ISO 13485:2016

The ISO 13485:2016 Medical Devices Quality Management System is the quality management standard applied throughout the entire life cycle of medical devices, from design to production and servicing. CMB Consultancy offers certification services through accredited certification bodies to organisations that want to obtain ISO 13485.

What Is ISO 13485?

The EN ISO 13485 Medical Devices Quality Management System standard is the most reliable way for medical device manufacturers and suppliers to bring their products to market with quality and speed. It is also a reference standard used by competent authorities and notified bodies when auditing medical device manufacturers.

The revised version of ISO 13485 was published in February 2016. The ISO 13485 standard defines the requirements showing whether the products of medical device organisations meet the necessary criteria. It ensures that the design, development, production, installation and delivery of medical devices are carried out with safety in mind at all times. It also supports medical device manufacturers in establishing and maintaining effectiveness across all business processes when setting up a quality management system.

ISO 13485:2016 applies to the whole supply chain and covers the entire product life cycle of medical devices.

The three-year transition period between February 2016 and February 2019 has been completed; since then, ISO 13485:2003 and the related European standard EN ISO 13485:2012 certificates are no longer valid.

What Are the Main Changes in ISO 13485:2016?

The key changes introduced by the 2016 version are:

• alignment of regulatory requirements,
• inclusion of risk management in quality management systems,
• more clarity on validation, verification and design,
• strengthened supplier control processes,
• increased focus on feedback mechanisms,
• validation of software used in the quality management system, in production and in medical devices.

Main clauses that were changed:

• Clause 4. Quality management system
• Clause 4.1. General requirements
• Clause 4.2. Documentation requirements
• Clause 5. Management responsibility
• Clause 6. Resource management
• Clause 6.2. Human resources
• Clause 6.3. Infrastructure
• Clause 6.4. Work environment
• Clause 7. Product realisation
• Clause 7.1. Planning of product realisation
• Clause 7.2. Customer-related processes
• Clause 7.3. Design and development
• Clause 7.4. Purchasing
• Clause 7.5. Production and service provision
• Clause 8. Measurement, analysis and improvement
• Clause 8.2. Monitoring and measurement
• Clause 8.3. Control of nonconforming product
• Clause 8.4. Analysis of data
• Clause 8.5. Improvement

Who Is ISO 13485 For?

As a standard defining the specific requirements that quality systems must meet in organisations trading and manufacturing medical devices, ISO 13485 can be applied by all organisations involved in the design, production, installation and supply of medical devices or related services.

In summary, ISO 13485:

• makes it possible, together with CE marking work, for products to demonstrate their health, safety and security characteristics and meet the minimum requirements,
• is a common language with the European Union and other countries in the production, sale and servicing of medical devices,
• is closely related to the CE marking of medical devices,
• is a very important guide for sterilisation and hygiene,
• contains specific requirements for sterile medical devices,
• is a guide for determining the risk classes of medical devices.

The ISO 13485 Quality Management System standard for medical devices can be applied by all institutions and organisations working in the production and servicing of products within the scope of medical devices. For general quality management, see also our ISO 9001 Quality Management System page.