Industry-Specific Guidebook and Checklist

• The guidebook will provide the major differences between ISO13485:2003 and ISO13485:2016, the common findings identified, customized recommendations with case studies collected during the Industry-wide Enhancement Scheme such that local SMEs can use it as a self-learning tool to plan and upgrade the current QMS to fulfil the new requirements in ISO13485:2016 effectively.
   

• Recommendations on documentation upgrade with 4 levels of QMS documents and detailed approaches for enhancing operation process to meet the new requirements will be elaborated in the Guidebook to enable the Guidebook readers to build a better understanding on the actual implementation

 

Please press the button below to download the guidebook (in Chinese)