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Certification According to EN ISO 13485

Certification According to EN ISO 13485

Quality Management System EN ISO 13485 certification

Implementing and maintaining a robust quality management system (QMS) for your medical devices, products and services provides an indispensable foundation on which to build your business. EN ISO 13485 certification of your QMS demonstrates your commitment to operating at a global standard.

The EN ISO 13485 qualification process includes on-site audits to verify the capability and reliability of your quality management system. Our experts assess both the practical application and degree of effectiveness in the areas of design, development, production and customer care.

A well-respected and globally recognized Notified Body, we hold extensive accreditations and are able to serve you at regional facilities worldwide. Our one-stop-shop portfolio consists of comprehensive services designed to accommodate your unique circumstances and business needs.

Optimize your QMS to the global standard of excellence!

Benefits of EN ISO 13484 certification

Medical devices (including Class I) greatly benefit by choosing to comply with the international EN ISO 13485 standard. The certification framework provides for more product opportunities and extensive market access approval. Manufacturers and sub-contractors of medical devices can leverage their certified QMS status for a seamless transition into specialized certifications such as TCP, MDR, IVDR, and MDSAP. Start-up businesses benefit from the strong position EN ISO 13485 certification provides for future growth and expansion. Mindful preparation for the audit can also serve as an opportunity for all those in the medical devices industry to further refine QMS processes and workflows.

Four steps to EN ISO 13485 certification:

Four steps to EN ISO 13485 certification | TÜV Rheinland

  1. Optional preliminary audit
    Voluntary site inspection and quality management documentation review assessing your readiness for full-scale Phase I & II auditing.
  2. Audit: Phase I
    Assessment of certification eligibility determined by results of on-site inspection, quality management documentation analysis and business assessment.
  3. Audit: Phase II
    On-site evaluation of quality management system for excellence in areas of applied practice and efficiency.
  4. Certification
    Official confirmation certifying the integrity of your quality management system and complete compliance to the standards.


First-time applicants benefit greatly from opting to undergo the preliminary audit. The process facilitates timely and effective preparation for the official EN ISO 13485 audit process. You are provided documented results that can be immediately applied for making adjustments in your processes prior to commencing with the mandatory audits.
Transfer of Certification applications are also being accepted, in addition to applications for Certification Renewal.

Our services are conducted using the four-eyes principle, which mandates the evaluations by the audit team and product experts be followed by an independent review for final decision.

Choose an experienced partner for your certification

We are a globally operational Notified Body with a wide range of accreditations and certified staff serving an extensive list of customers from every industry. Our EN ISO 13485 experts are here to serve you and your business around the world. Have confidence in your certification options and market access knowledge. Build your ideal certification package from a comprehensive list of services from a single provider.

SNI ISO 13485:2016 Certification

SNI ISO 13485: 2016 specifies requirements for quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customers requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. This international standard defines requirements of quality assurance systems for the design/development, production, customer service and assembly of medial devices.

Our experience as “Notified Body” for medical products LSSMMAK (Lembaga Sertifikasi Sistem Manajemen Mutu Alat Kesehatan) is a guarantee for well-founded monitoring of your quality management system in accordance with ISO 13485:2016.

Who should apply for SNI ISO 13485:2003 ?

SNI ISO 13485:2016 is applicable to organizations providing medical devices, regardless of the type or size of the organization.

SNI ISO 13485:2016 Accreditation Scope

  • Active Medical Devices
    • Electro-medical (non-implantable, non-radiation/thermal therapy)
    • Software
  • Non-active Medical Device (Implants/ Non-implants
    • Plastics
    • Metals
    • Textiles and fibers
    • Sterilized products

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