Services according to the Quality Management System ISO 13485
Our team of experts have over 25 years of experience and can help you implementing the Quality Management System (QMS) according to ISO 13485.
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Achieving your ISO 13485 Quality Management System
Challenges of obtaining an ISO 13485 Quality Management System
Guidance from start to finish
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Your partner for ISO 13485 Quality Management System (QMS)
What is ISO 13485?
ISO 13485 is an international standard that manufacturers, suppliers and distributors of medical devices can meet to demonstrate their compliance with legal requirements related to medical devices. This standard can also be applied for other companies involved in the chain process of a medical device, such as design and development, storage, treatment, distribution, maintenance, installation, service and cleaning/sterilisation of medical devices. Using ISO 13485 can help to standardise and systemise the medical device development process. Regardless of this, the European Medical Device Regulation does require that a Quality Management System (QMS) is in place, even though it does not identify with ISO 13485 directly. Certification Experts can act as your QMS consulting advisor to determine the applicable Quality Management System for your organisation.
When is an ISO 13485 required?
An ISO 13485 certificate is issued by an independent, impartial and expert certification body. When CE marking medical devices is applied parallel to the ISO 13485 certification, the certification is done by a Notified Body (NoBo), who will then provide an ISO 13485 accreditation. This certification shows that your organisation meets the legal requirements and that you have increased the reliability of your medical device. Once you have obtained the ISO 13485 certification, your company complies with all relevant ISO 13485 clauses.
However, it is important to note that the ISO 13485 certification is not mandatory by regulation, unless a Notified Body (NoBo) is involved. This is the case when a medical device has a risk classification higher than class I. ISO 13485 is a harmonised standard for quality management systems for regulatory purposes. Therefore a Notified Body uses this standard to assess if a manufacturer meets the requirements for a quality management system.
For class I manufacturers it is not mandatory, also for distributors, importers and other parties involved in the chain of the production (not being legal manufacturer).
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Difference between ISO 9001 and ISO 13485
Manufacturers can or must be ISO 13485 certified if their company is involved with medical devices. This is because they will then require more documentation regarding their procedures and registrations. ISO 13485 is the standard that is set specifically for medical devices, which states that a company must guarantee the quality, safety and effectiveness of medical devices. This starts with the manufacturers, where the medical device is designed, developed and produced, and can also be applied to distributors, importers and suppliers in the chain. This applies to all medical devices from class I, IIA, IIB, III. ISO 13485 certification can only be achieved when you are involved in the life cycle of a medical device.
Every company can acquire an ISO 9001 certification. The ISO 9001 standard defines general quality requirements whereas ISO 13485 explicitly addresses the requirements for medical devices and the processes for design, development, production and post-productive activities. The ISO 9001 is more focused on how the company is organised to keep customer satisfaction and continuous improvement central, whilst ISO 13485 validation mostly focuses on the following:
- The safety and efficacy of the medical device and its maintenance
- Post market surveillance (feedback) with regards to the medical devices
- Compliance with laws and regulations regarding medical devices
The Roadmap for ISO 13485 by Certification Experts
Our team of experts use a six step approach to implement the ISO 13485 QMS.
- Gap analysis: The performance of your business unit is assessed to determine whether business requirements or objectives are being met and, if not, what steps should be taken to meet them. Based on the gap analysis, your company has a clear view on how much time is spent, which costs are associated with this and how much effort it will take.
- Management system: Set up and implement a practically manageable, digital management system in accordance with the standard and your needs.
- Internal audit: Testing of the management system against standards, the law and your own requirements. The internal audit is also the preparation for the certification audit.
- Management review: Assessment of the effectiveness of the management system by management or management.
- Guidance and certification: Guidance during the external audit by the certification body. Your company is now certified.
- Maintenance: Periodically update and update the management system, so that your organisation continues to meet the requirements of the standard.
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