ISO 13485 Medical Devices
About ISO 13485 Medical Devices
ISO 13485 is a set of international standards for manufacturers and certifiers of medical devices. ‘ISO 13485 Medical Devices’ means that the medical devices follow all guidelines under ISO 13485 standards. ISO 13485:2016 specifies the requirements for a Quality Management System where an organization needs to demonstrate its ability to provide medical devices that meet the regulatory requirements applicable to the device and, if applicable, patient safety goals.
ISO 13485:2016 Version
The most recent revision of ISO 13485 was published in March 2016. ISO 13485:2016 is a major update from ISO 13485:2003. ISO published ISO 13485:2016 to incorporate changes in regulation and technology, improve clarity, alignment with ISO 9001, and other standards requirements.
What is a Medical Device?
ISO 13485 defines a “medical device” as an instrument, apparatus, appliance, software, material, or other article intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment, or alleviation of disease. Examples of medical devices under the ISO 13485 standard are:
- Spectacle lenses for correcting defective vision
- Pacemakers
- Dialysis machines
- Bone plates and screws for fractures
- Intravenous infusion pumps
What is ISO 13485 Certification?
‘ISO 13485 Medical Devices‘ certification is a process of verifying the conformity of your organization’s medical device to ISO 13485 standards. ISO certification is required by many regulators in response to ISO 13485 Medical Devices Directive. ISO Certification helps you ensure that your medical devices meet high-quality requirements and are safe for customers.
You will need to operate the QMS for a period of time once all of the processes and procedures are in place. You will be able to gather the records you need to move on to the next steps, which include an audit and review of your system, as well as certification. To achieve successful certification, your business should do the following steps after completing all of your documentation and executing it:
- Internal audit – The internal audit is in place to ensure that your QMS procedures are in good working order. The purpose is to guarantee that records are kept in order to certify process compliance and to identify flaws and vulnerabilities that would otherwise go unnoticed.
- Management review – A formal evaluation of the key facts about the management system processes by your management in order to make appropriate decisions and assign resources.
- Corrective actions — After the internal audit and management review, you must address the root cause of any problems that were discovered and document how they were remedied.
There are two stages to the ‘ISO 13485 medical devices’ certification process conducted by a certification body:
- Stage One (preliminary audit): Your chosen certification body’s auditors will verify to see if your documentation complies with ISO 13485 guidelines and conduct a preliminary audit to verify the QMS is properly implemented.
- Stage Two (implementation audit) – The certification body auditors will analyze paperwork, records, and company practices to see if your real actions are compliant with both ISO 13485 and your own documentation. Any non-conformities found in the initial stage 1 audit will be checked to see if they have been resolved. ISO 13485 medical devices certification will be issued once your organization successfully completes the stage 2 audit.
ISO 13485 Training
The ISO 13485 training courses available will provide you with all of the information you need to understand ISO 13485, get started on your ISO QMS, and complete ISO certification audits. ISO 13485 is a complex standard that can be difficult to implement if you don’t know what it’s asking of you. This ISO 13485 training is available to help you learn more about ISO 13485 without having to read through numerous books and study guides.
The ISO 13485 training courses are also beneficial because they provide you with a certification upon successfully completing the course, which shows your employers that you have what it takes to succeed in ISO medical devices quality management system auditing. The following are a list of ISO 13485 training offered:
- ISO 13485 Lead Auditor Course – This is a five-day training course aimed at helping participants comprehend the ISO 13485 QMS standard and how to apply it to auditing management systems against these standards. The course includes an exam at the conclusion to check knowledge and competence, and an individual can only become approved to audit for a certifying organization after completing an accredited course.
- ISO 13485 Internal Auditor Training — This is a two-day course that is based on the lead auditor course above, but it does not go into detail on how to conduct external third-party audits. Therefore, it is best for someone who is just starting out doing internal audits within a company.
- ISO 13485 Awareness and Implementation Courses – These courses give you general information about ISO 13485 and how to put them into practice. These courses can be one or two days long and are important for all employees who implement a QMS within their organizations.
Benefits of ISO 13485 Certification
ISO 13485 certification is beneficial because it shows the world that your organization’s products are produced in accordance with ISO standards, which helps you win more global business opportunities. ISO also has a great reputation for excellence and professionalism when it comes to certifying manufacturing companies all over the world. The following are just some of the benefits of ISO 13485 certification:
- Make new business contacts.
- Obtain a competitive edge
- Increase efficiency while lowering expenses
- Provide medical equipment that is both safer and more efficient.
- Empowered and more knowledgeable employees
- Increase in customer satisfaction, leading to customer retention
Contact IAS today to learn more about ISO 13485 medical devices, or visit our ISO 13485 medical devices frequently asked questions page!
