ISO 13485 audit, certification, maintenance

How to certify ISO 13485 Quality Management System for Medical Devices

Where can I find the official name of the standard ISO 13485 and the valid version of the standard?

You can always find the current edition of the standard, amendments or corrections to the standard on the website of the Lithuanian Department of Standardization.

ISO 13485 Medical devices, quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Briefly about ISO 13485

The international standard ISO 13485 is intended to facilitate the global harmonization of the requirements of the relevant legislation implementing the law for quality management systems applicable to organizations that are involved in one or more stages of the life cycle of a medical device. This International Standard includes specific requirements for organizations involved in the life cycle of a medical device. In Europe, ISO 13485:2016 is harmonized with the European Medical Regulation. In this way, the ISO 13485 certificate becomes particularly important for obtaining the right to label medical products with the CE mark. The quality management system requirements specified in this International Standard complement the product technical requirements that are necessary to meet customer and applicable regulatory requirements for safety and performance. The adoption of a quality management system is a strategic decision of the organization.

Objective of ISO 13485

The main objective of the management system according to ISO 13485 is for organizations involved in any life cycle of a medical device to harmonize regulatory requirements according to the Quality Management System standard.

ISO 13485 value

Benefits of ISO 13485 Medical Device Quality Management System:

systematic planning, execution, control, improvement of the organization's operational processes is taking place;
controlled quality of products, processes and services;
resources are used more efficiently;
clearly defined responsibilities and powers;
continuous assessment of risks and their management;
In Europe, EN ISO 13485:2016 is harmonized with the European Medical Regulation. In this way, the ISO 13485 certificate becomes particularly important for obtaining the right to label medical products with the CE mark.

Advantages of a certified management system according to the ISO 13485 standard:

confidence in the manufacturer or service provider is increased;
the reputation and image of the organization improves;
compliance with legal requirements;
competitive advantage when offering or supplying products to the European Union or other countries and participating in public tenders.

Integrated management system

Although ISO 13485 is a stand-alone standard, it is based on ISO 9001:2008, which was replaced by ISO 9001:2015. This international standard allows an organization to harmonize or combine its quality management system with the requirements of related management systems, such as environmental protection or quality management system.

You can learn more about the ISO 13485 standard here: www.iso.org.

More about UAB "Sertika" management system certification process is presented in the document "Management system certification (conformity assessment) regulations" (here) and section „FAQ“ (here).

Do you have questions about management system certification?

We kindly invite you to contact us using the following contacts:

phone: +37060005550;
e-mail/remote chat: vs@sertika.lt;
We can come to you;
address: Mituvos str. 2-255.

In order for us to submit a proposal for certification, the initial information required for the application is:

What certification standard do you want?
Have you installed a system of the desired standard? If not, when do you plan to do it?
What services or product production do you want to certify?
How many people work in your company?
Do you have departments and where are they located?
Where is your office located?
How long and when do you want SERTIKA audit and compliance assessment results?

Feel free to apply now:

Management systems certification and training

Irma Kulpavičienė
+370 (600) 05550
vs@sertika.lt

Specialist

Your question is waiting Head of the Management Systems Certification Department

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