System Certifications

ISO 13485 – Quality Management System

Demonstrate your commitment to providing safe and reliable medical devices and related services while consistently meeting customer expectations and applicable regulatory requirements.

What is ISO 13485:2016?

ISO 13485 is the internationally recognized standard for Quality Management Systems (QMS) specifically designed for organizations in the medical device sector.

It focuses on ensuring consistent quality and patient safety throughout the lifecycle of medical devices, including design and development, manufacturing, distribution, installation, servicing, and where applicable, disposal.

The standard specifies requirements for organizations to establish, implement, and maintain a QMS that demonstrates their ability to consistently provide safe and effective medical devices and related services while meeting both customer expectations and applicable regulatory requirements.

Although ISO 13485 is based on the process-oriented approach and Plan-Do-Check-Act (PDCA) principles of ISO 9001:2015, it is specifically tailored to the medical device sector. As a stand-alone standard, it incorporates additional regulatory and risk management requirements unique to the industry and therefore cannot be substituted with ISO 9001:2015.

ISO 13485 is applicable to organizations involved in the design, development, production, installation, servicing, distribution, and supply of medical devices, as well as providers of related services and components.

Benefits of certification

  • Supports the stability and consistency of production processes, helping organizations deliver high-quality products and services.

  • Help organizations meet applicable regulatory requirements.

  • Facilitates conformity assessment and compliance with applicable regulatory requirements and directives.

  • Provides independent third-party assessment of the effectiveness and conformity of the established Quality Management System.

  • Helps optimize costs by reducing operating costs and costs associated with nonconforming products, while improving the efficient use of raw materials, energy, and other resources.

  • Enhancing the trust of the public and regulatory authorities in the medical device manufacturer.

Certification process

The certification process consists of three basic phases:

Development of Documentation

Development of the quality management system documentation.

Implementation of the QMS

Implementation and operation of the quality management system within the organization.

Certification by an accredited Certification Body

Assessment and certification of the Quality Management System by an accredited certification body.

The time required to develop the documentation and implement the system varies depending on the size, complexity, and activities of the organization.

Certification by the accredited certification body

  • Registration of the application

  • Agreement for conducting a certification audit (Note: the certification audit is conducted in two stages)

  • Appointment of an audit team

  • Preparation of an audit plan

  • Audit-verification of facts in the following stages:

    • Examination of the client’s documentation
    • Verification of processes and activities on-site
    • Preparation of the Certification Audit Report

  • Assessment of the Audit Report by the Certification Body

  • Issuance of the Certificate

Surveillance & Certificate Validity

The certificate is generally valid for a three-year certification cycle. During this period, surveillance audits are conducted annually to verify the continued effectiveness and compliance of the Quality Management System.

Decision on Confirmation of Certificate Validity

Confirmation that the certificate remains valid until the next surveillance audit.

Decision on suspension

Suspension of the certificate in accordance with the applicable certification requirements.

Decision on Withdrawal

Withdrawal of the certificate in cases of fundamental or significant deviations from the requirements of the applicable standard.

Request ISO 13485 Certification support

Our experts are ready to support your certification journey.