ISO 13485 Quality Management Systems (QMS) for Medical Devices

ISO 13485 is the international quality management system (QMS) standard for medical devices. With patient safety at its heart, it’s intended to ensure manufacturers meet both customer and regulatory requirements.

The standard provides organisations with a framework for implementing the QMS. This includes the establishment – and maintenance – of processes that ensure safety and quality for the entire lifecycle of a product. Product design, development, production, distribution, installation, and servicing must be thoroughly considered and consistent.

ISO 13485 originated on the requirements of ISO 9001 enhancing requirements to cover effective documentation, monitoring, design, and manufacturing controls to produce safe medical devices. ISO 13485 also takes a granular approach in relation to customer feedback, managing non-conforming products and implementing improvements.

The standard was first published in 1996 by the International Organization for Standardization (known as ISO) specifically for the medical device industry, including manufacturers, suppliers, service providers, distributors and importers. Currently, there are over 33,000 valid ISO 13485 certificates that have been issued by accredited certification bodies such as NSF.

ISO 13485 compliance can help organisations reduce risk, create efficiencies, and demonstrate a commitment to safety and quality at every stage of a product’s lifecycle. The QMS standard is recognised by global regulatory authorities, helping organisations to gain access to markets around the world.

Organisations certified to ISO 13485 claim the following benefits:

• Improved product quality.
• Reduced risk of product failure and recall.
• Increased customer confidence.
• Enhanced efficiency and understanding of best practise.
• Ease of access to global markets.

Voluntary ISO 13485 certifications provide confidence to acquire supplier contracts and maintain market credibility. These also serve as a pathway to demonstrate compliance and obtain regulatory approval in many countries. For example, the FDA has incorporated ISO 13485:2016 in its regulation with enforcement starting in 2026.

The latest version of ISO 13485 was published in 2016 (known as ISO 13485:2016). It is made up of five main sections, known as clauses. Before an organisation can be awarded certification, it must be able to demonstrate that it meets every requirement of each clause.

This is achieved thorough documentation and record keeping, including detailed specification of how risk is managed internally and in the external supply chain.

The design, development and intended use of products, as well as the lifecycle of the product must be considered when implementing the QMS.

For an organisation to meet – and maintain – the requirements of the standard, it’s important that resources are allocated. As such, it’s important that top management provides full support and is involved in setting quality policy, goals and objectives.

Becoming certified to ISO 13485 involves several key steps. The first is to buy a copy of the standard. This can be purchased direct from ISO. After that, there are five steps to follow:

Certification is valid for three years. During the three-year certification cycle, surveillance audits will be conducted annually to ensure you remain compliant with the requirements of the standard. In the third and final year of the cycle, a recertification audit will take place. If successful, certification will be granted for another three years, and the accompanying annual audit cycle will recommence.

NSF is an ANSI National Accreditation Board (ANAB) accredited third-party certification body for ISO 13485 and our clients range from large multinationals to those that are smaller and specialised in niche areas. Our mission at NSF is to improve global human and planet health, a goal that aligns strongly with ISO 13485’s intention of ensuring patient safety. This makes us proud to work with companies that deliver life-saving and life-changing medical products to their patients.

We work hard to provide outstanding customer service and take pride in the high scores we receive in our client satisfaction survey.

Some organisations seeking ISO 13485:2016 certification hold other sector-specific quality management certifications as they supply products to other industries that have specific requirements for quality management. These could include IATF 16949 automotive quality management, or the AS 9100 series of quality management standards for aerospace as well as ISO 9001.

Although each of these standards differ based on the sectors they relate to, there are some similarities. If you are looking to consolidate any of these management system standards talk to NSF. We are well placed to support organisations to do this, and it could help streamline your quality management certification process.

Our engaging and interactive training sessions delve into core principles of the ISO 13485:2016 quality management system, including the intent, meaning, and interrelationship of the clauses of the standard.

Learn more about our ISO 13485:2016 - Fundamentals -Medical Devices - QMS - Requirements for Regulatory Purposes course that’s delivered virtually for your convenience and can be booked online.

Contact our team if you are looking to get in-house ISO 13485:2016 medical device QMS training delivered to your team.