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Showing posts with the label iso 9001 2015 qms development tips

Format of QMS Documented information: Electronic or Printed?

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Should the final draft of the Quality manual and procedures be printed? What happens if we choose to keep the printed copies? According to the requirements of ISO 9001:2015 (cl. 7.5.2.b) the Organization chooses the documented information format (electronic or printed(hard) copy). Is it more difficult to manage a hard copy of the Manual, including making changes. On the other hand, it is a common practice to have a hard copy of the Manual for familiarization and training purposes. In this case, such a copy is not supposed to be managed, and it will not be updated when changes are made. ISO 9001:2015 Products ISO 14001:2015 Products ISO 50001:2011 Products IMS Products

Remote co-authoring of QMS documented information

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In our modern world is not uncommon when two or more geographically distributed teams would want to work on the QMS documented information together. Can the documents like Manuals and procedures be placed in the cloud where all responsible team members can contribute to it?  How do others handle these kinds of situations? It is a possible practice to co-author QMS documented information remotely.  We offer a couple of simple tips to smooth the process: Assign a Team leader who has the most experience in the QMS development.  Make changes to the documented information having the ‘Track changes’ option ON.  Team leader is solely responsible for accepting the changes and finalizing the document.  This is a good resource on remote collaboration and co-authoring of MS Office documents . All QMS documents and templates we carry are suitable for remote co-authoring. Note: When setting up the co-authoring environment pay close attention to the acc...

Building a Quality Management System

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Building a Quality Management System (QMS) can be divided into 3 phases. QMS Development Phase includes the following activities: - Initial audit of the organization - Evaluation of existing management system ‘As-is’ - Definition of QMS Processes and their Owners. - Forming of the QMS development team. - Executive’s order for QMS development. - ISO 9001:2015 QMS Development team training . - Development of the Organization’s Mission  Strategy  Quality Policy  Quality Objectives  - QMS Processes development - Development of the first edition of the backbone of the Organization’s standards. QMS Implementation Phase includes the following activities: - Employees training - Validation and approval of system QSP - Checking the third level QMS normative documentation. - ‘ Quality Manual ’ Development The following activities should be conducted when preparing the QMS for the ISO 9001:2015 Certification : - QMS Internal auditors training - ...