ISO 13485 is a quality standard specific to medical device repair.  The full name of the standard is ISO 13485: 2003, Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.

These are the key requirements of the ISO 13485:  2003 certification:

• For each medical device, there will be a master device record containing device specifications and process requirements that must be established and maintained.
• There must be documentation and maintenance procedures for the issue of advisory notice for all medical devices.  These procedures must be capable of being implemented at any time.
• Records from any customer complaint investigations must be recorded.  If any customer complaint is not followed by corrective or preventative action, this fact with a reasonable explanation must be recorded.
• There must be an established, documented and maintainable procedure for traceability.  The extent traceability must be defined and should facilitate preventative action.
• All Quality Records must be maintained for the expected lifecycle of the device or two years, whichever is greater.
• A documented feedback system to provide early warning of quality issues and for input into corrective and preventative action systems must be established and maintained.
• Any adjustments to previous performed work must be documented in work instructions.  This work instruction must undergo the same authorizations and approvals as the original work instructions.  A determination of any adverse effects of the “rework” on the product shall be documented.
• It is required that batch records be maintained that provide traceability and identify quantities.  These batch records must be verified and authorized.
• Obsolete control documentation must be retained for historical purposes for at least the lifespan of the medical device.
• Environmental factors and/or conditions must be controlled and monitored if they have the potential to adversely affect quality.

 
WHO HAS IT?

Total Scope is the ONLY repair facility that has achieved this quality distinction specific to the medical device industry.  It is not possible to be partly certified - either you are in 100% compliance with the standard, or you are unable to claim certification. 

 
WHY IS IT IMPORTANT?

In today’s budget-conscious environment, consumers look to limit costs while maintaining quality.  The repair market will often accept a lower cost vendor, not accounting for the hidden costs of failed repairs, long downtimes, shipping charges, and costly loaners.  Total Scope, Inc. offers its clients the best of all worlds:  repairs done right the first time, quick turnaround, free shipping, and free loaners.

Medical devices come in close contact with patients and can ultimately save lives.  As such, they demand the highest standards for quality.  Companies that establish and implement an ISO 13485 quality system are taking a world-class approach to the design, development, distribution, and servicing of medical devices.  The ISO 13485 set of practices require accountability, compliance with federal regulations, maintenance of documentation, and traceability of products.  Our ISO 13485 certification exemplifies our unwavering commitment to quality and provides us with a distinct advantage over other medical device repair companies. 

To view our certification, click here .