Everything you need to know about ISO 13485:2016, Quality management of medical devices

Safety and quality are two non-negotiables in the medical device industry.

Regulations are becoming increasingly stringent throughout the life cycle of a product, including on service and delivery. Increasingly, organisations in the industry are expected to demonstrate impeccable quality management processes and ensure best practice throughout the medical device manufacturing chain.

A medical device may be any instrument, apparatus or other similar or related product intended for use in the diagnosis, prevention and treatment of disease or other medical conditions.

Today, there are about 2 million different types of medical devices on the world market, classified into more than 7,000 generic device groups. These volumes also translate into a huge amount of standardisation work.

All ISO standards are reviewed every five years to determine whether a change is needed to maintain market-relevant requirements and information.

The ISO 13485:2016 standard – Quality management of medical devices is designed to address the latest quality management system practices, including changes in technology and regulatory requirements. The standard places significant emphasis on risk management and risk-based decision making, as well as changes related to increased regulatory requirements for healthcare organizations.

What is ISO 13485:2016 – quality management of medical devices?

ISO 13485:2016 – Quality management of medical devices defines the requirements of a quality management system in which organizations must demonstrate the ability to provide medical devices and related services that consistently meet customer needs and applicable regulations. Such organisations may be involved in one or more stages of the lifecycle, including design and development, manufacturing, storage and distribution, installation or repair of a medical device, and design and development or provision of associated activities (e.g. technical support).

At the same time, ISO 13485:2016 – Quality management of medical devices can be used by suppliers or external parties providing products, including services related to the quality management system to such organizations.

Your organisation is certified ISO 9001:2015 – quality management.
What else does ISO 13485:2016 – quality management of medical devices – have?

ISO 13485:2016 – quality management of medical devices is a stand-alone document, with the caveat that it is directly linked to ISO 9001:2015 – the global quality management standard.
Although both standards are in the same QMS (Quality Management System) family, the ISO 9001:2015 standard presents a general set of requirements that require a greater focus on continuous improvement and customer satisfaction. On the other hand, ISO 13485:2016 is oriented towards meeting indicators that specifically address quality performance, with a focus on developing requirements for documented procedures and risk management, in medical devices.

What criteria does your organization need to meet to achieve ISO 13485:2016 certification – medical device quality management?

ISO 13485:2016 – Quality management of medical devices applies to all companies in the medical industry (design, development, production, storage, distribution, installation or repair of a medical device), regardless of their size and complexity.

However, organizations seeking ISO 13485:2016 certification must meet stringent requirements, as it is a necessary step for the organization to fully understand the manufacturing processes of high-quality medical devices.
In the first instance, the organisation is audited by the certification body.
If the organisation meets the requirements of the audit, it receives ISO 13485:2016 certification for three years. After the initial three-year period, recertification follows.

Your organization is certified ISO 13485:2016 – medical device quality management, what are the benefits?

  • risk minimisation and control
  • more efficient and transparent internal processes
  • meeting the requirements of customers as well as other stakeholders (employees, suppliers, investors)
  • gaining a competitive advantage
  • reducing costs

Further details on other standards here.