ISO 13485:2016 will replace ISO 13485:2003 and ISO 13485:2012. The revised ISO 13485:2016 was published on 1st March 2016.
The standard is aligned with ISO 9001:2008 and not ISO 9001:2015. This misalignment is due to the revision of both standards being completed in parallel to one another.
The changes were managed by the ISO technical committee 210. Its role was to ensure that this quality management system standard remains fit for purpose given developments over recent years with product specific requirements outlined in device directives such as; the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC and the Medical Devices Directive (MDD) 93/42/EEC.
Clients who currently hold accredited certification against ISO 13485 have until 28th February 2019 to successfully transition to ISO 13485:2016. To find out more on your specific transition requirements click here.
ISO 13485:2016 is a standard that focuses on the importance of the life-cycle of a medical device, including its design, development, production, storage, distribution, installation, servicing and final decommissioning. The standard is designed to assist organizations in focusing their management system and therefore practices on strengthening its risk management approach and meeting regulatory requirements. The following is a major revision of the ISO 13485:2016 standard.
1. Scope of Application
The scope of the standard has been modified in order to emphasize the applicability to organisations that have a role in one or more stages of the products life cycle. It is not just intended for use by the organisation who ultimately place the device on the market as the legal manufacturer.
ISO 13485:2016 clearly describes the applicability to those organisations who, for example, provide services such as storage, distribution design & development, transport sterilization, installation, repair and maintenance, software, hardware and parts.
2. Excluded Clauses
The new standard allows organizations to exclude more clauses from its management system on the grounds of them not being applicable. This includes certain terms within clauses 6, 7 and 8 of ISO 13485:2016. This has been included to allow organizations to implement and maintain a management system that meets their current business model reflecting the applicability of ISO 13485:2016.
3. Effective Terms and Definition
The terms of the new standard have been further revised and expanded to include technical terms such as, clinical evaluation, complaint, authorized representative, life-cycle, manufacturer, risk and risk management.
4. Global Regulatory Compliance
ISO 13485:2016 has also expanded its emphasis on compliance with regulatory requirements. It now includes reference to global regulations such as American FDAQSR820, Japanese JPAL regulations MO169, GMP in Brazil, the European Union regulations MDR and IVDR, Canada, Australia and China's laws and regulatory requirements.
This has made the standard relevant to a wider range of compliance requirements across the globe.
5. Risk Management
The standard now embraces a risk management approach. "Risk" and "risk management" are mentioned many times in ISO 13485:2016, including the risk control of suppliers, the specific risk of the medical device, customer feedback mechanisms, complaint handling and data and trend analysis. Each of these areas are designed to enhance the risk monitoring system and increase the operational efficiency of the organization.
ISO 13485:2016 is currently going through a transition period which ends on 28th February 2019.
Clients that hold accredited certification for ISO 13485:2003 or ISO 13485:2012 should now begin to understand and implement the relevant changes between the two standards to ensure a successful transition by the 28th February 2019.
The new standard places greater emphasis on regulatory requirements, risk, infrastructure, complaints management and design control etc.
Any client’s that have not transitioned by the 28th February 2019 will find their certificates cease to be valid beyond this date and will therefore need to start the initial process again.
HOW WE CAN HELP YOU
We are here to support you throughout the transition process. If you have any questions or need any help we can support you with:
Further Technical Info. Visit our ISO 13485:2016 blog
Specific Technical Advice. Please call us on 0800 052 2424 with any questions you have.
Pre-Assessment / Gap Analysis. We can provide a Pre-Assessment or Gap Analysis of your revised Management System to determine the level of compliance to the requirements of the new standard.
The Standard. Obtain a copy of the standard from ISO here.
If you have any questions or just want to speak to someone regarding your transition please give us a call on 0800 052 2424 or email our dedicated team on firstname.lastname@example.org.