Principle of certification according to EN ISO 13485

Due to the higher demands on the quality management system of the supplier and the manufacturer of medical devices, the EN ISO 13485: 2016 standard was prepared. The standard contains criteria for the full range of quality management systems for medical devices. The certificate, issued by an independent accredited certification body, guarantees that the quality management system at the supplier and manufacturer of medical devices is implemented, documented and used in accordance with the requirements of EN ISO 13485:2016

Quality System Certification for Medical Device Manufacturers Based on EN ISO 13485: 2016 This standard has been published as a harmonized standard for European Directives Medical Device Regulation (EU) 2017/745,  93/42 / EEC, 90/385 / EEC and 98/79 / EC in Official Journal of European Union, which allows its use to demonstrate compliance with the requirements of these European Directives.  This holds true for recently enacted:

  1. EU Medical Device Regulation (EU) 2017/745 – covering inactive, non-implantable medical devices and Active implantable Medical Devices
  2. In-Vitro Diagnostic Medical Devices Regulation (EU) 2017/746
  3. ICMED 13485 – Indian Certification For Medical Devices
  4. ICMED 13485 Plus- (Product Specification as per MoHFW’s Technical Specifications)
  5. MDSAP- Medical Devices Single Audit Program

Crucial elements of the standard

  • Focus on risk-based approach and PDCA approach that help identify opportunities in a structured manner.

  • Regulatory Compliance

  • Places greater emphasis on safety of medical devices

  • Based on the idea of maintaining effectiveness of quality management system for medical devices

  • Emphasis on clinical performance and efficacy of medical devices

  • Regular monitoring of medical device performance through post production and post market surveillance and vigilance

  • Critically managing and maintaining the work environment

  • Effectively addresses supply chain management

Benefits of Certification

  • Guaranteeing the stability of the production process and thus the stable and high quality of provided services and products to customers

  • facilitating the process of demonstrating compliance with the requirements of EU Directives and corresponding government regulations

  • Demonstration of effectiveness and efficiency of the built quality management system by third independent party

  • cost optimization – reducing operating costs, reducing the cost of nonconforming products, saving raw materials, energy and other resources

  • increasing the confidence of the public and state control authorities in the manufacture of medical devices

Certification Process

The certification process consists of 3 basic phases:

1) Elaboration of QMS documentation
2) Implementation of System Documentation
3) Certification by an accredited certification body
The times of elaboration of documentation and putting the system into practice depends upon the client organization.

The certification audit takes places in two stages.

1st stage audit

  • Registration of application for certification
  • Agreement for conducting a 1st stage audit
  • Appointing a team of auditors
  • Assessment of System documentation
  • Preparing an audit plan
  • On-site audit in connection with examination of documentation
  • Elaboration of the 1st stage audit report documenting nonconformities and audit findings

2nd stage audit

  • Agreement for conducting a 2nd stage audit
  • Appointing a team of auditors
  • Assessment of System documentation
  • Preparing an audit plan
  • On-site audit from the point of view of the quality and business process aspects
  • Elaboration of the 2nd stage audit report
  • Assessment of the audit reports by the expert reviwers
  • Issuing the certificate

During the three year validity period of the certificate, a surveillance audit takes place once a year, whose aim is to make sure that the environmental management system is maintained and further developed.

Frequency or period of validity of the ISO 13485 certificate

The ISO 13485 certificate is valid for 3 years. There will be two surveillance audits carried out at a frequency of once per year.

Recertification audit

In order to ensure the continuous validity of the certification, a recertification audit should be carried out in the third year before the certificate expires


  • Certification of quality management systems (ISO 9001)
  • Certification of environment management systems (ISO 14001)
  • Certification of critical control points system in food processing industry (HACCP)
  • Certification of food safety management system (ISO 22000)
  • Certification of occupational health and safety management system (OHSAS 45001)
  • ISO 22716
  • SA 8000
  • IATF 16949
  • Assessment of conformity of products to the requirements of European directives (CE marking of products)
  • Testing of products