How to Comply with the New ISO 13485 2016 Standard?
ISO 13485 2016 (or EN ISO 13485 2016 for Europe) is the latest standard for medical devices. It was published in July 2016, and it has a lot of changes from ISO 13485:2003. ISO 13485 2016 includes new requirements for quality management systems and documentation of medical devices. ISO has released ISO 13485 2016 after an extensive revision process to provide manufacturers with a new, up-to-date tool that will help them improve their management systems to reduce risk and deliver high-quality products. Essentially, it is a comprehensive set of standards that covers the requirements for the design, development, production, and distribution of medical devices in Europe. ISO 13485 2016 was created to ensure safety and efficiency in healthcare. It has been revised from the previous ISO 13485:2003 version. There are many new changes in ISO 13486 2016, but it’s not hard to comply with them!
This post will help you understand these new updates!
What is 2016 ISO 13485?
EN ISO 13485 2016 is the latest quality management system (QMS) for medical devices. This is the European version of the International Standard.
ISO 13485 2016 includes new requirements for quality management systems and documentation of medical devices. The International Standardisation Organisation devised the new internally recognised QMS that all medical device suppliers and manufacturers have to adhere to, demonstrating that:
- They have the competency to supply or manufacture substances for the medical industry
- They can supply or design products according to the regulatory requirements
- They are dedicated to maintaining the safety and quality of the medical devices
- Best practices are being used throughout the design, manufacturing, and testing process
The ISO 13485 2016 standards are regularly reviewed and updated where necessary. Requirements have been added or strengthened in areas such as risk management, design control, documentation requirements (including device history records), corrective actions & preventive action (CAPA) processes, complaint handling process, product evaluation/validation statements etc.
An organisation must comply with ISO 13485 2016 in order to be certified as a medical device manufacturer. Certification is mandatory for manufacturers who supply ISO-certified devices within the European market and voluntary for manufacturers supplying products outside of Europe.
There are many issues that you may encounter when attempting to implement these changes into your organisation, so it’s important to seek help from experts!
Companies or organisations that are accredited to the ISO 13485 2016 standard take part in at least one of the following product lifecycle stages during the manufacturing process:
- Providing instructions and technical support for users
- Supplying replacement parts as required
- Maintenance or servicing of the medical device
- Safe and correct installation of the device
- Proper storage conditions and packaging
- Manufacture or mass production of the device
- Product development and prototyping
- Design or conceptualisation of the medical device
Medical device suppliers and other entities can use 13485 2016 in their operations to show that their protocols and systems can maintain quality at every stage of development. As a result, the end-user can rest assured that the medical device manufacturer or supplier is meeting the ISO 13485 requirements throughout the supply chain.
Please note that the ISO 13485 requirements are applicable to all organisations, irrespective of big or small, as long as they are engaged in any one of the lifecycle stages of the medical device design and manufacturing.
In Which Countries is EN ISO 13485 2016 Applicable?
EN ISO 13485 2016 is applicable throughout the European Union, Australia, Japan, Canada, and many other countries for most medical devices. The standard applies to all 165 members of the ISO (International Standardisation Organisation).
What are the ISO 13485 Requirements?
ISO 13485 requirements for the QMS to manufacture ISO medical devices and services that frequently meet the applicable regulatory requirements, including consumer needs. The new ISO 13485 2016 standard is divided into eight different segments, with the first three being introductory and the remaining ones containing the mandatory requirements. The following are the five primary segments that manufacturers and associated entities should comply with:
Section 4: Quality Management System – In this section, ISO talks about the general quality management system requirements, including the documentation required. It consists of requirements mandatory for Control of Records, Control of Documents, and Quality Manual. All these are mandatory documents in the QMS.
Section 5: Management Responsibility – In this section, the ISO talks about the need for robust management measures that are instrumental in the maintenance and execution of the quality management system. Apart from designing and planning the QMS, there is a need for the quality management involved in the review of the QMS to make sure that improvements and customer satisfaction are guaranteed.
Section 6: Resource Management – In this section, ISO covers the necessity of controlling all resources, such as the working environment, infrastructure, buildings, and even human resources. This is the smallest section that contains the mandatory requirements.
Section 7: Product Realisation – In this section, ISO emphasises the aspects of the creation and planning of the medical product or service. It incorporates requirements on product design, planning, product requirements review, purchasing, controlling the medical device, creating the product or service, and measuring the product or service. ISO allows the requirements in Section 7 to be excluded in case they are not applicable to the organisation, particularly when the organisation is not involved in the design and manufacturing process.
Section 8: Measurement, Analysis, and Improvement – In this section, ISO emphasises the requirements for monitoring and reviewing the quality management system. This ISO 13485 2016 standard involves assessing customer satisfaction, taking corrective and preventive actions, dealing with non-conforming products, and monitoring products and processes.
What’s New in the Updated Version of EN ISO 13485 2016 Standard?
ISO has made some minor changes to the already existing ISO 13485 2016 standard. This time, ISO has given prominence to the increased emphasis on risk. That is, the updated version expects medical device manufacturers and suppliers to apply a risk-based approach for controlling the quality management system processes. This new version applies to an extensive variety of areas, such as:
- Documentation of risk management in product realisation
- Management of CAPA (corrective and preventive actions)
- Monitoring, testing, and traceability of medical devices
- Software validation
- Training of staff and personnel commensurate
- Supplier and outsourcing controls
The new standard of the ISO 13485 2016 will impact the organisation’s objectives and business if not adhered to properly.
If you are interested in the European market you can contact us for a preliminary discussion. You can also look at our dedicated page for ISO 13485.