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Medical Devices - ISO 13485:2016

Overview of ISO 13485

ISO 13485 specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, starting from the design and development to final decommissioning and disposal of medical devices.

The primary objective of ISO 13485 is for organizations to demonstrate its ability to provide medical devices and related services that consistently meet not only the customer but also all applicable regulatory requirements.

“Medical devices — Quality management systems — Requirements for regulatory purposes”, the title of the Standard positions ISO 13485 as the pre-requisite for manufacturers prior to registering with applicable regulatory authorities and placing their medical devices for commercial distribution such as in Canada, the EU and Malaysia. ISO 13485 is also part of the Medical Device Single Audit Program (MDSAP) which already in operation starting 1st January 2017.

Benefits of Implementing ISO 13485

ISO 13485 provides uncountable benefits - both tangible and intangible. A typical organization would enjoy the following:
  • gain customer’s recognition and approval; open doors to the worldwide markets
  • have a systematic approach to control all its processes and proven methods that will help to improve product quality levels
  • greater transparency and consistency in its output
  • and ultimately, a reduction in customer complaints and regulatory non-compliance, as well as retention of customers

ISO 13485:2016 Key Changes

Key changes in this new edition:
  • Additional terms and definitions
  • Applicability of the standard to organizations throughout the medical devices life-cycle (from design & development to the disposal of medical devices), as well as in supply chain and to external parties that provide QMS-related services
  • Risk-based approach, pertaining to safety and performance requirement of the medical devices
  • “Non-application”  now applicable to any requirements in clause 6 and 8 as well
  • Greater emphasis to documentation (i.e Medical Device File, Design and Development File)

Transition Planning Guidance for ISO 13485:2016

All ISO 13485:2003 certified organizations are given 3 years to work towards full transition to ISO 13485:2016 from the date of the publication.

Transition planning
The EN ISO 13485:2012 was also superseded by the EN ISO 13485:2016 and similarly, organizations that certified with the EN ISO 13485 will have 3 years to transit to the new EN ISO standard.

ISO 13485:2016 Training Programmes

  • Decoding & Applying the Malaysia Medical Device Laws
  • Introduction to Risk Management for Medical Devices - ISO 14971
  • ISO 13485 Process Based Internal Auditing
  • Principles of Process Validation
  • Understanding ISO 13485 : 2003 Quality Management System For Medical Devices
  • Understanding Of FDA 21 CFR Part 820 Quality System Regulation
  • Understanding the Requirements for Good Distribution Practice for Medical Devices (GDPMD)
  • ISO 13485:2016 Interpretation
  • ISO 13485:2016 Interpretation and Application
  • ISO 13485:2016 Internal Auditor Training


How different is ISO 13485 from ISO 9001?

As ISO 13485 is developed based on ISO 9001, it is quite similar. A fundamental difference, however, is that ISO 9001 requires the organisation to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate that the quality system is implemented and maintained. Other differences are requirements that are specific to the medical devices industry such as making management responsible for the promotion and awareness of regulatory requirements, controls to ensure product safety, specific requirements for inspection and traceability for implantable devices and specific requirements for documentation and validation of processes for sterile medical devices.

Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The preferred method to prove conformity is the certification of the Quality Management System according ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by a Conformity Assessment Body (CAB). The result of a positive assessment is the authorisation for the CE-identification and the permission to sell the high quality medical device in the European Union.

Is ISO 13485 compatible with Environmental and Occupational Health and Safety Management System standards?
As ISO 13485 is developed based on the ISO 9001:2000 model, it is also compatible with the Environmental and Occupational Health and Safety Management System standards of ISO 14001 and OHSAS 18001 that were similarly based on ISO 9001.

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