ISO 13485

ISO 13485

ISO 13485:2016

Accredited medical device management system certification

What is ISO 13485?

Medical device – Quality management system – Requirements for regulatory purpose – ISO 13485:2016

It is a internationally recognized standard based on ISO 9000 standard series which is intended to be use by manufacturers, suppliers and other organizations in one or more stages of medical devices life-cycle and production chain.

In order to cover unique specification of medical device manufacturing as an industry sector which is thoroughly regulated and supervised, the ISO 13485 standard has been divided from the ISO 9001 in order to set specific medical device management system requirements on well known process based approach principles Plan, Do, Check and Act.

The quality management standard ISO 13485:2016 was published to support medical device manufacturers, designers, suppliers and other interested organization in building, designing and implementing quality management systems in order to ensure sustainable effectiveness of their processes.

Well established and by bqs. supervised quality management system is right way how to ensure the consistence of design, production, delivery, installation through to disposal of medical devices and in vitro medical devices that are safe and meet performance claims for their intended purpose.

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ISO 13485 certification and CE marking?

As the number one worldwide accepted quality management standard in the field of medical devices, ISO 13485 certification makes a basis for CE marking or even other national certification schemes and supporting regulations around the world. Due to its great integration and ability to demonstrate sustainable improvements and compliance with applicable regulations, it has been recognized as harmonized standard EN ISO 13485 with European parliament and council directives 93/42/EEC, 98/79/EC and 90/385/EEC.

Meeting the requirements of the ISO 13485:2016 and achievement of ISO 13485 certification is the foundation for maintaining regulatory compliance and provide presumption of conformity with the essential requirements of the directives related to quality management system of manufacture which seeks for CE marking and EC certification according to applicable conformity assessment route.

Choose bqs. as your certification body for ISO 13485 certification

  • Accredited certification service
  • Pool of qualified QMS auditors and technical experts
  • Years of experience in executionof QMS audits, CE marking assessments and product testing
  • Professional independent approach to each client ensuring credibility and sustainability of bqs. certification body
  • Objective feedback on the effectiveness of the quality management system
  • Confidence in compliance with applicable European regulations
  • Weak areas early identification, detection of noncompliance and areas requiring attention
  • Confirmation that best practice is achieved
  • Detection of areas of non-compliance and possible risk
  • Reporting and certification that is valuable and recognized

ISO 13485 certification benefits

  • ISO 13485 certification opens new markets, business opportunities and improve market accessibility as a worldwide recognized quality management system standard
  • Ensures position within supplier list of your customers and maintain competitive advantage
  • Demonstrates ability of your quality management system to meet requirements of European medical device directives
  • Reduces production costs by regulate third party auditing and identification of weak points in your management system
  • Enhances reputation and credibility of company by accredited ISO 13485 certification in order to be trusted company

How to achieve certificaiton according to ISO 13485?

ISO 13485 certification consists of several steps prior we are able to grant you certificate as a result of compliance with all applicable requirements of ISO 13485:2016 standard or other relevant regulations.

The steps to ISO 13485 certification


  • Pre audit and gap analysis. Voluntary activity performed prior the formal assessment activities. We will challenge your implemented quality management system against the all applicable requirements set by ISO 13485:2016 standard, in order to have a closer look over your system, facilities and processes, identify and determine all possible gaps in compliance and analyze potential risks and opportunities for improvement. Based on the status of organization`s readiness to comply with ISO 13485:2016,  the assessment activities will be planned.
  • Off-site assessment. Before we take a on-site visit related to conformity assessment, our auditors will review your quality management documentation, procedures and controls over processes you have implemented. All in order to get familiar with specific aspects of your production and found strong and weak points in management system documentation.
  • Stage one audit and stage two audits. Audit teams will challenge your quality management system, process controls, staff  and other resources and determined their compliance with applicable ISO 13485:2016 requirements. All findings identified during the stages will be communicated with your organization and subsequent actions verified.
  • Certification body decision. On the basis of audit team recommendation certification body will take a decision related to issuance of certification. In the case you prove an ability to meet requirements of ISO 13485:2016 quality management systems standards, a certificate with three year validity will be granted to your organization
  • Post certification activities. In order to prove continuous compliance with ISO 13485:2016, bqs. as your certification body will annually perform surveillance audits over your facilities and quality management system in order to verify your commitment to continuous improvement and compliance with applicable requirements.

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