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.

Benefits of ISO 13485 Medical Devices Quality Management System

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 it updated. The updated version of ISO 13485 was first released in 2003, and the latest version was released in 2016, hence, it is termed as 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.

What are the requirements of ISO 13485?

The requirements of ISO 13485 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 the organizations regardless of their size. It is useful for those organizations that manufacture medical devices as well as to those who 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 system 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 system for medical devices- control of records, quality manual, and control of documents.
Section 5: Management Responsibility – This puts an onus on the top management for 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, 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 creation of product 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 product, 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. It contains the requirements for organizations operating in all the 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 to the regulatory requirements, as stated by the government.


Before starting your certification journey, you need to implement the quality management system in your organization and operate it for sometime to check its effectiveness. When you are sure about your management system, you should apply for ISO 13485 certification. For that, you need to fill the application form and review the requirements of the certification. If you are confident that the processes of your management system meet the standards specifications, you can proceed for an internal audit. Following are the detailed steps for acquiring ISO 13485 certification:
1. Internal audit: This is done to check your ISMS forms.
2. Management audit: In this stage, your administration checks for the realization of the standard requirements.
3. Corrective activities – At this stage, you are required to close gaps in your ISMS as per the findings of the previous audits. You will be needed to document the steps taken.
The organization ISO 14001 standard process is partitioned into two phases:
4. Stage One (documentation survey) – The auditors from the certification body of your choice will review your documentation for its compliance to the prerequisites of ISO 13485 certification.
5. Stage Two (primary audit) – At this stage, the auditors review your processes for compliances and nonconformities according to the requirements of ISO 13485 as well as your own documentation. This is done by reviewing reports, records, and your company practices.
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 which 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

Get certified with ISO 13485 Standard in Kuwait- One of the most recognized standards for Quality Management Systems. The ISO 13485 certification structures and aligns your business credibility and authority resulting in overall efficiency. We would love to hear from you.
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Be it guidance on understanding the standards or choosing the relevant Standard for your organization, SIS Certifications is ready to help you. We ethically serve the best ISO Standards around the globe. We are here for your service, Get in touch with our team today.
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ISO 13485 Lead auditor training course shall help you to develop the expertise to perform the internal and third party audits in compliance with the Quality management system.
The training helps you to implement ISO 13485 Standard in your organization which is a mandatory part to achieve ISO 13485 Certification.
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ISO 13485 Certification- Quality Management System for Medical Devices is the international standard that facilitates norms for safe manufacturing to distribution of medical devices. The primary objective of the standard is to maintain harmony between the legal requirements and the management system. It is obligatory to accomplish ISO 13485 Standard for companies exporting medical devices to other countries.