Where can I find the official name of the LST EN ISO 13485 standard and the current version of the standard?

• You can always find the current version of the standard, amendments or corrections to the standard on the website of the Lithuanian Standardization Department.
• ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016).

Overview of the LST EN ISO 13485 standard:

This is an international standard for a quality management system (QMS) for medical devices, intended for organizations that design, manufacture, distribute or service medical devices. This standard ensures that organizations comply with the stringent quality, safety and regulatory requirements required in the medical industry.

LST EN ISO 13485 certification process

• Implementation of a quality management system – process analysis and adaptation according to ISO 13485 requirements.
• Internal audit – an assessment of an organization’s performance prior to certification.
• Certification audit – an inspection carried out by an independent certification body.
• Issuance of a certificate – if all requirements are met, a certificate is issued.
• Surveillance audits – periodic assessments to maintain compliance with the standard.

Benefits of LST EN ISO 13485 certification

• Ensures compliance with international medical sector regulations.
• Reduces risks related to the quality and safety of medical devices.
• Improves the company’s reputation and trust in the market.
• Ensures traceability and efficient document management.
• Facilitates access to new markets and international partners.