Medical Audits ISO 13485

Validating Your Quality Management System

Certifications build trust – a crucial factor when it comes to medical devices. EN ISO 13485 is the international standard for quality management systems for medical devices. We examine your quality management practices for medical devices, focusing on design and development, production, customer service, and assembly. Benefit from the positive effects of a quality management system: lean processes, efficient work flows, and international recognition.

Benefits at a Glance

EN ISO 13485 certification by the experts at TÜV Rheinland allows you to:

  • Communicate your high standards of quality
  • Gain a competitive edge thanks to independent certification
  • Use our accreditation as a notified body for all your medical devices
  • Benefit from our wealth of international experience in the medical devices market

Our Service to You:

  • EN ISO 13485 certification for your quality management system
  • EN ISO 13485 certification for Health Canada (CMDCAS)
  • EN ISO 13485 certification for the Japanese Ministry of Health (PAL)
  • EN ISO 13485 certification for the Taiwanese Department of Health (TCP)
  • EN ISO 13485 certification for processing of medical devices

Four Steps to Your Certificate

1. Optional Preliminary Audit
Consultation and preliminary assessment during which we inspect your site and review your quality management documentation.

2. Initial Certification Audit: Phase 1
We audit your site to determine whether you are eligible for certification or analyze all the required information on your company. We review your quality management documentation for compliance with EN ISO 13485.

3. Initial Certification Audit: Phase 2
On-site, we examine how your quality management system is applied in practice and evaluate how effective it is.

4. Certificate
If you meet all the criteria, we issue a certificate confirming compliance with standards and the integrity of your quality management system.

Level 2-4-2 Risk management according to EN ISO 14971

ISO 14971 for the application of risk management specifies a process for a manufacturer to identify the hazards associated with medical device, including in vitro diagnostic (IVD) medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The risk management file must have that particular defined and documented Risk management process that addresses risk analysis, evaluation and control, collection of production and post-production data to validate or change previous risk determinations.

Level 2-4-1 Quality Management System according to EN ISO 13485

Introduction to ISO 13485

  • To evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements.
  • ISO 13485 is not a product standard. It’s a process standard.
  • Therefore, it’s not enough to establish a quality management system that complies with the ISO 13485 standard, you also need to comply with all relevant product and service oriented technical standards and regulations

ISO 13485:2003 is based on the ISO 9001:2000 process model.

ISO 13485:2003 was written as a model to meet the quality system requirements of various global regulations.

With the shift in emphasis to be model for regulatory requirements, the writers of ISO 13485:2003 removed the emphasis on customer satisfaction from ISO 9001:2000.

ISO 13485 has not been adopted by the FDA, who will continue to have separate Quality System Regulation (QSR) requirements, however, the FDA participated in writing ISO 13485:2003 to make sure their requirements and ISO 13485:2003 are aligned.

ISO 13485:2003 was not written to be a business improvement model—it was written as a tool for maintaining the effectiveness of processes.

Unlike ISO 9001:2000, ISO 13485:2003 will not allow manufacturers to rationalize documentation. In order to ensure companies meet regulatory requirements, ISO 13485:2003 is more prescriptive, and requires that certain procedures still need to be documented.

Risk management is also a very key element of ISO 13485:2003.

There is no significant relationship between ISO 13485:2003 and ISO 9004:2000—the Quality Management System fundamentals standard.

ISO 13485:2003 is compatible with other “non-quality” management systems such as ISO 14001, or OHSAS 18001

Placing CE marking (CE 0197)

Upon showing compliance to applicable requirements, a Technical Construction File needs to be made along with a Declaration of Conformity.  Based on the declaration the manufacturer or authorized representative can mark the device with CE.

Contents of Technical Construction File

  • Manufacturer Information
  • MDD Agreement ( EU rep)
  • EC Declaration of Conformity
  • Design & manufacturing docs
  • Classification details
  • List of harmonized standards
  • Test reports
  • Operation information
  • Biocompatibility
  • Clinical evaluation
  • Essential Requirements (93/42/EEC MDD Annex 1)
  • At disposal of EU authorities compiled by manufacturer or authorized representative