Certification - Medical Devices

ISO 13485


Medical Device Quality Management System

What is ISO 13485?

ISO 13485 Medical Device Quality Management System (MDQMS) is an internationally recognised standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices throughout the world.

ISO 13845 is beneficial for many organisations, which includes organizations that involved in the design, manufacture, wholesale, retail, transportation or maintenance of medical devices. Hence, this standard can be used by suppliers and external parties that are involved with providing medical device product.

The requirements of ISO 13485 are applicable to organisations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, they apply equally to associated services as supplied by the organisation. The requirements may vary based upon the class of medical device.

The processes required by ISO 13485 that are applicable to the organisation, but are not performed by the organisation, are the responsibility of the organisation and are accounted for in the organisation’s quality management system by monitoring, maintaining, and controlling the processes. For instance, an organization who claims to be the manufacturer of a medical device and selling the device under its brand name while outsourcing the manufacturing activity of the medical device to a OEM or a Contract Manufacturer shall be responsible for ensuring the quality of the device and its compliance to applicable legal and standard requirements as well as being accountable for the performance of the device.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organisation to ensure that claims of conformity to ISO 13485 reflect any exclusion of design and development controls. For instance, the Malaysian Medical Device Authority Guidance Document for the Conformity Assessment For Medical Devices (MDA/GD/0031 October 2017 First Edition) specifies that manufacturer of Class A and Class B devices may exclude design and development controls.

  • Benefits of ISO 13485
  • Current version of the ISO 13485

Benefits of ISO 13485

  • Improved risk management and quality assurance
  • Meeting customer expectations and improved ability to respond to customer requirements
  • Increased efficiency and cost savings
  • Improved ability to win more business through proven business credentials
  • Help to maintain the quality of the supply chain

Current version of the ISO 13485

The current version of the Medical Device Quality Management System Is the ISO 13485:2016 which was published on March 2016. The ISO 13485 structure is split into eight sections, because it is aligned with ISO 9001:2008. The first three are introductory, with the last five containing the requirements for the Quality Management System. Here is what the five main sections are about:

Section 4: Quality Management System – This section talks about general QMS requirements, as well as the documentation requirements of the standard. It includes the requirements for the Quality Manual, Control of Documents, and Control of Records, all of which are required documents in the QMS.

Section 5: Management Responsibility – The management responsibility requirements cover the need for top management to be instrumental in the implementation and maintenance of the QMS. Along with planning for the QMS, there is a need for top management to be involved in the ongoing review of the system to ensure customer satisfaction and improvement.

Section 6: Resource Management – The section on management of resources is short, but covers the necessity to control all resources, including human resources, buildings, and infrastructure and the working environment.

Section 7: Product Realization – The product requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service. ISO 9001 allows for requirements in the section to be excluded if they are not applicable to the company (such as a company that does not design products or services).

Section 8: Measurement, Analysis and Improvement – This last section includes the requirements needed to make sure that you can monitor whether your QMS is functioning well. It includes assessing customer satisfaction, internal audits, monitoring products and processes, dealing with non-conforming product, and corrective and preventive actions.

These sections are based on a Plan-Do-Check-Act cycle, which uses these elements to implement change within the processes of the organization in order to drive and maintain improvements within the processes.