ISO 13485: Medical devices – Quality management systems requirements for regulatory purposes

ISO 13485: Medical devices – Quality management systems requirements for regulatory purposes

The Global quality services (GQS) is the leading consulting firm for offering the proper and appropriate ISO certification consultations for the medical device manufacturers. Before getting your medical devices certified under the ISO 13485, it is very essential to know about the ISO 13485 certification. It usually specifies the requirements for a Quality management system (QMS) that can be used by an organization involved in one or more stages of the cycle of a medical device. This also includes design and development, production, storage and distribution, installation, servicing, final decommissioning, and also the disposal of the medical devices. The ISO 13485 certification of the medical devices is not only restricted to the medical device manufacturers, but can also be used by other external parties providing the product,

  • Raw materials
  • Components
  • Subassemblies
  • 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

The Global quality services will offer you the best consulting services based on any ISO certifications and this ISO 13485 is based on a process approach to quality management.

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