Medical Device Manufacturers – ISO 13485

ISO 13485 is widely accepted throughout the world as the harmonized international standard that defines quality management system requirements for regulatory purposes within the medical device industry sector.

Medical Device Manufacturers

The rapid development of our competence center for medical devices has continued to grow. With its excellent service, DQS Inc. continues to support customers anywhere in the world. This growth is also a result of increasing international requirements. Therefore, we will support you while entering new worldwide markets for manufacturers of medical devices.

Increasing internationalization is challenging for us and our customers but also a great opportunity. Below are the services that we already offer to our customers worldwide.



ISO 13485:2003

ISO 13485 is the most accepted standard worldwide for manufacturers of medical devices in the United States, Japan, Canada, and the European Union. The standard is based on ISO 9001, but includes additional requirements specific to this business sector. In addition, important terms have been defined including: medical device, active medical device, active implanted medical device, sterile medical device, and many more.

ISO 13485 supports the reduction of unexpected risks with regard to the devices and enhances their management. This applies not only to companies that construct, produce and service medical devices, but also to organizations distributing and using them. The standard aims to increase the organization’s reputation in the eyes of customers and authorities.

ISO 13485

ISO 13485 benefits include:

  • Evidence of adherence to legal and regulatory or contractual requirements
  • Minimize and manage risks
  • Emphasize competence
  • Error prevention instead of error correction
  • Improved performance quality
  • Customer and employee satisfaction
  • Transparency and clarity of internal processes
  • Time and cost savings

ISO 13485 under CMDCAS

DQS Medizinprodukte GmbH, a part of DQS GmbH (the holding company of DQS Inc.,) is one the recognized certification bodies worldwide. Together DQS Medizinprodukte GmbH and DQS Inc. have the ability to issue certificates to ISO 13485 according to the requirements of the Canadian Medical Devices Conformity Assessment System. Since October 2003, DQS Medizinprodukte GmbH has been accredited and listed by the Canadian authorities, Health Canada and SCC, as a CMDCAS recognized registrar.

With a CMDCAS certificate recognized by the Canadian authorities, organizations manufacturing medical devices of the risk classes II, III and IV according to the Canadian MDR (Medical Devices Regulations) can receive approval for the Canadian market.

ISO 13485:2016

ISO 13485:2016 the long anticipated revision of the standard used by medical device manufacturers worldwide has finally been published. The standard is now based on ISO 9001:2008.

DQS Inc. now accredited to the new version of ISO 13485 and able to perform upgrade audits. DQS is also able to offer gap assessment services for organizations.

Gap Assessments to ISO 13485:2016 benefits include:

  • Early identification of missing requirements
  • Early evaluation of the organizations risk based approach
  • Minimize and manage risks for upgrade activities
  • Evaluation of process based approach in your QMS
  • Evaluation of incorporation with ISO 9001:2015

ISO 15378:2011

Pharmaceutical companies need to ensure that their own supplier audits fulfill relevant legal requirements. This is why when selecting a supplier of packaging materials, particular attention needs to be paid to their ability to fulfill current GMP requirements. GMP (Good Manufacturing Practices) has been restated as a legal requirement in order to ensure the health of consumers by reducing risk, including contamination and/or mix-ups, in the pharmaceutical and food industries.

First published in 2006, the process-oriented ISO 15378 standard focuses on this perspective. Based on the internationally accepted ISO 9001 quality standard, it contains all of the GMP requirements relevant to primary packaging material, such as batch tracing, risk management, validation, and controlled environment. ISO 15378 applies to all manufacturers of packaging materials that come into direct contact with the medicinal product, e.g. glass, rubber, aluminum, and plastics.

ISO 15378 benefits:

A certificate to ISO 15378, with its holistic approach to GMP and quality requirements, is recognized throughout the world.

  • Evidence of adherence to legal requirements and contractual obligations
  • Reduction and control of risks
  • Clear statement of the organization’s competence
  • Creates competitive advantages
  • Improves quality capability
  • Saves time and costs

Conformity and value generation 

DQS was the first certification body to become accredited for ISO 15378 by the German Association for Accreditation (TGA) in July of 2007. With an independent and expert assessment of their management system, top management can be sure that the system is in conformance with the requirements of the standard. In addition, the auditors will focus on the identification of improvement potential. Finally, audits also result in an increased awareness of whether or not the management system is suitable for achieving the desired results. With value-generating audits, the ideal certification body will provide direction for decision making processes.

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