Thursday, February 4, 2016

New Quality Management And Quality Assurance Standards for the 4th Quarter 2015

Document Center Inc. is pleased to announce that the following New Standards on Quality Management And Quality Assurance are now available:


  • BS EN ISO 15378, 2015 Edition, Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • ISO 15378, 3rd Edition, Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • ISO/FDIS 13485, Final draft for proposed 3rd Edition, Medical Devices - Quality Management Systems - Requirements
  • ISO Guide 31, 3rd Edition, Reference materials - Contents of certificates, labels and accompanying documentation
  • JIS Q 9000, 2015 Edition, Quality Management Systems - Fundamentals and Vocabulary (Japanese language only)
  • JIS Q 9001, 2015 Edition, Quality management systems - Requirements (Japanese language only)
  • JIS Q 10002, 2015 Edition, Quality Management - Customer Satisfaction - Guidelines for Complaints Handling in Organizations (Japanese language only)
  • SS EN ISO 9001, 2015 Edition, Quality management systems - Requirements (English language edition)



You can also take a look at my previous post: