Format of documents for its control
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Answer:
Yes, as long as those documents are documented information that support the operation of processes you will need to register them. ISO 9001:2015 in clause 7.5 requires an organization to “Maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confident that the processes are being carried out as planned.”
Basically you will need to document, no matter what format you decide to use, the following:
- Documenting critical portions of the quality management system (QMS) such as its scope, key operational processes, policies, and objectives.
Documenting important, but less critical information that supports the QMS such as process flowcharts, specific quality and operational procedures, schedules, information collection approaches (i.e. forms, surveys), business plans, etc.
These materials can help you to understand document control in ISO 9001:2015:
- Article - New approach to document and record control in ISO 9001:2015: https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/
- Book - Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- ISO 9001:2015 Foundations Course: https://advisera.com/training/iso-9001-foundations-course/
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Dec 18, 2018