ISO 13485 Certification Quality Management System for Medical Devices

ISO 13485 Certification enlists the list of internationally recognized standards for the quality management of medical devices. It facilitates the processes from safe manufacturing to safe distribution of medical devices.

ISO 13485 certification aims at harmonizing the management system of your organization with the regulatory requirements. For those countries that export medical devices, it becomes obligatory to acquire ISO 13485 Certification in Kuwait.

Benefits of ISO 13485 certification:

  • Customer satisfaction
  • Reduced cost of operation
  • Improved relationship with the stakeholders
  • Compliance to legal obligations
  • Gives proven credibility to your business
  • Ability to win business in regulated sectors
  • Better risk management

The International Organization for Standardization (ISO) published the first edition of ISO 13485 in 1996. The standards are reviewed at least every 6 to 8 years to keep them updated. The updated version of ISO 13485 was first released in 2003, and the latest version was released in 2016, hence, it is termed ISO 13485:2016.

According to ISO, the updating of this standard was done “to respond to the latest quality management system practices, including changes in technology and regulatory requirements.” This standard is used to maintain the quality of medical devices by the manufacturers and by the certification bodies to certify the device manufacturers against this standard.

Requirement of ISO 13485 standard:

The requirements of ISO 13485  certification in Kuwait ensure that the medical devices- both IVD and plan-table- are of optimal quality and meet the expectations of customers consistently. It also ensures that the manufacturers comply with the regulatory requirements of the country.

ISO 13485:2016 provides a framework for establishing and maintaining a quality management system for medical devices in the organization that manufactures medical devices. This standard can be applied to all organizations regardless of their size. It is useful for those organizations that manufacture medical devices as well as for those that supply materials for the devices.

The structure of ISO 13485 is split into eight sections, out of which, the first three are introductory in nature, and the last five contain the requirements for quality management systems for medical devices. Let us briefly overview the specifications of the last five sections:

Section 4: Quality Management System – It deals with the documentation requirements of quality management systems for medical devices- control of records, quality manual, and control of documents.

Section 5: Management Responsibility – This puts an onus on the top management to effective implementation of the QMS for medical devices. The top management is also expected to review the ongoing processes in a timely manner in order to ensure customer satisfaction and continual improvement of the system.

Section 6: Resource Management – It specifies the requirements for the management of all the resources such as human resources, infrastructural resources, work environment, etc.

Section 7: Product Realization – This section deals with all the necessities for planning and creating the products or services, such as review, design, purchasing, and controlling the equipment for monitoring and measurement of the product and processes. The requirements of this section may be excluded for those organizations that are not involved in the creation of products and services.

Section 8: Measurement, Analysis, and Improvement – This includes the requirements for monitoring and measurement of the effectiveness of your QMS. It includes assessing customer satisfaction, internal audits, monitoring products, and processes, dealing with non-conforming products, and corrective and preventive actions.

Which organizations are eligible for ISO 13485 Certifications?

Organizations of all sizes that are involved in the manufacture of medical devices or supply materials for the manufacture of such devices are eligible for ISO 13485 certification in Kuwait. It contains the requirements for organizations operating at all levels for manufacturing
medical devices as well as for those involved in the pharmaceutical supply chain. ISO 13485 certification becomes important for all those organizations that need to demonstrate their compliance with the regulatory requirements, as stated by the government.

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There are numerous procedures that a company needs to follow in order to get ISO 13485 certified.

Before starting your certification journey, you need to implement the quality management system in your organization and operate it for some time to check its effectiveness. When you are sure about your management system, you should apply for ISO 13485 certification.


During the application process, you are required to provide details about your business and certification requirements to the certification body.


The technical team at SIS Certifications will review and verify the specific details provided by you in the request form. The customer is then obliged to accept and sign the certification proposal.


Beginning a certification audit involves two phases:

Stage 1 is a documentation audit and Stage 2 is the Primary Audit.

Phase 1 (DOCUMENTATION AUDIT)– At this stage, the auditor of the certification body verifies the preparedness of the organization for stage 2 audit based on procedures.

Phase 2 (PRIMARY AUDIT)– This verifies the extent of the fulfillment of the standard requirements.


After the non-conformances identified by the ISO auditor, you must implement measures to close them.


When all non-conformances are closed and all findings are documented in the ISO review report, the concerned body, such as SIS Certifications, will provide you with the required ISO certification.


This is an audit that is performed periodically to ensure that your management system continues to meet the requirements between audits.

It must be noted that the International Organization for Standardization (ISO) does not certify, it just publishes the ISO standards. An external body performs the certification. SIS Certifications is one such body that has a reputation for being one of the best in the world. Our vast pool of auditors is recognized for their expertise in comprehensively auditing the compliance of your management systems against the required standards and awarding you with the certifications at the end. The smoothness in the process, our integrity, and our commitment to deadlines make us stand apart from other certification bodies.









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ISO 13485 is a worldwide standard for the implementation of Quality Management Systems for Medical Devices within an organization. It assists organizations in the identification of risks to business continuity and the development of prevention and mitigation strategies.

This makes it possible to monitor your environmental aspects, reduce impacts and ensure compliance with the law. It helps organizations improve their environmental performance by using resources more efficiently and reducing waste, achieving competitive advantage and stakeholder confidence.

The ISO 13485 standard can be applied to any type of organization, irrespective of size or sector. Any organization that intends to develop its long-term operations should implement the requirements of ISO 13485.

The ISO 13485 certification is the latest version of the ISO 13485:2016 Medical Devices Quality Management System that was published on March of 2016.

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