ISO 13485 Certification 101

A global federation of national standards organizations (ISO member bodies) exists under the name ISO (the International Organization for Standardization). Technical committees within ISO are often used to produce International Standards. The right of representation on a technical committee exists for any member body interested in a specific topic for which one has been created. All Governmental and non-governmental international groups collaborate with ISO to complete the task. On all issues relating to electro-technical standardization, ISO works closely with the International Electro-technical Commission (IEC). 

According to ISO 13485:2016, an organization must be able to supply medical devices and associated services that consistently fulfill the demands of the customer and relevant regulatory requirements. One or more steps of the life cycle, such as the design & development, manufacture, storage, distribution, installation, or maintenance of a medical device may be included by such companies. ISO 13484:2016 is also applicable to the distributor or third parties regarding their management system that manufactures medical equipment.

Except as specifically indicated, the requirements of ISO 13485:2016 apply to all companies, regardless of size or kind. Wherever standards are listed as applying to medical equipment, they also apply to related services provided by the organization.

The procedures that the organization must follow by ISO 13485:2016 are carried out by the organization and must include monitoring, maintaining, and controlling by the organization’s management system. The organization is not just following and maintaining those settings but also accountable for them.

The design and development controls from the quality management system may be removed and justified only when the relevant regulatory requirements accept such exclusions. After exclusion, the organization will follow the alternative approaches given by the regulatory authority to maintain a quality management system. The organization must make sure that any omission of design and development controls is reflected in claims of conformance to ISO 13485:2016.

The organization does not have to include the requirement in its quality management system if one in Clauses 6, 7, or 8 of ISO 13485:2016 does not apply to them because the tasks performed by the organization or the characteristics of the medical device do not need such clauses to maintain in the quality management system. Organizations must give justification for, not including any clause.

The certified organization must show that the quality system is correctly established and maintained, according to ISO 13485.

Specific standards for inspection and traceability for implanted devices; controls in the workplace to guarantee product safety; emphasis on risk management activities and design control activities throughout product development.

  • Precise guidelines for the validation methods used to create sterile medical devices.
  • Certain specifications for confirming the efficacy of remedial and preventative measures.
  • Particular specifications for product cleanliness

Peak Surgicals adhere completely to the recommended standards by the FDA and have an ISO 13485 certification. Every step of our manufacturing and production processes is tracked and well recorded. We are glad to say that our surgical instruments are 1st Grade German Forged and go through several quality inspections. Before selling to our valued customers, we at Peak Surgicals make sure that the quality, patterns, and style are constant.

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