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What is ISO 13485 certification and how to achieve it?

 

Most global medical device market regulators require manufacturers to implement a quality management system (QMS) as part of their product registration effort. In most countries, ISO 13485 certification is the preferred or required method of meeting QMS requirements.

 

What is ISO 13485?

This international standard is based off the ISO 9001 international standard with specific requirements to meet regulatory needs. This standard, applicable on a voluntary base, was designed in particular for medical device manufacturers; ISO 13485 addresses most or all of the quality system requirements in markets including Europe, Australia, Japan and Canada. The US Food and Drug Administration does not formally recognize ISO 13485 certification, but US Good Manufacturing Practices quality system requirements overlap with the standard in many areas. ISO 13485 is also the basis for quality system regulations in other markets such as South Korea and Brazil.

The ISO 13485 standard, officially named EN ISO 13485:2003, can be used by organizations in the design, development and production process for medical devices but also related services. It can also be used by notification bodies to meet regulatory requirements.

Though replicating the format of ISO 9001, ISO 13485 switches the focus from customer satisfaction and continual improvement to standardization of regulatory requirements for medical devices manufacturers. ISO 13485 can be achieved by upgrading from ISO 9001 or as a standalone certification. Learn more about upgrading to ISO 13485 from 9001 .

   
 

ISO 13485 Certification

In Europe, ISO 13485 (or EN ISO 13485) is seen as the de facto standard for the medical device industry. Based on the broader ISO 9001 standard, ISO 13485 was first implemented in Europe in 1996. Although ISO 13485 certification is voluntary, obtaining certification allows you to meet the quality system requirements of the European Medical Device Directive (93/42/EEC), In Vitro Medical Device Directive (98/79/EC) and Active Implantable Medical Device Directive (90/835/EEC) with less difficulty.

However, it is important to note that while ISO 13485 is an international standard, certification in Europe, for example, does not mean your ISO 13485 certification is valid in other markets such as Canada or Japan. Many countries impose their own additional QMS requirements on top of those outlined in the standard. You must meet those additional requirements – on top of ISO 13485 – to be certified to sell in those markets.

   
 

ISO 13485 requirements

In order to achieve ISO 13485 certification, you must develop written policies for the following functions:

  • Document and record controls
  • Internal auditing procedures
  • Controls for non-conformance
  • Corrective and preventative actions
  • Process and design controls
  • Record retention
  • Accountability and traceability

As you implement ISO 13485, it is important to bear in mind that ISO standards are updated periodically — revisions and updates do occur and ISO 13485 is due for an update in the next few years. As quality system standards are updated, you must ensure that your own QMS keeps up with those updates in order to remain in compliance.

ISO 13485 benefits

Here is what medical device manufacturers can hope to gain from having an ISO 13485 certification:

  • Faster and easier market access to countries that recognize the certification: Canada, Japan, South Korea, Brazil, Australia & New Zealand.
  • Reduce operational costs by highlighting process deficiencies and improving efficiency
  • Increase customer satisfaction by consistently delivering quality products and systematically addressing complaints
  • Proven commitment to quality through an internationally recognized standard
  • Adds transparency to the way complaints, surveillance or product recalls are handled
Please contact us for more information on how to achieve ISO 13485 certification.
 

 

 

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ISO 9001:2008
Quality Management Systems
ISO 14001:2004
Environmental Management Systems
ISO 22000:2005
Food Safety Management Systems
ISO 27000:2009
Information Security Management
ISO 13485:2003
Medical Devices Standard
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