Overview of ISO 13485


ISO 13485, represents the requirements for a comprehensive management system for the design and manufacture of medical devices, with specific focus on product risk identification and traceability of the product.

Although seen as a stand-alone document, ISO 13485 most organisations generally combine it with the ISO 9001 standard.

The main difference when compared is that ISO 13485 focuses on proof that the system is implemented and maintained while ISO 9001 requires the organization to demonstrate entrenchment and continuous improvement.


Other specific differences between the two standards include:

  • the promotion and awareness of regulatory requirements as a management responsibility.
  • controls in the work environment to ensure product safety
  • focus on risk management activities and design transfer activities during product development
  • specific requirements for inspection and traceability of medical devices, including the availability of a product master file to specify detailed product characteristics.
  • specific requirements for documentation and validation of processes for sterile medical devices
  • specific requirements for verification of the effectiveness of corrective and preventive actions
  • ISO13485 is focussed on products whilst ISO 9001 can apply to both products and services

 

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. Local South Africa certification bodies are however still unable, at this stage, to provide accreditation against the CE mark.

Effective Quality Solutions will facilitate the review and documentation of internal processes against the requirements of the ISO 13485 standard to ensure compliance and improved internal efficiencies.

The system will be implemented and audited to verify compliance against the various detailed requirements including product and process controls.

We will facilitate the certification process with the relevant division within the SABS and assist with the clearance of any findings that are recorded.