ISO 13485 QUALITY SYSTEM MEASUREMENT, ANALYSIS & IMPROVEMENT PROCESS & DOCUMENT

Complete strategy and process for defining how product and the quality management system (QMS) are measured, the data analyzed, and subsequently improved.  (Also lots of tips re establishing and communicating the ‘quality policy’ and QMS goals and monitoring performance.)  This ISO 13485-compliant boilerplate procedure in MS Word meets all ISO 13485 requirements for this ISO section.  Other examples of QMS goals and the recommended ‘metrics’ display are provided in Microsoft Excel or MS Power Point.  To complete this boilerplate, the customer will simply need to insert the information specific to your organization such as your logo, the specific quality system goals and measurements, and add your document numbers.  All AccuFast Consulting boilerplate documents contain notes and tips for the completion of the document and implementation of the process.  
 

ISO 13485 section 8.1, 8.2.1, 8.2.3, 8.2.4, 8.4 & 8.5.1 + all Notes in these sections

1. DIY Do It Yourself Boilerplate documented procedure,
2. Examples of quality management system (QMS) goals,
3. DIY Do It Yourself Boilerplate/recommended ‘metrics board’ template,