ISO 13485 Quality Manual for Small Business

If you prefer to document an ISO 13485 quality system yourself, you may purchase our "Customize It Yourself" Quality Manual for only $349.  This manual was designed for small businesses, and will save you months of documentation time,  significantly reducing your costs.  Our ISO 13485:2003 quality manual for medical devices includes 24 procedures, and 35 forms/checklists which you customize specifically for your needs.  You will receive sensible/flexible procedures which, when implemented, will reduce paperwork to a minimum and will enable you to significantly improve the quality of your products/services.  

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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 13485:1996 and ISO 13488:1996 - The international quality management system standards for medical device manufacturers have been updated in response to the release of  ISO 9001:2000 and combined into one standard. This international standard has also been adopted by the European Community as EN ISO 13485, European standard for CE Marking, replacing EN 46001.  The new ISO 13485:2003 does not reference the requirements of ISO 9001 but provides medical device manufacturers with a stand alone standard for quality management systems that need to demonstrate compliance to regulatory requirements.

With very few exceptions, countries that required medical device manufacturers to comply with the requirements of the ISO 13485:1996 standard will most likely accept the ISO 13485:2003 standard.  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 quality system standards.  

If you are seeking a quality manual for medical devices that complies with the FDA's CFR 21 Part 820: Quality System Regulation, click here: Quality Manual for Medical Devices

If you are seeking a New Product Development and Introduction Process, click here: New Product Development and Introduction