SI ISO 13485: 2016: Medical devices - Quality management systems - Requirements for regulatory purposes

Law agencies, government, and large medical companies require that their suppliers comply with the specifications of SI ISO 13485

On whom the standard applies

The standard is applicable for organizations that develop, manufacture, install, distribute, or provide service for medical devices, and it includes most of the US Food and Drug Administration (FDA) requirements. Recognition of the Standards Institution of Israel mark of compliance with SI ISO 13485: 2016: Medical devices — Quality management systems indicates that the organization is taking the necessary measures to realize its product quality obligations.

Establishment of a quality management system pursuant to the requirements of ISO 13485 will enable the organization to:

• Collect and analyze metrics and targets for improvement
• Comply with the contractual requirements in the market, and supply the products to markets
• Drive processes and plans for continuous improvement (including beyond basic compliance to the specifications)
• Switch to effective and efficient work processes
• Provide consistency throughout the production chain from the level of materials to the level of the finished product

Standards Institution of Israel auditors will help identify whether the organization's quality management system is in compliance with the requirements of SI ISO 13485 and what are the points in need of improvement. .

The Quality Certification Branch has ISO 13485: 2016 accreditation from the Dutch Accreditation Council (RvA).

 The Standards Institution of Israel is prepared to issue certification for active production categories (products that require an energy source) and non-active category products (products that do not require an energy source). It is also possible to certify organizations that do not manufacture a finished product, such as subcontractors, raw material producers, distributors, and shippers. It is possible to use Standards Institution of Israel laboratory tests to prepare the technical file.

The road to certification

Certification follows the successful implementation an organization's in-house quality management system pursuant to the requirements of the standard. To start this process, it is recommended to purchase the standard at the Standards Institution of Israel Information Center, study the requirements, and participate in appropriate training.

The process ought to be seen as an opportunity for improvement via the organization team which will receive management commitment and involvement. At the end of the process, independent Standards Institution of Israel auditors will perform an audit that confirms that the organization's quality management system for medical devices is compatible to the specifications of the standard.