ISO 13485: Medical devices – Quality management systems requirements for regulatory purposes
- Raw materials
- Medical devices
- Sterilization services
- Calibration services
- Distribution services
- Maintenance services
Hence, the supplier or the external party can voluntarily choose to conform to the requirements of this ISO 13485 certification or can be required to contract to conform. The exact definition and understanding of this ISO 13485 certification differs from nation to nation and region to region. The important thing to be noted is that the concerned organization must need to know how such definitions related to the ISO 13485 certifications will be interpreted in light of the regulatory definitions in the jurisdictions in which the medical devices are made available. The other thing that is made into consideration is that the Quality management system (QMS) specified in the ISO 13485 certification are complementary to the technical requirements for products that are necessary to meet customer and also the applicable regulatory requirements for safety and performance.
But the concerned organization must take strategic decision to adopt the quality management system for offering the ISO certification for medical devices. It is not the intent of ISO 13485 to imply the need for uniformity in the structure of Quality management system (QMS) or the uniformity of documentation or alignment of documentation to the proper clause structure of ISO 13485.
ISO 13485 certification is not about the business requirements or the initiatives that includes financial or environmental requirements. It also does not define the requirements of products and services provided by the organization.
Where does ISO 13485 come from?
The ISO 13485 is made by the ISO/TC 210 which is the quality management and corresponding general aspects for medical devices and it is established in 1994. There are certain references and title under this ISO/TC 210 and some include:
ISO/TC 210/JWG 1 – Joint ISO/TC 210-IEC/SC 62A WG: Application of risk management to medical devices
ISO/TC 210/JWG 2 – Joint ISO/TC 210-IEC/SC 62A WG: Medical device software
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