These areas are specified as being essential components of a medical device quality management system by the various regulatory bodies e.g. > corrective and preventative actions (CAPA) > monitoring customer feedback and satisfaction management policies, planning and commitments > monitoring and measurement of the Quality Management System > labelling, packaging, shipping and distribution > product information, quotations and orders Pack of ISO 13485 templates includes quality management system templates for developing Policies, Standard Operating Procedures (SOPs) and Work Instructions for the following areas of your business: ISO 13485 Quality Management Systems (QM) Manual DOCUMENT NUMBER 01-QM-MED REVISION LEVEL 01 PAGE 10 of 40 1 SCOPE 1.1 General The Quality Management System described in this manual is intended to meet the requirements of the quality management systems standard ISO 13485:2003. What’s included in the Medical Device QMS template pack? Anyone who bought and downloaded the old 2003 version this year, can contact us for a free gap analysis and tracking spreadsheet on the gap between 20. In addition, anyone who purchased the 2003 pack after the 1st March 2016 will receive the 2016 pack free of charge. We are proud to announce the release of the ISO 13485:2016 template pack. ISO 13485 templates: 2016 (latest version) Medicinal Cannabis Industry Conference Sponsors.International GMP Conference 2022 – Speakers.Medicinal Cannabis Cultivation & Regulations.Medicinal Cannabis Conference 2020 – 16/17 November.Cultivation Training Course & Dinner Update.Medicinal Cannabis Cultivation Training.Medicinal Cannabis Consulting Firms | Directory & Consulting.Applying for Licences to Manufacture Medicinal Cannabis API.Applying for Licences to Manufacture Medicinal Cannabis – FDF.Obtaining a Medicinal Cannabis Cultivation Licence in Australia.Extraction, Winterization & Filtration Stages.Propagation, Germination (seeds) & Cloning Stages.Turn Key Medicinal Cannabis Design & Compliance.

Iso 13485 quality manual example