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The EN ISO 13485:2012 was also superseded by the EN ISO 13485:2016 and similarly, organizations that certified with the EN ISO 13485 will have 3 years to transit to the new EN ISO standard.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