ISO 13485
ISO 13485 -What do I need to know?
ISO 13485:2016 is the Standard which specifies the requirements for a quality management system (QMS) for Medical Device companies. Many manufacturers are unaware of the different regulatory and quality requirements necessary for the sale of their medical devices in different markets.
Before we move on to understand more about ISO 13485:2016, let's find out what ISO is?
ISO (the International Organisation for Standardisation) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organisations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardisation.
Several ISO resources can be found on their Online Browsing Platform
Safety and quality are non-negotiable in the medical devices industry; that's where a quality management system helps manufacturers with the correct practices. Do you know if you need a full ISO 13485:2016 Quality Management System or perhaps you require a simplified version? Connect with one of our RAQA Adviser’s for a FREE 30 Minute One-2-One session and learn more about Quality Management Systems. BOOK NOW
Regulatory requirements are increasingly stringent throughout every step of a product's life cycle, including service and delivery. Increasingly, organisations in the industry are expected to demonstrate their quality management processes and ensure best practices in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.
ISO 13485 is designed to be used by organisations involved in the:
- design,
- production,
- installation, and
- servicing of medical devices and related services.
It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
ISO 13485:2016 is a stand-alone QMS standard derived from the internationally recognised and accepted ISO 9000 quality management standard series. ISO 13485:2016 adapts the previous version of ISO 9001, ISO 9000:2008 process-based model for a regulated medical device manufacturing environment. While ISO 13485:2016 is based on the ISO 9001 process model concepts of ‘Plan, Do, Check, Act’, it is designed for regulatory compliance; therefore, it is more prescriptive and requires a more thoroughly documented QMS.
ISO 13485:2016 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures the consistent design, development, production, installation and delivery through to the disposal of medical devices that are safe for their intended purpose.
Read more about ISO 13485:2016 by clicking here.
Would you like to know what happens during a formal ISO 13485:2016 Audit to help you prepare?
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