Medical Devices Industry QMS

ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes has been released on July 15, 2003 and provides a quality management systems model for medical device manufacturers to meet regulatory requirements.  ISO 13485:2003 includes a process model similar to that of ISO 9001:2000 but requires additional documented procedures that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

ISO 9001 is a quality system standard applicable to many industries. ISO 13485/13488 are standards specific to medical device quality systems that supplement the ISO 9001 standard. Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry.

The certification of a quality management system, specifically for medical devices, to ISO 13485:2003 proves advantageous, and in many cases essential, for medical companies which export their products to the global market.

When manufacturers are active in the world market, the focus on global or international standards (e.g., ISO) is not only advantageous - it may be stipulated by certain countries. For example, Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 after January 2003. Existing licence holders have until November 2003 to demonstrate compliance. In the United States, the Food and Drug Administration (FDA) does not intend to change the Quality System Regulation (QSR) in Title 21 Code of Federal Regulations Part 820. US medical device manufacturers with international sales will need to maintain quality system compliance to both the FDA QSR and ISO 13485:1996 quality system standards.  These companies will have three years to transition to the ISO 13485:2003 quality system standard.

 

Who should certified to these standards?

• Medical component manufacturers.
• Companies who currently manufacture private label medical devices, but want to eventually place these devices under their name on the market in the European Union.
• Consultants which design, manufacture, and assemble medical and in vitro diagnostic medical devices.
• Manufacturers of In Vitro Diagnostic Medical Devices that want to distinguish themselves, and prepare for future IVD regulatory obligations to enter the EU.

EFR Consultancy Package

Related Training

•           Total Package including all the trainings.

•           Package including briefing and training

•           Consultancy and briefing only

•           Training Only

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•          ISO13485 training

•           Understanding and documenting ISO13485 requirements

•           Risk Assessment

• Process Approach internal audit

EFR Consultancy Financial Support

For legible small medium industries in Malaysia, Malaysia government provide grant under SMIDEC Matching grant.

EFR provide advice and assistant for the grant applications.