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ISO13485 Revision Reaches The Final Stage

Revision development of the International Standard ISO13485 has reached the final stage, with the voting by the Participating (and Observing) members of the FDIS ongoing till the end of this calendar year (2015).

On May 2015, I represented the ISO TC210 Workgroup 1 committee and presented some of the revision highlights in an Asia Pacific Medical Device Forum. They include:

  • application of risk based thinking to QMS processes outside of product realization.
  • evaluations related to changes in regulatory requirements during management reviews
  • assuring that training is effective in achieving competency of personnel to perform their functions
  • requirements related to design transfer and design records
  • design verification and validation of process and medical device software
  • requirements for the protection of confidential health information
  • clarification and additional requirements focused on complaint handling (requirements for documentation of complaint handling procedures, timely handling of complaints, and compliance with regulatory requirements)
  • planning requirements for corrective and preventive actions


The Standard Is For All Medical Device Organisations

One of the key changes and clarifications in the proposed revision is the applicability of organisations:

“This International Standard 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 including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this standard can also be used by suppliers or other external parties providing product (e.g., raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this standard or can be required by contract to conform.


Several jurisdictions have regulatory requirements for the application of quality management systems by organizations with a variety of roles in the supply chain for medical devices. Consequently, this standard expects that the organization:

  • identifies its role(s) under applicable regulatory requirements,
  • identifies the regulatory requirements that apply to its activities under these roles, and
  • incorporates these applicable regulatory requirements within its quality management system.”

The revised Standard added key definitions such as:

  • Authorized Representative
  • Clinical evaluation
  • Complaint
  • Distributor
  • Importer
  • Life-cycle
  • Manufacturer
  • Performance evaluation
  • Post market surveillance
  • Risk
  • Risk management

Shall We Move Ahead With The Revision?



The clarification of the scope and the added definitions enables the Standard to be more effectively utilized by the regulations on the entire value chain within the medical devices industry. This would be valuable for countries seeking to develop or improve on their regulatory framework on quality management systems requirements for importers, distributors, authorised representatives and service providers, in addition to manufacturers and suppliers.   Regulation along the medical device value chain would have a positive impact on ensuring product quality, and therefore product safety and performance.


Or Shall We Remain As Is?

However, this ISO 13485 revision has not adopted the High Level Structure, which may pose challenges for organisations that need to comply with both ISO 9001 (for which the 2015 version complies with the High Level Structure) and ISO 13845. For example, a company that deals with both medical devices and non-medical devices and that has to comply with both ISO 9001 and ISO 13845.


ISO 13485 is mandated to follow the High Level Structure, and the TC 210 Workgroup had acknowledged so. Therefore the Standard will have to go through a systematic review and a subsequent revision to be made to align with the High Level Structure. This new revision of the Standard will mean that organisations and certification bodies would have to implement this next revision, along with the associated costs.

We hope the P and O Members from TC210 understand both sides of the coin, and vote accordingly for the betterment of the medical device industry.


More Guidance for ISO13485 (and ISO9001)

The new work item projects (NWIP) considered at TC 210 level includes guidance that explains the Standard in more detail, and guides the implementation of it in a user-friendly way. Another item considered is a mapping exercise between ISO 13485 and ISO 9001:2015. Both work items aim to improve understanding and compliance to the ISO 13485 Standard, and to fulfil the need to guidance on how to comply with both ISO 13485 and ISO 9001 successfully


About the author:

Ee Bin is a member of the ISO TC210 Workgroup 1 – Application of quality systems in medical devices, participating in the ISO13485’s revision and guidance development, as a representative of the 26 member economies of the Asia Harmonisation Working Party (AHWP).


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