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Besides these differences in the structure there are also similarities between iso 9001 2015 and iso 13485 2016.
Medical devices iso 13485 and iso 9001. Iso 13485 is designed to be used by organizations involved in the design production installation and servicing of medical. On the other hand iso 13485 is the standard for a medical device quality management system. The differences between iso 900 and 13485 is that iso 9001 is an international standard for a quality management system. Iso 13485 1996 quality systems medical devices particular requirements for the application of iso 9001.
While most standard revisions now follow iso 9001 s new high level structure iso 13485 does not even though it was released after iso 9001. Iso 9001 is the international standard which provides specifications for a quality management system which can be applied at any organization regardless of industry product or service or company size. Iso 9001 standard is used to install the best possible format when ensuring consumer satisfaction with products and services. Iso 13485 for medical device quality management shares many similarities with iso 9001 the leading global quality management standard with more than 1 1 million certificates worldwide.
Iso 13485 medical devices quality management systems requirements for regulatory purposes is an international organization for standardization iso standard published for the first time in 1996. The iso 13485 iso 9001 medical devices quality management set specifies regulatory requirements for a medical device quality management system that can be used by organizations suppliers and others involved in the various stages of the life cycle of a medical device including design and development production. Being iso 13485 certification compliant shows a commitment to the safety and quality of your medical devices. Both standards emphasize the need to approach both production and business from a risk perspective and to make important decisions based on a risk analysis.
Establish a risk based approach to product development and realization. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices this standard supersedes earlier documents such as en 46001 1993. The primary difference between iso 13485 and iso 9001 for medical devices is the scope of these quality standards. Who is iso 13485 for.
Design and manufacture of medical devices. A medical device is a product such as an instrument machine implant or in vitro reagent that is intended for use in the diagnosis prevention and treatment of diseases or other medical conditions. Iso 13485 certification is a valuable credential put in place to keep professionals and customers safe in clinics hospitals and other medical settings. Iso 13485 2016 is based on the iso 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices.
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