ISO 13485:2016

What is ISO 13485:2016?

ISO 13485:2016 is an international standard that specifies the requirements for a quality management system that can be applied in the different phases of the life-cycle of a medical device.

What is the purpose of ISO 13485? 

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes is an international standard that specifies the requirements for a quality management system (QMS) targeted to the medical devices industry and that applies throughout the medical device’s lifecycle.

ISO 13485 has been created to be used from initial conception to production and post-production, and includes final decommissioning and disposal. Requirements for storage, distribution, installation and servicing, and the provision of related services are also specified.

Is ISO 13485 a regulation or standard?

Compliance with a regulation is mandatory while compliance with a standard is voluntary. ISO 13485 is a standard and therefore compliance is voluntary. However, since many countries around the world have regulatory requirements for quality management systems that are covered by ISO 13485 in great majority, it is often in your favour to comply with ISO 13485.

Is ISO 13485 mandatory?

Since ISO 13485 is a standard, its use is not mandatory and also the certification of the QMS according to ISO 13485 is not obligatory. However, the establishment of a QMS is required by legislation, and the requirements of ISO 13485 align quite well with most of the regulatory requirements. Therefore, this is the most common method for manufacturers to demonstrate the compliance of their QMS to legislative requirements. The time to set up the QMS is shorter if you follow the standard in comparison to setting up a system from scratch as these are also more prone to errors. The use of harmonized standards (marked EN in EU), or, recognized consensus standards by the FDA in the US, is preferred when trying to prove compliance with the legislation.

Manufacturers should always check the regulatory requirements of the target market and search for a recognized or harmonized standard covering the region. These are published for most legislations.

Currently no harmonized standards exist for the EU Medical Device Regulations (MDR). Until harmonized standards are published, the latest editions of standards should be used, as they are the state of the art and therefore their use to prove compliance with MDR can be justified.

What does it mean to be ISO 13485 certified?

When an organization is “ISO 13485 Certified”, this means that it has implemented a quality management system and has been audited by an accredited independent auditor or certification house who has confirmed that the QMS successfully meets all of the requirements of ISO 13485.

What are the steps to obtain an ISO 13485 certification?

Once the decision has been made to obtain the ISO 13485 certification, the organization needs to understand the ISO 13485 standard well enough to implement a quality management system. After confirming that they are satisfied with how the processes of the QMS are being implemented in practice, the organization can get a third-party organization to audit their QMS against the ISO 13485 standard.

In summary, the steps to obtaining an ISO 13485 certification are:

  1. Planning the Quality Management System

  2. Implementation of the Quality Management System

  3. Certification Audit

  4. Maintenance of the Quality Management System & Certificate

Once the certificate is obtained, an audit is performed every year to highlight any areas that need improvement. Re-certification is done every three years.

What are the benefits of meeting ISO 13485 requirements?

The requirements that make up the ISO 13485 standard is the current internationally-recognized best practice for organizations that manufacture medical devices. By complying with ISO 13485, you are ensuring that your organization has a top-class quality management system for medical devices that encompasses safety and customer satisfaction. Complying with ISO 13485:2016 also means that you have a QMS that is in-line with the constantly changing regulatory environment.

Who needs ISO 13485 certification?

Although the ISO 13485 standard is not mandatory, it is aimed at medical device manufacturers. The standard itself does not require that organizations be certified in order to apply the standard. Many organizations can benefit from implementing the standard without undergoing the certification process. However, being ISO 13485 certified is the easiest way to demonstrate that you have met the requirements of the standard. This applies to regulators and customers alike.

How much does it cost to get an ISO 13485 certification?

The cost of ISO 13485 certification depends on the organizations experience with standards and quality management systems. If you have no experience and you are starting from scratch, then your quality team may need to attend training courses, you may need to bring in expert consultants and you will have to pay for the audit.

Can I get an off-the-shelf QMS that is compliant with ISO 13485?

Unfortunately, you cannot get an off-the-shelf QMS that is compliant with ISO 13485 simply because the QMS needs to be tailored to the role and size of the organization. Smaller companies or startups are often led to believe that they can get an off-the-shelf QMS that is compliant with ISO 13485, because there are numerous tool providers that advertise their tool as a way to be ISO 13485 compliant. While such tools can be of great help in the maintenance of a QMS, you will always need to build the system yourself or, with the help of an expert who can steer you in the right direction.

What are other standards relevant to medical device development?

Another important standard for medical device development is ISO 14971. Learn more about it here.

For more information

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