by Phil Smart

ISO 13485, which is based on the same process approach format as ISO 9001:2000, has been released in July 2003.
ISO13485 is a stand-alone document, which means that there is no requirement to apply for additional certification to ISO 9001. However, there still may be some tangible benefits to being certified to ISO 9001:2000 as well.

With the exception of the process approach and risk management (see Sub-clause 7.1), strict application of the principles of ISO 13485:2003 can result in very few significant changes to most certified QM systems. However, the process approach format does allow for much needed flexibility and coverage of ALL aspects of a quality management system. The new format also lends itself well to high performance management system environments such as Lean Manufacturing and Six Sigma.

As practicing Notified Body auditors and with our membership on ISO/TC 210, RA/QA International can be an invaluable resource in enabling you to achieve ISO 13485: 2003 (and ISO 9001: 2000) certification, effectively and with minimum effort.


Solution:

On-site training of your key staff members and internal auditors to ensure thorough understanding of requirements of the standards;

Documentation analysis, gap analysis and corrective actions to ensure a streamlined yet effective quality management system to comply with both ISO 13485

Internal auditing of your facility to ensure independence and ongoing compliance