ISO 13485 audit, certification, maintenance
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
ISO 13485 value
- 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
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: email@example.com;
- 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?