The standardized quality management system known as ISO 13485 is used by producers of medical devices, their suppliers, and other third parties who offer goods or parts of goods, as well as corporate services linked to QMS. Based on ISO 9001, ISO 13485 Certification adds additional requirements for structure, special procedures, environmental control, delectability, documenting records, and administrative tasks.
In contrast to ISO 9001, which calls on organizations to demonstrate continuous improvement, ISO 13485 only asks that a business demonstrate that a high-quality framework is implemented and maintained.
WHO MAY OBTAIN ISO 13485 CERTIFICATION?
The ISO 13485 Certification may serve as evidence that an organization’s Quality Management System complies with industry standards for the Medical Device sector. Along with other supporting entities like subcontractors, suppliers, European Authorized Representatives, specialized consulting firms, etc., medical device manufacturers also adhere to this strategy.
It should be noted that ISO 13485:2016 broadens the scope of businesses and organizations to which the quality can be applied, including those involved in one or more stages of the lifecycle of a medical device or suppliers or other external parties that provide goods to such organizations
THESE ARE THE MAIN UPDATES TO ISO 13485:2016
- The standard’s provisions have a stronger focus on risk, necessitating a greater senior management involvement in the quality management system.
- Added supplier controls, such as risk-based controls
- Additional guidelines for management reviews
- Combining training requirements with competency requirements
- An expert in software requirements
- Preclinical and clinical assessments are used to validate
- Verification of the requirements for packaging and distribution
- A section with suggestions, including a new section for resolving complaints and additional
instructions for customer communications - Additional steps for improvement include using post-market surveillance, risk-based choices,
and deadlines.
Advantages of ISO 13485
● The development and awareness of administrative requirements as a responsibility of the administration.
● Controls to ensure the safety of the products within the workplace.
● During development, put an emphasis on risk management and style control efforts.
● Specific requirements for implantable devices’ inspection and detectability.
● Specific requirements for documentation and certification of clean medical device processes.