001, and many of the requirements in these two standards overlap.
It applies to all businesses involved in the design and development, production, marketing, installation, and maintenance of medical devices, regardless of their type and size.
The development of the quality management system follows these phases:
- Identifying the legislative requirements for the products/services provided and for the business’s operations
- Determining how to correct potential deviations
- Evaluating the compliance of existing processes and records with the standard’s requirements
- Revising existing processes and records where deviations from the standard’s requirements exist, and introducing new processes and records where there is a complete absence
- Training staff on the system’s requirements
- Implementing the system
- Reviewing and modifying the system as needed
- Conducting an internal audit
Several factors influence the degree of difficulty in implementing the system, such as the type of business activity, the number and categories of its products, the complexity of its processes, and how familiar the staff is with following a management system. Collaborating with a specialized consultant is considered crucial to develop a functional and effective system tailored to the business’s needs that meets the standard’s requirements.
ISO 13485 can also be combined with other standards the organization applies or intends to apply, enabling the establishment of a unified management system.
Notified Bodies in the field of medical devices are responsible for certifying businesses according to ISO 13485. The certification process includes evaluating the organization’s compliance with legislative requirements regarding its operations and the products/services provided, assessing the management system against the standard’s requirements, and evaluating the system’s implementation.
After successfully completing the assessment, the Notified Body issues a Certificate of Conformity valid for three years. In the case of significant deviations, corrective actions must be carried out by the business before the Certificate can be issued. For minor deviations, corrective actions must be completed before the next assessment.
The Certificate remains valid as long as scheduled periodic assessments are carried out by the Certification Body at least once a year, confirming ongoing compliance with the specified requirements.
Most organizations choose to certify to ISO 13485 due to the need to comply with regulatory requirements governing medical devices. Additionally, organizations may benefit from:
- Organizing departments and standardizing processes to reduce errors and failures
- Improving staff performance
- Enhancing the reliability of provided products and services
- Developing business partnerships with customers or suppliers who prefer to work with ISO 13485-certified companies
- Gaining eligibility to participate in public tenders where ISO 13485 Certification is part of the required documentation
The required time for developing the system and achieving certification varies for each business, depending on factors such as size, organizational level, the degree of compliance with legislative requirements, and staff involvement. For small businesses that already meet the legislative requirements, the timeframe typically ranges from 1 to 4 months.