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SI ISO 13485 - Madical Devices- Quality Management System (QMS) - Requirement for Regulatory Purposes

 
Government authorities and major companies in the field of medical devices, require their suppliers to be ISO 13485 certified.
The standard is intended for organizations that develop, manufacture, install, distribute or provide service for medical devices. It includes the majority of requirements from the American FDA. Certification by the Standards Institution of Israel that an organization’s quality management system meets the requirements of ISO 13485, confirms that the organization takes the necessary steps to realize its commitment to the quality of its products.

Creating a quality management system based on the requirements of  ISO 13485 will enable the organization to:

 
  • Collect and analyse of metrics and goals for improvement.
  • Comply with contractual requirements of the market, enable to deliver the products to these markets.
  • Drive ongoing processes and plans for improvement (even beyond basic compliance to the requirements).
  • Implementation of effective and efficient work processes.
  • Trace across the entire supply-chain from basic materials, to finished product.


Auditors from the Standards Institution of Israel will  verify compliance of  the organization’s quality management system  of the medical devices to the requirements  of ISO 13485 Standard , and will point out where improvements are necessary. Certification according to ISO 13485 also indicates that the organization meets the requirements  of ISO 9001 with minor additions.

The path to certification

Certification is done after implementation of an intra-organizational process, in which the organization’s quality system, has been successfully implemented. In order to start the process, it is recommended to purchase the standard at the Standards Institution information center, to learn the requirements and to participate in appropriate training. Additionally, consultants that specialize in quality management system in the field of medical devices can be used.  The Standards Institution of Israel can conduct a preliminary audit to identify gaps.
The process should be considered as an opportunity for improvement and should be leaded by a team from the organization  which will receive support and involvement of the organization's management. At the end of the process, independet auditors of the Standards Institution of Israel will perform the audit that confirms that the organization’s quality system is appropriate.


Required Steps


The Client The Standards Institution of Israel
Registration with the Standards Institution of Israel. If CE is  required, also with an European entity Sending a bid that includes: Checking procedures and Stage 1 Audit (preliminary), Stage 2 Audit (Certification)
Approval of the quotation/ Payment of invoice Assignment of a Lead Auditur
Submission of the Quality Manual and procedures Review of documentation, coordinating and performing Stage 1 and Stage 2 Audits
Dealing with findings of the audits and fixing discrepancies Review and approval of corrective actions (by the Lead Auditor), professional and administrative approval, sending surveilance agreement (for surveillance audits)
Signing surveilance agreement Sending certificates and agreement signed by The Standards Institution of Israel
Activities to continually improve quality Performance of surveillance audits to verify organization’s compliance to requirements
 

The Standards Institute of Israel cooperates with  various European Certification Bodies (Notified Bodies) and enables it's clients to choose the European entity which will provide the  CE authorization for their products. It includes  Active and Non-Active devices as well as also approval for  the Canadian authorities, in accordance with requirements of CMDCAS. Laboratory tests to as required  for the technical file can also be done in the SII laboratories.

The Standards Institution of Israel – the right choice for you

 
  • The Standards Institution of Israel has a long standing reputation in quality and professionalism.
  • Our people are among the leading professional experts in the field of quality, having experience and are familiar with client needs.
  • The Standards Institution of Israel is the largest Certification Body in Israel.
  • The Standards Institution of Israel is accredited by RvA, one of the world’s largest accreditation bodies.
  • The Standards Institution of Israel provides a range of services under one umbrella: Certification, various laboratory tests and training.
  • The Standards Institution of Israel is a member of international Standards Committees and has cooperation agreements with leading entities around the world.
  • The Standards Institution of Israel is Israel’s representative in the IQNet network that incorporates Certification Bodies (C.B) from around the world.


ISO 13485 English Version has been published on February 2016.
A transition period of 3 years until February 2019 has been set.
Organizations must update their Quality Management System according to the requirements.



Contacts

For information:
Mr. Nathan Schuster
Mobile: ++972-52-2303039
E-mail: schuster@sii.org.il
 
For Registration:
Mrs.  Ofir Asher
Office: ++972-3-6467832
E-mail: ofir_as@sii.org.il