The ISO 13485:2016 is an internationally recognised standard that sets requirements for a quality management system within the medical device industry. The standard is based on the ISO 9001:2015 with additional requirements for the medical device industry. The standard is in line with EU directives which state that medical devices may only be placed on the market if they bear a marking.
The international standard focuses on the entire chain and covers the entire life cycle of a medical device. This is used to check whether the medical devices meet the requirements of the standard, with an emphasis on risk management. With this standard there are more possibilities for you as an organisation to meet the requirements of legislation and regulations and those of your customer.
The requirements in ISO 13485 are used by suppliers or other external parties providing products or services to medical device manufacturers. By using ISO 13485, organizations will be able to demonstrate compliance with regulatory requirements, manage risk, ensure best practices for quality and safety, improve processes and provide confidence to patients.
What are the main changes?
- Definitions such as the manufacturer, distributor and importer are clarified to clarify who is considered to be the legal manufacturer due to regulations;
- Risk management and decision-making where basic risks not only applies to the design and development, but to all aspects of the quality management. The term risk has been added to the standard requirements in approximately 30 places;
- Additional requirements, and clarity with regard to verification, validation and design activities; including the addition of transfer of the design as a design activity (section 7.3.8) and the synergy with the FDA Device Master Record (DMR) as indicated in section 4.2.3.;
- Reinforcement of supplier control processes;
- Increased focus regarding feedback mechanisms;
- More explicit requirements for software validation for different applications.
ISO 13485 is not aligned with the High Level Structure (HLS) as in the ISO 9001: 2015. The medical device manufacturers that are certified for both ISO 13485 and ISO 9001 will have to be aware of the difference in structure.
The standard focuses on medical devices suppliers and can, where necessary, be combined with other standards such as ISO 9001:2015.
What are the benefits of QMS International?
- QMS International offers the possibility of certification within 45 days;
- It applies a pragmatic and standards-based approach;
- An independent and ethical attitude;
- Qualified auditors for several ISO-standards with excellent knowledge of the industry and standard(s);
- Non-bureaucratic approach towards our customers;
- No unexpected costs and delays;
- Extensive worldwide experience with management systems.