ISO 13485:2016

What are the changes between ISO 13485:2003 and 13485:2016?

The revised standard now covers the Entire Lifecycle and is explicitly applicable for Outsourced Processes. The Regulatory Requirements are no longer limited to the product design phase, but the complete scope of the QMS.
The concept of a „Medical Device Family“ was introduced. Software-Validation was now clearly addressed. Some requirements, e.g. for Design Transfer and for Sterile- Barrier-Systems were included or extended, like for the „Medical Device File“.
Risk Management now covers a company-wide approach. Further on the standard demands to document the Rolls and Function(s) of the organisation. More specific input and output aspects of Management Reviews were added, same as additional documentation requirements for the Work Environment, Contamination Control of sterile medical devices and labelling. The level of focus on Reporting Procedures was emphasized.

EN ISO 13485 – potential customers?

The standard is dedicated to Medical Device Manufac­turers demanded to meet both customer expectations and International, European or National regulatory requirements. Examples are Canadian, US-American or Japanese requirements as well as the European Directives and Regulations on Medical Devices and In-Vitro-Diagnostics. An ISO 13485 Certificate gives objective evidence for an organisation, that the Management- System is compliant with the Standard.

Beside of Medical Device Manufacturers, ISO 13485:2016 can be applied from Suppliers or external Parties, providing goods or services for organisations producing Medical Devices.

DQS Medizinprodukte GmbH is accredited both from the German Accreditation Body (DAkkS) as well as from Standards Council of Canada (SCC) for ISO 13485:2016.

An ISO 13485 certified company

  • gives evidence for regulatory compliance
  • minimises and controls risks
  • contributes to safety of patients and users  
  • underlines the competency of the organisation
  • pursues failure prevention rather than correction
  • improves quality of services
  • improves satisfaction of customer and employees  
  • gives transparency and clarity of internal processes
  • reduces time and effort

Process Flow of QMS Certification

Comparison of ISO 13485:2016 with ISO 9001:2015

The High Level Structure, as known from the revised ISO 9001:2015 standard, was not adopted from ISO 13485:2016. Medical Device Manufacturers, striving for both ISO 13485 and ISO 9001:2015 certification have to be aware about the structural differences. On the other hand it is an advantage, that the new ISO 13485 kept the established structure.