ISO 9001:2015 Mandatory Documented Information – Documents (Maintain) and Records (Retain)
Many people have been wondering what documents are mandatory in this new 2015 standard version for ISO 9001 quality management system, and in this case will have to be available to transit a quality management system of an organization based on ISO 9001:2008 to the new requirements.
The new ISO 9001:2015 Quality Management System standard requires you to maintain documented information (procedures) and retain documented information (records).
Below are list of documented information that should be maintained and retained for an organization implementing ISO 9001:2015 standard requirements.
Mandatory Documents required by ISO 9001:2015
• Scope of the Quality Management System (4.3)
Scope of the QMS including the products and services covered and the justification of the requirements that cannot be applied to its scope.
• Operation of Processes (4.4.2 a)
Information to support the operations of processes
• Quality Policy (5.2.2)
Quality policy to be available as documented information
• Quality Objectives (6.2.1)
Maintain documented information on the quality objectives
• Control of production and service provision (8.5.1) Information that defines characteristics of products and services, activities to be performed, and the results to be achieved.
Mandatory Records required by ISO 9001:2015
• Operation of Processes (4.4.2 b)
Information necessary to have confidence that processes are being carried out as planned.
• Monitoring and Measurement Resources (220.127.116.11)
Information as evidence of fitness for purpose of monitoring and measurement resources.
• Measurement Traceability (18.104.22.168)
When such standards exist, the basis used for calibration or verification shall be retained as documented information
• Competence (7.2)
Information as evidence of competence.
• Operational Planning and Control (8.1)
Information necessary to have confidence that the processes have been carried out as planned and conform to requirements.
• Requirements Review (8.2.3)
Information describing the results of the review of requirements related to products and services.
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